Complementary And Alternative Medicine Market Report 2020: Players, Countries, Type and Application, Regional Forecast To 2028 – BIZNEWS

Complementary And Alternative Medicine Market offers an in-depth analysis and technical study, with useful facts and figures, of the current and potential market role of Complementary And Alternative Medicine Market. Complementary And Alternative Medicine Market offers information on potential market opportunities and industry drivers, innovations and emerging technologies that will drive these growth trends.

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Executive : The report provides a detailed overview, including Comparison of Definitions, Range, Usage, Output and CAGR (percentage), Type Segmentation, Share, Revenue Status and Outlook, Capability, Demand , Market Drivers, Production Status, Import , Export, Opportunities, Growth Rate for Emerging Markets / Country Countries. The report offers a 360-degree analysis of the competitive environment of the industry.

In-depth Market Analysis: Market size estimation and forecasts were given based on a detailed research methodology tailored to the conditions of the demand for Complementary And Alternative Medicine Market. The Complementary And Alternative Medicine Market report points out national and global business prospects and competitive conditions for Complementary And Alternative Medicine Market. The market research report on Complementary And Alternative Medicine Market was gathered through extensive primary research through interviews , surveys and findings from professional analysts and secondary research. The research also offers a complete qualitative and quantitative evaluation by evaluating data collected from industry analysts and market participants from Complementary And Alternative Medicine Market around key points in the industrys value chain.

Complementary And Alternative Medicine

Market Segmentation : The Complementary And Alternative Medicine Market has been segmented by type (silicon based, fluorine based), by application (automotive, aerospace, photovoltaics, electronic, industrial). Major regions covered in the study include North America, Europe, Asia Pacific, Middle East & Africa, and South America.

Useful discoveries of this research are-

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Understanding Competition: A lot of companies are key players in the Complementary And Alternative Medicine Market which are studied extensively in this report. To strengthen their product portfolio and increase their market share the key manufacturers/ companies are constantly improvising their goods and services. With an emphasis on strategies there have been several primary developments done by major companies such as Nordic Nutraceuticals, Columbia Nutritional, Ramamani Iyengar Memorial Yoga Institute, Herb Pharm, John Schumacher Unity Woods Yoga Centre, Pure Encapsulations, LLC., The Healing Company Ltd, AYUSH Ayurvedic Pte Ltd, and Sheng Chang Pharmaceutical Company. etc.

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Conclusion:The objective of the study is to define the market sizes of the different segments & countries in recent years and to forecast the values. The goal of the market study is to integrate both qualitative and quantitative aspects of the market within each of the regions and countries involved in the report. In addition, the report also offers detailed information on key aspects, such as challenges, driving factors, which will shape future industry development.

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Complementary And Alternative Medicine Market Report 2020: Players, Countries, Type and Application, Regional Forecast To 2028 - BIZNEWS

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Combination Demonstrated Statistically Significant Improvement in Overall Survival,…

KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Combination Demonstrated Statistically Significant Improvement in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy in Phase 3 Study

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the pivotal Phase 3 KEYNOTE-775/Study 309 trial evaluating the investigational use of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer following at least one prior platinum-based regimen. These positive results were observed in the mismatch repair proficient (pMMR) subgroup and the intention-to-treat (ITT) study population, which includes both patients with endometrial carcinoma that is pMMR as well as patients whose disease is microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR). Based on an analysis conducted by an independent Data Monitoring Committee, KEYTRUDA plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in OS, PFS and ORR versus chemotherapy (treatment of physicians choice [TPC] of doxorubicin or paclitaxel). The safety profile of the KEYTRUDA plus LENVIMA combination was consistent with previously reported studies. Merck and Eisai will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, and plan to present these results at an upcoming medical meeting.

Women with advanced endometrial cancer are faced with high mortality rates and limited treatment options following initial systemic therapy, said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. These are the first results from a Phase 3 trial of a combination regimen including immunotherapy in advanced endometrial carcinoma that have shown a statistically significant improvement in overall survival, progression-free survival and objective response rate versus chemotherapy. Merck and Eisai are dedicated to continuing to research the KEYTRUDA plus LENVIMA combination and discover new approaches to address unmet needs for devastating diseases such as endometrial carcinoma.

We are encouraged by the data observed in KEYNOTE-775/Study 309, which represent a possible step forward for patients impacted by advanced endometrial carcinoma and support the results seen in the advanced endometrial cancer cohort of KEYNOTE-146/Study 111, said Dr. Takashi Owa, Vice President, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. As more clinical data from the LEAP (LEnvatinib And Pembrolizumab) program are revealed, we cannot help but be energized by the trajectory of our collaboration with Merck and the benefits we hope to provide to patients together. Most importantly, we are grateful for the trust that the patients and healthcare professionals who participated in this trial have shown us.

KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the U.S. Food and Drug Administrations (FDA) 2019 accelerated approval of the KEYTRUDA plus LENVIMA combination for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This accelerated approval was based on tumor response rate and durability of response and was the first approval granted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. Under Project Orbis, Health Canada and Australias Therapeutic Goods Administration (TGA) granted conditional and provisional approvals, respectively, for this indication.

Merck and Eisai are studying the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in 13 different tumor types across 20 clinical trials, including a Phase 3 trial evaluating the combination in the first-line setting for patients with advanced endometrial carcinoma (LEAP-001).

About KEYNOTE-775/Study 309

KEYNOTE-775/Study 309 is a multicenter, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT03517449) evaluating KEYTRUDA in combination with LENVIMA in patients with advanced endometrial cancer following at least one prior platinum-based regimen. The dual primary endpoints are OS and PFS, as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version (RECIST) v1.1. Select secondary endpoints include objective response rate (ORR) by BICR per RECIST v1.1 and safety/tolerability. Of the 827 patients enrolled, 697 patients had tumors that were non-MSI-H or pMMR, and 130 patients had tumors that were MSI-H or dMMR. Patients were randomized 1:1 to receive:

About Endometrial Cancer

Endometrial cancer begins in the inner lining of the uterus, which is known as the endometrium and is the most common type of cancer in the uterus. In 2018, it was estimated there were more than 382,000 new cases and nearly 90,000 deaths from uterine body cancers worldwide (these estimates include both endometrial cancers and uterine sarcomas; more than 90% of uterine body cancers occur in the endometrium, so the actual numbers for endometrial cancer cases and deaths are slightly lower than these estimates). In the U.S., it is estimated there will be almost 66,000 new cases of uterine body cancer and nearly 13,000 deaths from the disease in 2020. The five-year survival rate for advanced or metastatic endometrial cancer (stage IV) is estimated to be approximately 17%.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1). All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatment. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatment and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

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Animal Stem Cell Therapy Marketresearch report is the new statistical data source added byA2Z Market Research.

Animal Stem Cell Therapy Market is growing at a High CAGR during the forecast period 2021-2027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market.

Animal Stem Cell Therapy Marketresearch is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis.

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Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

Top Key Players Profiled in this report are:

ANIMAL CELL THERAPIES, Celavet, Animacel, VETSTEM BIOPHARMA, Cell Therapy Sciences, Magellan Stem Cells, Cells Power Japan, Animal Care Stem, Aratana Therapeutics, VetCell Therapeutics, MediVet Biologic, U.S. Stem Cell, J-ARM

The key questions answered in this report:

Various factors are responsible for the markets growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Animal Stem Cell Therapy market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Animal Stem Cell Therapy markets trajectory between forecast periods.

Global Animal Stem Cell Therapy Market Segmentation:

Market Segmentation: By Type

DogsHorsesOthers

Market Segmentation: By Application

Veterinary HospitalsResearch Organizations

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Regions Covered in the Global Animal Stem Cell Therapy Market Report 2021:The Middle East and Africa(GCC Countries and Egypt)North America(the United States, Mexico, and Canada)South America(Brazil etc.)Europe(Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific(Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

The cost analysis of the Global Animal Stem Cell Therapy Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.

The report provides insights on the following pointers:

Market Penetration:Comprehensive information on the product portfolios of the top players in the Animal Stem Cell Therapy market.

Product Development/Innovation:Detailed insights on the upcoming technologies, R&D activities, and product launches in the market.

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.

Market Development:Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.

Market Diversification:Exhaustive information about new products, untapped geographies, recent developments, and investments in the Animal Stem Cell Therapy market.

Table of Contents

Global Animal Stem Cell Therapy Market Research Report 2021 2027

Chapter 1 Animal Stem Cell Therapy Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Animal Stem Cell Therapy Market Forecast

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Comprehensive Report on Animal Stem Cell Therapy Market 2021 | Size, Growth, Demand, Opportunities & Forecast To 2027 | ANIMAL CELL THERAPIES,...

I Peace, Inc. and Avery Therapeutics announce collaboration to bring iPSC derived cell therapy for heart failure to the clinic – PRNewswire

Avery Therapeutics is projected to be one of the first companies in the US to seek approval for a clinical trial using iPSC-derived technology for heart failure. The goal of this collaboration is to develop a new off-the-shelf treatment to improve the quality of life of patients suffering from heart failure, a debilitating disease that affects tens of millions of people worldwide.

The iPSCs are manufactured at I Peace's state-of-the-art GMP facility in Kyoto, Japan, under comprehensive validation programs of the facility, equipment, and processes including donor recruiting, screening, blood draw, iPSC generation, storage, and distribution. I Peace has obtained a US-based independent institutional review board (IRB) approval for its process of donor sourcing for commercial-use iPSCs. The facility is designed to be PMDA and USFDA compliant.

As Avery Therapeutics expects to expand the application of its regenerative medicine technology to various types of heart diseases and beyond, iPSCs are the key enabling technology for quality and future scalability. This agreement provides a solid foundation to improve the welfare of those suffering from diseases through advancement of tissue-engineered therapeutics.

"We are thrilled to announce this collaboration with I Peace. It is a big step forward in the development of novel cell-based therapeutics for unmet medical needs. Through this collaboration, I Peace brings deep iPSC development and manufacturing expertise to enable Avery's proprietary MyCardia cell delivery platform technology. Together we hope to positively impact millions of patients worldwide in the near future," Said Jordan Lancaster, PhD, Avery Therapeutics' CEO.

This agreement reflects an innovative collaboration involving multiple locations internationally and marks a significant milestone for both I Peace, Inc. and Avery Therapeutics to pursue one of the first US clinical trials using iPSC technology in the area of heart diseases. Koji Tanabe, PhD, founder and CEO of I Peace stated: "By combining I Peace's proprietary clinical grade iPSC technology and Avery's tissue engineering technology, we can bring the regenerative medicine dream closer to reality. We are very excited by Avery's technology and look forward to continue working together."

About I Peace, Inc

I Peace, Inc. is a global supplier of clinical and research grade iPSCs. It was founded in 2015 in Palo Alto, California, USA by Dr. Tanabe, who earned his doctorate at Kyoto University under Nobel laureate Dr. Shinya Yamanaka. I Peace's mission is to alleviate the suffering of diseased patients and help healthy people maintain a high quality of life by making cell therapy accessible to all. I Peace's state-of-the-art GMP facility and proprietary manufacturing platform enables the fully-automated mass production of discrete iPSCs from multiple donors in a single room. Increasing the available number of clinical-grade iPSC lines allows I Peace customers to take differentiation propensity into account to select the most appropriate iPSC line for their clinical research at significantly reduced cost. I Peace aims to create iPSCs for every individual that become their stem cell for life.

Founder, CEO: Koji TanabeSince: 2015Head Quarter: Palo Alto, CaliforniaJapan subsidiary: I Peace, Ltd. (Kyoto, Japan)Cell Manufacturing Facility: Kyoto, JapanWeb: https://www.ipeace.com

About Avery Therapeutics

Avery Therapeutics is a company developing advanced therapies for patients suffering from cardiovascular diseases. Avery's lead candidate is an allogeneic tissue engineered cardiac graft, MyCardia in development for treatment of chronic heart failure. Using Avery's proprietary manufacturing process MyCardia can be manufactured at scale, cryopreserved, and shipped ready to use. Avery is leveraging its proprietary tissue platform to pursue other cardiovascular indications. For more information visit: AveryThera.com. Follow Avery Therapeutics on LinkedInand Twitter.Since: 2016Headquarter: Tucson, AZWebsite: https://www.AveryThera.com

SOURCE I Peace, Inc.

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I Peace, Inc. and Avery Therapeutics announce collaboration to bring iPSC derived cell therapy for heart failure to the clinic - PRNewswire

Creative Medical Technology Holdings Announces Successful Application of ImmCelz Immunotherapy for Treatment of Stroke – PRNewswire

PHOENIX, Dec. 16, 2020 /PRNewswire/ --Creative Medical Technology Holdings Inc., (OTC CELZ) announced today positive preclinical data supporting the utilization of its ImmCelz cell based immunotherapy for treatment of stroke. In an animal model of ischemia stroke, the middle cerebral artery ligation model, administration of ImmCelz resulted in 34% reduction in infarct volume, whereas control bone marrow mesenchymal stem cells reduced infarct volume by 21%. Additionally, improvements in functional recovery where observed using the Rotarod test. At 28 days after induction of stroke the animals receiving ImmCelz had superior running time (92% of non-stroke controls) compared to animals which received bone marrow mesenchymal stem cells (73% of non-stroke control). Animals that received saline had a running time that was 50% of non-stroke controls.

"The regenerative potential of immune cells that have been programmed by stem cells is a fascinating and novel area of research." Said Dr. Amit Patel, coinventor of ImmCelz, and board member of the Company. "Conceptual advantages of using reprogrammed T cells include higher migratory ability due to smaller size, as well as ability to replicate and potentially form "regenerative memory cells."

"This data, which is covered by our previous filed patents, such as no. 15/987739, Generation of autologous immune modulatory cells for treatment of neurological conditions, demonstrate that immune modulation via this stem cell based method may be a novel and superior way of addressing the $30 billion dollar market for stroke therapeutics1." Said Dr. Thomas Ichim, coinventor of the patent and Chief Scientific Officer of the Company. "The fact that this technology, which has priority back to 2017, is demonstrating such stunning results, motivates us to consider filing an Investigational New Drug Application for use in stroke."

Creative Medical Technology Holdings possesses numerous issued patents in the area of cellular therapy including patent no. 10,842,815 covering use of T regulatory cells for spinal disc regeneration, patent no. 9,598,673 covering stem cell therapy for disc regeneration, patent no. 10,792,310 covering regeneration of ovaries using endothelial progenitor cells and mesenchymal stem cells, patent no. 8,372,797 covering use of stem cells for erectile dysfunction, and patent no. 7,569,385 licensed from the University of California covering a novel stem cell type.

"While stroke historically has been a major area of unmet medical need, the rise in stroke cases , as well as the fact that younger people are increasingly falling victim to stroke, strongly motivates us to accelerate our developmental programs and to continue to explore participation of Big Pharma in this space." Said Timothy Warbington, President and CEO of the Company. "We are eager to replicate the existing experiments start compiling the dossier needed to take ImmCelz into humans using the Investigational New Drug Application (IND) route through the FDA."

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of urology, neurology and orthopedics and trades on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website atwww.sec.gov.

Timothy Warbington, CEO[emailprotected] CreativeMedicalHealth.com

Creativemedicaltechnology.comwww.StemSpine.comwww.Caverstem.comwww.Femcelz.com

1 Stroke Management Market Size Forecasts 2026 | Statistics Report (gminsights.com)

SOURCE Creative Medical Technology Holdings, Inc.

http://creativemedicaltechnology.com

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Creative Medical Technology Holdings Announces Successful Application of ImmCelz Immunotherapy for Treatment of Stroke - PRNewswire

Glycostem and Ghent University sign license agreement on NK cell therapy technology – PRNewswire

OSS, Netherlands, Dec. 17, 2020 /PRNewswire/ --Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, and Ghent University (UGent) have signed a license agreement for an innovative NK cell production technology. Ultimately, this agreement will bring significant benefit to targeted treatment of patients suffering from cancer. The agreement not only opens up new opportunities for development of NK-antibody combination therapies but also has significant positive impact on the production time of Glycostem's lead product oNKord and its second (CAR-NK) and third (TCR-NK) generation therapies viveNKTM.

"This license agreement offers new opportunities for more targeted treatment of cancer patients. By using UGent's technology we are able to increase the expression of CD16 receptors resulting in an increase of the NK-cell's activity and its antibody binding properties. When a patient's immunity is weak, administering NK-cells will boost the patient's immune system and increase the antibody's therapeutic effectiveness," explains Troels Jordansen, CEO at Glycostem.

Glycostem's NK-cell based therapies are manufactured in its in-house GMP licensed facility. "Ghent University's technology has the potential to almost halve the time needed for NK cell progenitor cells to differentiate into fully functional NK-cells. By incorporating this in our processes both our manufacturing time and cost-effectiveness will be affected very positively without negative effect on the potency of the NK cells. This is an important part of paving the way for further upscaling the production of our NK-cells," says Troels Jordansen.

"We are glad to see our research translated to a clinical setting as it is based on many years of fundamental research into NK cell biology," tells Prof. Georges Leclercq, head of the UGent research team and group leader in the Cancer Research Institute Ghent (CRIG). "We hope that with this collaboration, we can positively impact the lives of many patient's affected by difficult to treat cancers."

Dr. Dominic De Groote (UGent Business Development) further explains: "This partnership is the result of continuing efforts by Ghent University and Ghent University Hospital to become a leading academic and clinical center for cell-based therapies. This technology is part of our growing portfolio of oncology and Advanced Therapy Medicinal Products (ATMP) related assets that we are actively developing from the bench to the bedside through our translational platforms."

Taking cellular immunotherapy to the next level

Glycostem is focused on developing first, second and third generation cancer treatments based on NK-cells. This licensing deal will affect Glycostem's full portfolio. After a successful phase I study Glycostem initiated a first-of-its-kind pivotal trial in acute myeloid leukemia (AML) with in-house manufactured nonmodified NK cells (oNKord). Over the coming months, AML patients will receive this form of treatment as part of a phase I-IIa trial. A pivotal phase IIa trial for Multiple Myeloma (MM) patients is expected to start second half of 2021. This makes Glycostem one of the frontrunners in this promising field of cellular immunotherapy.

About Glycostem

Netherlands-based Glycostem Therapeutics BV, a clinical stage biotech company, develops allogeneic cellular immunotherapy to treat several types of cancer. By harnessing the power of stem cell-derived Natural Killer (NK) cells, Glycostem's products are a safe alternative to CAR-T-cells. Glycostem's lead product, oNKord, is manufactured from allogeneic raw material and is available off-the shelf. Thanks to its nine patent families, longstanding technical expertise and resources, as well as 'Orphan Drug Designation', Glycostem has secured a leadership position in the global NK-cell market.

oNKord is produced in a closed system (uNiKTM) in Glycostem's state-of-the-art and GMP (Good Manufacturing Practice) licensed production facility in the Netherlands, from which it can be distributed globally. The production technology includes ex vivo generation of high numbers of NK-cells with a high degree of purity for clinical applications. oNKord successfully passed phase I clinical trial (elderly and frail AML - Acute Myeloid Leukemia - patients), providing solid safety data and strong indication of clinical activity, including response on MRD (Minimal Residual Disease). Results indicate that oNKord may be safely infused in AML patients.

Glycostem is furthermore developing a range of CAR-NK and TCR-NK products in-house and in cooperation with global partners.

Glycostem Therapeutics BV http://www.glycostem.com

Foot note: "oNKord" is a registered trademark of Glycostem in the US and in Europe. Trademark registrations of "viveNK" and "uNiK" are pending.

About Ghent University

Ghent University (UGent) is a major Belgian university located in the heart of Europe. Our organization is dedicated to research and innovation with over 5,500 researchers active in a wide area of life, physical and social sciences. Strong partnerships with the Ghent University Hospital (1000+ beds), VIB, IMEC and global leaders in academia and pharma/biotech industry thrive life science innovation at our university and is part of the thriving Belgian biotech region. Our translational platforms such as CRIG (focus on cancer) and GATE (focus on advanced therapy medicinal products) facilitate to bring science to the patient.

Prof. Georges Leclercq has a longstanding and internationally recognized expertise in differentiation and function of NK cells. The recent focus of his research group is to reveal the role of several transcription factors in the differentiation of human hematopoietic stem cells into mature NK cells, and in the maintenance and function of these mature NK cells. The ultimate aim is to attribute to improved NK-based cancer immunotherapy.

Cancer Research Institute Ghent http://www.crig.ugent.be

SOURCE Glycostem

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Glycostem and Ghent University sign license agreement on NK cell therapy technology - PRNewswire

Stem Cell Therapy Market to See Massive Growth by 2026 Osiris Therapeutics, NuVasive – Farming Sector

The latest version of the 2020 market study on Stem Cell Therapy Market comprising 104 with market data Tables, Charts, Graphs, and Figures which are easy to understand with showcased in-depth analysis.

The Coronavirus Pandemic (COVID-19) has affected every aspect of life worldwide. This has led to several changes in market conditions. The report covers the rapidly changing market scenario and the initial and future impact assessments.

The global Stem Cell Therapy market was valued at $XX million in 2019, and Research analysts predict the global market size will reach $XX million by the end of 2029, growing at a CAGR of XX% between 2020 and 2029.

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As per the research and study, the market has settled its presence worldwide. Stem Cell Therapy Market Research study offers a comprehensive evaluation of the Market and comprises a future trend, current growth factors, focused opinions, details, and industry certified market data.

Glancing to 2020, the global market expected to be a significant year for Stem Cell Therapy Market in terms of growth and revenue.

Almost all companies who are listed or profiled are being to upgrade their applications for end-user experience and setting up their permanent base in 2020. This report focused and concentrate on these companies including Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed, Takeda (TiGenix).

Furthermore, the research contributes an in-depth overview of regional level break-up categorized as likely leading growth rate territory, countries with the highest market share in past and current scenario. Some of the geographical break-up incorporated in the study are North America (United States, Canada and Mexico), Europe (Germany, UK, France, Italy, Russia and Spain etc.), Asia-Pacific (China, Japan, Korea, India, Australia and Southeast Asia etc.), South America (Brazil, Argentina and Colombia etc.), Middle East & Africa (South Africa, UAE and Saudi Arabia etc.).

With the Stem Cell Therapy market forecast to expand CAGR% in 2020 and with X-X-X-X supposed to be a big beneficiary, it is better positioned than Z-Z-Z-Z for 2020.

According to the AMR market study, Recent trends in consumer preferences market segments such as type, the application will be more challenging. Stem Cell Therapy market segment sales will traverse the $$ mark in 2020.

Unlike classified segments successful in the industry such as by Type (Autologous, Allogeneic) and by End-Users/Application (Musculoskeletal Disorder, Wounds & Injuries, Cornea, Cardiovascular Diseases, Others).

The 2020 version of the Stem Cell Therapy market study is a further split down / narrowed to highlight the latest emerging twist of the industry.

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Due to a change in consumer preferences with a review on the latest sales and revenue report submissions, Major vendors in the Global market are trying to get the attention of end-users or consumers by Offerings and additional services.

With using the latest technology and analysis on demand-side, Key players are getting in consumer behavior and their changing preferences.

Again, big investment firms or giants are willing to put more capital to get a key players performance in the market for new applications or products.

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Research Objectives and Purpose

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Thanks for reading this article, you can also get individual chapter wise section or region wise report versions like North America, Western / Eastern Europe or Southeast Asia.

With the given market data, Research on Global Markets offers customizations according to specific needs. Write to AMR

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Medicine by Design symposium highlights importance of convergence in regenerative medicine and human health – News@UofT

Researchersarepoised to makeunprecedentedbreakthroughsinhuman health thanks toadvancesin biomedical and computational sciencesthathave drivencritical tools and technologiessuch as genetic engineering,synthetic biology, andartificial intelligence.

Thats the messageDr. VictorDzau, president oftheU.S.National Academy ofMedicine, delivered to Medicine by Designs fifthannual symposium on Dec. 7 and 8.

Thevirtual event, whichattracted more than 500 registrants from across North America, focused on the theme of better science throughconvergence theintegration of approaches from engineering, science, medicine and other fields to expand knowledge and spark innovation.

I think for younger people, there is really not a more exciting time, in my opinion, to do research than now, because we can really see that some of the initial concepts that people have about health and medicinecan be realizedand truly transform the way we do health andmedicine.

In his talk, Dzau focused on the National Academy of MedicinesHealthy Longevity Global Challenge,an international competition that aims to catalyze transformative ideas and breakthroughs that will extend human healthand lifespan.

That program is one of the inspirations for Medicine by DesignsGrand Questions Program, which seeks to fund bold research that promises dramatically better health outcomes by changing the future of regenerative medicine.

Through our Grand Questions Program, we are thinking about what comes next and how to overcome fundamental problems in regenerative medicine,saidMichael Sefton, executive director of Medicine by Design andUniversity Professorin the department of chemical engineering and applied chemistry and theInstitute of Biomedical Engineeringat the University of Toronto.

We have a broad definition of regenerativemedicine, andpreventing degeneration can be as important as the next cell therapy.

Sefton pointed out that the symposium theme of better science through convergencefocusedon a key aspect of Medicine by Design:That we combine campus and hospital investigators, transformative science and translational elements, junior and senior investigators, and local and international collaborators, to address fundamental problems in regenerative medicine.

Thesymposium also featured a talk byRobert Langer, David H. KochInstitute Professorin the department of chemical engineeringat the Massachusetts Institute of Technology. The most highly cited engineer in history, he spoke about lessons helearnedfromhisscientific and business successes and how he decidedto be his own champion after facing criticism for his novel ideas early in his career.

If you try to do things whether its convergence, or things that a lot of people disagree with you have tohang in there, Langer said.Having good intellectual property has been key toraising the funds to do these things, and medicine is an incredibly expensive thing.

And finally, you really need teams that are super driven, and I think these startup companies have been a wonderful way to do this.

The symposium was organized around four sessions: translation, inflammation, biomaterials andimmunoengineering.Invited speakers from across North AmericaincludedKim Warren(AVROBIO),Kenneth Walsh(University of Virginia),Sarah Heilshorn(Stanford University)andMegan Levings(University of British Columbia).

All speakers fromU of T and its partnerhospitals were lead investigators on Medicine by Designs multi-disciplinary, multi-institution team projects. They included:John Dick,Clinton RobbinsandShaf Keshavjee(University Health Network (UHN));Molly Shoichet(department of chemical engineering and applied chemistry and Institute of Biomedical Engineering);Juan CarlosZiga-Pflcker(Sunnybrook Health Sciences Centre);andAndras Nagy(Sinai Health System).

Ted Sargent, vice-president of research and innovation, and strategic initiatives,and a University Professor in the Edward S. Rogers Sr. department of electrical and computer engineering,opened the symposium by congratulatingMedicine by Design on its successful mid-term review, which was conducted in early 2020 by a panel of international experts and theCanada First Research Excellence Fund(CFREF), which funds Medicine by Design.

Medicine by Design has amplified existing areas ofexcellenceatU of Tandour partner hospitals (Toronto Academic Health Sciences Network),and pushed the boundaries of regenerative medicine to tackle cell-based therapies, strategies for endogenous repair and the use of a stem cell lens to target the triggers of disease,Sargent said. In fact, Medicine by Design is such a compelling collaborative, cross-disciplinary initiative that itis a template fora new class of initiatives at the University ofToronto theInstitutional Strategic Initiativesportfolio whosepurpose is to mobilize ambitious,groundbreaking, collaborative, multi-institutional research networks that tackleimportantresearch problems, buildmajorexternal partnershipsboth with industry and emerging companies as well as with global academic peers;and foster societal impact.

They support the pursuit of grand challenges and bold ideas across disciplinary boundaries,further elevate U of Ts profile in high priority research areas of strategic importance,and enable us to realize transformational impacts on issues of major societal import.

The symposium also offered an opportunity for almost 45trainees to present their research during a poster session.KerstinKaufmann, a post-doctoral fellow in the laboratory ofJohn Dick(Princess Margaret Cancer Centre,UHN), won first place.JonathanLabriola, apost-doctoral fellowinSachdev Sidhuslab(Donnelly Centre for Cellular and Biomolecular Research, U of T), placed second, whileSabihaHacibekiroglu, a post-doctoral fellow in the lab ofAndras Nagy(Lunenfeld-Tanenbaum Research Institute, UHN)placed third.The awards were sponsored by STEMCELL Technologies.

YasamanAghazadeh,a post-doctoral fellow in the labsofCristina Nostro(McEwen Stem Cell Institute, UHN)andSara Nunes Vasconcelos(Toronto General Hospital Research Institute,UHN),won theCCRMTranslation Awardfor the poster with the greatest translational potential.AndAi Tian, a post-doctoral fellow fromJulien Muffatslab (The Hospital for Sick Children), won thePeoples Choice Award, a new award this year that wasdetermined byvotingby symposium attendeesand sponsored byBlueRockTherapeutics.

Funded by a $114-million grant from CFREF, Medicine by Design brings together more than 145principal investigators at the University of Toronto and its affiliated hospitals to work at the convergence of engineering,medicineand science. It builds on decades of made-in-Canada excellence in regenerative medicine dating back to the discovery of stem cells in the early 1960s by Toronto researchers James Till andErnest McCulloch.

Regenerative medicine uses stem cells to replace diseased tissues and organs, creating therapies in which cells are the biological product. Regenerative medicine can also mean triggering stem cells that are already present in the human body to repair damaged tissues or to modulate immune responses. Increasingly, regenerative medicine researchers are using a stem cell lens to identify critical interactions or defects that prepare the ground for disease, paving the way for new approaches to preventing disease before it starts.

(Photo of Robert Langer by Jason Alden)

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Medicine by Design symposium highlights importance of convergence in regenerative medicine and human health - News@UofT

Global NK Cell Therapy and Stem Cell Therapy Market: Development, Current Analysis and Estimated Forecast to 2025 – The Courier

The research report on NK Cell Therapy and Stem Cell Therapy Market gives thorough insights regarding various key trends that shape the industry expansion with regards to regional perspective and competitive spectrum. Furthermore, the document mentions the challenges and potential restrains along with latent opportunities which may positively impact the market outlook in existing and untapped business spaces. Moreover, it presents the case studies, including the ones related to COVID-19 pandemic, to convey better understanding of the industry to all the interested parties.

The recent market trend of increasingly using NK Cell Therapy and Stem Cell Therapy for understanding the development of a disease extensively fuel the growth of this market in the coming years. Another trend that will aid the growth of the global NK Cell Therapy and Stem Cell Therapy market is the escalating demand for personalized medicine. Extensive investments are being made by various organizations, pharmaceutical companies, and governments for the research and development of drugs, and this is another trend that is benefiting the growth of the global NK Cell Therapy and Stem Cell Therapy market. This is because NK Cell Therapy and Stem Cell Therapy techniques enable researchers to compare NK Cell Therapy and Stem Cell Therapy changes between disease samples and normal samples. Public health can thus be analyzed as the changes in NK Cell Therapy and Stem Cell Therapy are influenced by internal biological system and environment directly.

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The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include: Osiris Therapeutics, Chiesi Pharmaceuticals, Molmed, Takeda Pharmaceutical, Medi-post, Chipscreen Biosciences, Affimed NV, JCR Pharmaceutical, Pharmicell, Innate Pharma SA, NuVasive, Anterogen, Altor BioScience Corporation.

NK Cell Therapy and Stem Cell Therapy Market Segmentation:

In market segmentation by types of NK Cell Therapy and Stem Cell Therapy, the report covers-

NK Cell TherapyStem Cell Therapy

In market segmentation by applications of the NK Cell Therapy and Stem Cell Therapy, the report covers the following uses-

Hospital & clinicsRegenerative medicine centersDiagnostic centersResearch institutesOthers

Regional Analysis for NK Cell Therapy and Stem Cell Therapy Market-:

1) North America- (United States, Canada)

2) Europe- (Germany, France, UK, Italy, Russia, Spain, Netherlands, Switzerland, Belgium)

3) Asia Pacific- (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Vietnam)

4) Middle East & Africa- (Turkey, Saudi Arabia, United Arab Emirates, South Africa, Israel, Egypt, Nigeria)

5) Latin America- (Brazil, Mexico, Argentina, Colombia, Chile, Peru)

The report provides insights on the following pointers :

Market Penetration: Comprehensive information on the product portfolios of the top players in the Supply Chain Analytics market.

Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market

Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies

Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Supply Chain Analytics market

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Table of Content

Chapter 1 NK Cell Therapy and Stem Cell Therapy Introduction and Market Overview

Chapter 2 Executive Summary

Chapter 3 Industry Chain Analysis

Chapter 4 Global NK Cell Therapy and Stem Cell Therapy Market, by Type

Chapter 5 NK Cell Therapy and Stem Cell Therapy Market, by Application

Chapter 6 Global NK Cell Therapy and Stem Cell Therapy Market Analysis by Regions

Chapter 7 North America NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 8 Europe NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 9 Asia Pacific NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 10 Middle East and Africa NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 11 South America NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 12 Competitive Landscape

Chapter 13 Industry Outlook

Chapter 14 Global NK Cell Therapy and Stem Cell Therapy Market Forecast

Chapter 15 New Project Feasibility Analysis

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Global NK Cell Therapy and Stem Cell Therapy Market: Development, Current Analysis and Estimated Forecast to 2025 - The Courier

ONK Therapeutics Announces Three Exclusive Option License Agreements, Which Extend and Strengthen its Dual-Targeted NK Cell Therapy Pipeline -…

GALWAY, Ireland, & SAN DIEGO, Calif.--(BUSINESS WIRE)--ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has secured three new exclusive option license agreements which strengthen its off-the-shelf, dual-targeted natural killer (NK) cell therapy platform and extend its pre-clinical pipeline to four programs across both hematological and solid tumors.

The first option agreement, with Cellerant Therapeutics, gives exclusive rights to a humanized CLEC12A scFv binder. CLEC12A is strongly expressed by blasts in the majority of AML patients. The option to license has enabled ONK to expand its pre-clinical product portfolio, launching a fourth program (ONKT104). This dual-targeted approach combines the CLEC12A CAR with a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting death receptor 4 (DR4).

While expressed on leukemic stem cells, CLEC12A is absent from normal hematopoietic stem cells and we thus expect that our dual-targeted NK cell therapy approach should enable safe targeting, with a reduced risk of prolonged aplasia in AML, said Prof Michael ODwyer MD, ONK Therapeutics co-founder, and CSO.

The second agreement in-licenses a humanized, tumor-specific antibody targeting an aberrantly glycosylated tumor-associated form of MUC1 (TA-MUC1) from Glycotope GmbH. Multiple solid tumor types express the mucin MUC1, including non-small cell lung cancer, breast cancer, and ovarian cancer. This antibody will be integrated into ONKs pre-clinical program ONKT103, for solid tumors.

Non-selective targeting of MUC1 could be problematic since the target is also expressed by healthy tissues, but ODwyer explains how ONKs dual-targeted approach can be used to address this. We have designed a CAR tailored to the glycosylation pattern distinct to tumor-associated MUC1 with specific recognition of the carbohydrate antigens Tn and T on MUC1, the expression of which is restricted to cancer cells. Glycotope has identified the glycosylation pattern as a way to unlock the potential of TA-MUC1 as a solid tumor target. ONK is thus set to bring the natural benefits of NK cells over T cells to bear on TA-MUC1, in a tumor-specific fashion, while also further boosting efficacy and countering resistance through the use of our TRAIL variant targeting DR5, he said.

ONKs unique platform approach combines the expression of a chimeric antigen receptor (CAR) and a high affinity, membrane-bound TRAILv. The incorporation of these two humanized scFvs has the potential to minimize the risk of immunogenicity in the allogeneic setting.

ONK is also exploring several innovative strategies to improve the homing of NK cells. This is an important consideration as ex-vivo expansion can lead to changes in chemokine receptor expression. Through this new license agreement with the NIH, ONK plans to enforce the expression of CCR7, which is downregulated on NK cell expansion. This may improve the homing of NK cells to lymph nodes and is expected to be particularly useful for ONKs off-the-shelf CD19 program targeting B cell lymphoma, ONKT101, which is partnered with Avectas.

ONK is making rapid progress since it announced its most recent financing in October. Chris Nowers, ex Kite Pharma Head of Europe, who joined at that time as Chief Executive Officer, said: The recent American Society of Hematology meeting highlighted the NK cell therapy area as offering great hope as the next generation of advanced cell therapies. We believe our best-in-class off-the-shelf, dual-targeted NK cell therapy platform has the potential to improve performance and overcome some of the shortcomings seen with earlier approaches. These new licensing activities strengthen and expand our programs and illustrate our ambition and strategy to become a leader in this exciting field.

The company recently expanded its operations into the USA, moving into JLABS @ San Diego, Johnson & Johnson Innovations flagship facility, at the heart of San Diegos precision medicine and cell therapy cluster. This represents a second facility that complements its main R&D team and operations in Galway, Ireland. The companys recruitment drive across both facilities has been rapid and the company continues to expand its capability in key areas, including NK cell biology, construct design, gene editing, and process development.

-Ends-

ONK Therapeutics http://www.onktherapeutics.com ONK Therapeutics Ltd is an innovative cell therapy company dedicated to developing the next generation of off-the-shelf, dual-targeted NK cell therapies targeting solid and hematological cancers.

The company was founded in 2015, by Prof. ODwyer MD, of NUI Galway, an expert in translational multiple myeloma research, the tumor microenvironment, and exploitation of NK cells as cellular immunotherapy. Its core proprietary platform is based on a dual-targeted NK cell expressing both a chimeric antigen receptor (CAR) targeting a known tumor antigen and a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting the death receptor pathway (i.e. DR4 or DR5). This unique approach has the potential to enhance efficacy by addressing both intrinsic (e.g. CAR engagement of a tumor-specific antigen) and extrinsic (e.g. signaling through the death receptor pathway) apoptotic pathways and to reduce the susceptibility to possible target antigen escape through the engagement of tumor antigen-independent TRAILv.

Its pre-clinical pipeline comprises four programs;

In addition to the unique dual-targeted NK cell therapy platform, the company has a strong research focus on strategies to enhance homing and persistence, and overcome exhaustion, including the exploration of proprietary gene edits, such as the deletion of checkpoint inhibitory receptors in NK cells.

ONK Therapeutics is headquartered in the med-tech hub of Galway, Ireland, with a wholly-owned US subsidiary, ONK Therapeutics, Inc. based at JLabs @ San Diego. Shareholders include Acorn Bioventures, ALSHC (principally Seamus Mulligan), and Enterprise Ireland.

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About Avectas - http://www.avectas.com Avectas is a cell engineering technology business that has developed a unique delivery platform, Solupore to enable the ex vivo manufacture of cell therapy products, which have high in-vivo functionality.

Glycotope http://www.glycotope.com Glycotope is a biotechnology company utilizing a proprietary technology platform to develop highly tumor-specific monoclonal antibodies called GlycoBodies. GlycoBodies bind to targets (GlycoTargets) tumor-specific carbohydrate structure dependent, enabling the development of highly-specific immunotherapies across a broad range of cancer indications. Glycotope has to date discovered in excess of 150 GlycoTargets with GlycoBodies against eight of these targets currently under development.

Each GlycoBody can be developed in an array of modalities with different modes of action providing a unique offering in the (immuno) oncology space. Currently, six clinical and pre-clinical programs based on the GlycoBody technology are under development by Glycotope or its licensing partners.

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ONK Therapeutics Announces Three Exclusive Option License Agreements, Which Extend and Strengthen its Dual-Targeted NK Cell Therapy Pipeline -...

New Combination Therapy Tested By Children’s May Offer Hope For Leukemia Patients – WVXU

Cancer cells pose an uncanny ability to make new cells and dodge drugs, "somewhat like would-be robbers hacking the bank's alarm code," one doctor explains. But researchers at Cincinnati Children's Hospital Medical Center have figured out how cancer cells rewire themselves and, in turn, how to possibly overcome drug resistance.

This drug resistance may explain why some acute myeloid leukemia (AML) and other cancer patients suffer fatal relapses despite many improvements in leukemia outcomes over the years, according to a Children's news release.

"Overcoming resistance to therapy remains a holy grail of leukemia treatment," says Yi Zheng, Ph.D., director, experimental hematology and cancer biology at Cincinnati Children's. Zheng and his colleagues have now discovered a way to boost the effectiveness ofmTOR inhibitors, which prohibit unwanted cell proliferation.

"While the latest study is based on mouse models, building upon the findingspublished Dec. 21, 2020, in PNASeventually could improve outcomes for people with AML, and possibly other forms of cancer," a release says.

What Happens When Treatments Target mTOR?

"Using a novel mouse model, we have learned that deleting the mTOR gene prompts blood stem cells to multiply rapidly to open other pathways to continue producing new blood cells," says Zheng, the study's senior author. "We also found that leukemia cells use a similar response to continue multiplying despite mTOR-inhibiting treatments."

He says attacking mTOR essentially sets off alarms among hemopoietic stem cells (HSCs), which act like blood cell factories deep in bone marrow. Then the cells themselves produce a flood of new, re-wired blood cells. These re-wired stem cells, treated with mTOR inhibitors, can begin multiplying, rendering mTOR inhibitor drugs useless.

The co-authors say mTOR treatment resistance can be counteracted by inhibiting activity of the MNK, CDK9 or c-Myc genes. So-called BET inhibitors can act against c-Myc activity. Other inhibitors that are in clinical trials can act against CDK9.

Next Steps

Scientists at Cincinnati Childrens have already launched some of the research needed to prepare the combination therapies for in vivo test leading to human clinical trials, the news release says. That process will take time, but since mTOR inhibitors have been widely tested in clinical trials, investigators have a head start on exploring combination therapies.

Longer term, the findings may extend beyond AML, Zheng says, because mTOR has been a recognized target in most human cancers, including solid tumors like brain tumors.

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New Combination Therapy Tested By Children's May Offer Hope For Leukemia Patients - WVXU

Ashley Cain says over 80,000 people registered for stem cell donation in 48 hours after appeal to save baby – The Sun

ASHLEY Cain has revealed more than 80,000 have people joined the stem cell register after he pleaded for the public's help to save his baby daughter's life.

Little Azaylia was diagnosed with one of the rarest forms of leukaemia, AML [Acute Myeloid Leukaemia] , last month and needs a stem cell transplant to beat the disease.

7

Ashley, 30, called upon his fans to help him and his partner Safiyya Vorajee find a donor - along with the charitable organisations DKMS and Anthony Nolan - for the four-month-old tot.

In a new interview, Ashley and Safiyya have spoken for the first time at their shock at the overwhelming amount of support they received and opened up about the turmoil they're going through as they watch their baby daughter fight for her life.

Former footballer Ashley said: "When Azaylia needed a donor the amount of people who came together straight away to order test kits, do the tests and then send them back, was crazy.

7

"The DKMS and Anthony Nolan probably get around 30,000 to 40,000 registers a year. We got 80,000 people in a single weekend.

"It's now topping 100,000. And not only are they helping Azaylia, they are helping the thousands of people who also need donors.

"Social media can be such a cruel and cynical place at times but this has made me realise how beautiful it can be and how beautiful the people using it can be.

"For that support we will be forever grateful."

Ashley and Safiyya are currently living in a hotel next to Birmingham Children's Hospital to ensure they can be with their daughter around the clock.

Because of Covid-19 restrictions the couple can not be with their baby daughter together so spend 24 hours a day with her on rotation so they can both spend equal amounts of time with her.

7

When they first discovered Azaylia was sick, Ashley said the couple were warned to expect the worst.

He explained: "When Azaylia first got diagnosed it looked really bleak.

"Me and you as normal people would have a white cell count of five. Someone with leukaemia, even an adult, would have a white cell count of 40.

"Azaylia had a white cell count of 200. Plus tumours in her lungs, kidneys and stomach.

"I am strong but having that news was something I never thought I would have to go through. It broke me. I was a broken man."

7

Azaylia has since undergone two rounds of chemotherapy and is responding well to treatment.

However she will need a life-saving transplant in order to beat the disease once and for all.

Ashley added: "Its very rare to have leukaemia in babys as young as Azaylia, she is the only baby on the ward.

7

"And she also has AML, the most aggressive type of leukaemia, which is even rarer.

"And what is even rarer again is the fact that she had tumours on her stomach, her lungs and her kidneys. And that her white blood cell count was so high.

"Realistically for her to have even got to this point is an absolute miracle."

Ashley and Safiyya also wanted to speak publicly to warn other parents about the signs to look out for after doctors repeatedly misdiagnosed Azaylia.

Ashley said: "We had back and forth to the doctors over the course of four weeks. She had cold type symptoms and we got told she had a blocked nose. At points we were pleading with the doctors to let us come in because we knew something wasnt right.

"Then we were told she had colic and then they told us she had constipation. We did all the things to treat that and then we noticed the mottling."

Going back to the beginning, Safiyya continued: There was an occasion four weeks after Azaylia was born when there was red spotting in her nappy.

7

I went to the doctors and they told me to keep an eye on it. Then a little while after she had a really bloated stomach. I called up the doctor and then I took them in for her first course of injections.

Prior to her having her six week injection the doctor gave her a once over. I told the doctor about her stomach and that her chest was really heavy, it sounded like her chest was rattling it was like she couldnt breathe properly.

Her eyes were gunking up too, to the point where they were really swollen. It was making her face then swollen.

The tummy was so hard, it was like a hard ball, obviously now that was all the tumours. They gave her laxatives to try and sort it out, they gave us colic mixture, they gave us a spray for her nose

To know a doctor has felt over all the symptoms that were there, and there were two-three-four-five doctors we saw. The doctor I sent the picture of the mottling to was an on call doctor and he was the one who said take her immediately to A and E.

7

The couple now credit Azaylia for giving them the strength to continue their appeal for donors.

Ashley added: We call Azaylia little lion, she has the face of an angel and the heart of a lion.

It is personally inspiring every day for us to see her sheer strength. Her waking up smiling every day, no matter what she is going through, gives us strength.

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We also have to thank Birmingham Childrens hospital. We heard a lot about them before and everything we had heard was right.

From the nurses to the cleaners to the doctors, everyone goes the extra mile. They do incredible work but they also make you feel so at home.

Its those little touches and the extra effort they put into helping you which they dont get paid for. They all go the extra mile. To everyone on ward 18, they are just incredible.

If you want to help, you can join the register here.

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Ashley Cain says over 80,000 people registered for stem cell donation in 48 hours after appeal to save baby - The Sun

Rand Paul, Ron Johnson, and the race to the 2020 bottom – MSNBC

The competition has been fierce, and the competitors have spent months running neck and neck. But in the end, either Sen. Rand Paul (R-Ky.) or Sen. Ron Johnson (R-Ky.) will do the most damage to their reputation in 2020.

To be sure, the Kentucky Republican took the early lead in the race. In early March, as the nation started coming to grips with the coronavirus crisis, Congress approved a modest $8.3 billion emergency bill to respond to the public-health emergency. The bipartisan measure passed the Senate 96 to 1 -- and Sen. Rand Paul (R-Ky.) was the lone opponent.

But like any true competitor, the Wisconsin Republican fought back, making clear that Paul wasn't the only one who could look foolish. Indeed, later in March, Johnson blasted pandemic mitigation efforts as an "overreaction."

Back and forth they went. In May, Rand Paul publicly clashed with Dr. Anthony Fauci for no reason while insisting that New York is in New England. The same month, Ron Johnson suggested independent inspectors general should be subservient to Donald Trump.

Over the summer, after Rand Paul held up a bipartisan anti-lynching bill, Ron Johnson went after Lt. Col. Alexander Vindman, a decorated American war hero. The Kentuckian used his office to question epidemiological expertise, while the Wisconsinite used his office to chase anti-Biden conspiracy theories before Election Day.

But once the fall arrived, the self-defeating competition to destroy their reputation reached an entirely new level.

Rand Paul pretended Joe Biden didn't really win the 2020 presidential win, as Ron Johnson held a Senate hearing to blast "bureaucrats" for not making hydroxychloroquine more available. When Johnson held a separate hearing to undermine public confidence in the election results, Paul went further than most, telling the public that the 2020 election "in many ways was stolen."

Ron Johnson appeared to be inching ahead with a second hearing indulging his anti-science impulses, but Rand Paul fought back, taking a stand against a bill to protect judges from attackers. Johnson tried to take the lead by blocking a bipartisan measure on increased direct aid during the pandemic, but Paul stayed in the fight, denouncing increased voting in Georgia.

Last night, only six senators rejected a bipartisan compromise on economic relief and government funding, but since Johnson and Paul were both part of the sextet, neither could claim an advantage.

But shortly before the vote, the Kentucky Republican shared a few thoughts with a CNN reporter about the COVID-19 crisis.

"It's this political correctness of submission, submission, submission. Everybody's got to submit, going to walk around like a drone and wear a mask, and yet there's no real evidence of this working."

In reality, of course, the CDC has pointed to plenty of evidence that masks reduce the spread of the virus. What's more, mitigation efforts during a pandemic are not "political correctness," and it's profoundly foolish -- and potentially dangerous -- to argue otherwise.

There are only nine days remaining in the year. The ball's in your court, Ron Johnson.

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Rand Paul, Ron Johnson, and the race to the 2020 bottom - MSNBC

Why Im glad AOC and Mike Pence skipped ahead in the vaccine line – The Independent

Of all the strange bedfellows this political season has wrought, there are perhaps none so strange as Representative Ilhan Omar of The Squad and Senator Rand Paul, son of libertarian godfather Ron Paul. The two were united for one brief, bizarre moment this week in their criticism of Representative Alexandria Ocasio-Cortez and other lawmakers for jumping the vaccine line to get the inoculation on camera.

The criticism came directly after a chorus of outcry following Iowa Senator Joni Ernst, Vice President Mike Pence, and other Republican leaders choice to also get vaccinated publicly ahead of the line a choice that seemed especially galling considering their months of Trumpian Covid denialism.

The argument that lawmakers should not be able to put themselves ahead of healthcare workers, nursing home residents, the elderly, those with pre-existing conditions, and other essential workers is indeed compelling. But I would argue that these politicians using their influence to bolster trust in the vaccine does more to save lives than if they had waited until it was their turn with the rest of their cohort. And this goes for Republicans as well as Democrats.

Even while the pandemic continues to ravage through communities, public trust in the Covid-19 vaccine is low, especially among certain demographics. Overall, only 60 percent of Americans said they would definitely or probably get the vaccine, according to a recent Pew Research study, while the other 40 percent said they would probably or definitely not get the vaccine. But these statistics are not evenly represented among the populace.

Fewer than half of Black Americans said they would definitely or probably get the vaccine, even though Black people have been hospitalized or died due to the pandemic at greatly disproportionate rates. But Black communities have good reason to distrust the medical establishment, which has a long history of racism and dehumanization which continues to this day. Ocasio-Cortez, who represents a diverse district in New York City and wields tremendous influence with Democrats across the country, has the power to strengthen faith in the vaccine by volunteering to go first. When Ocasio-Cortez livestreamed her vaccination on her Instagram she said, Just like wearing a mask, I'd never advise you to do something I wasn't willing to do myself.

On Twitter, Rep. Omar stated, We are not more important than frontline workers, teachers etc. who are making sacrifices everyday. Which is why I wont take it. People who need it most should get it. Senator Paul took a direct shot at Rep. Ocasio-Cortez in his own tweet, in which he stated it would be inappropriate for him to receive the vaccine ahead of frontline healthcare workers or others who needed it, since he had already had the virus. Same goes for AOC or any young healthy person. They should be among last, not first, he added.

The Congresswoman replied: Gee, maybe if the GOP hadnt spent so much time undermining public faith in science, masks, and COVID itself, I wouldnt have to weigh the potential misinformation consequences of what would happen if leaders urged people to take a new vaccine that we werent taking ourselves!

Frankly, this is where I am in this debate.

According to the aforementioned Pew survey, over 60 percent of people who say they are likely to get the vaccine still do not want to get the vaccine first. This sentiment is part of the reason public inoculations are so powerful. For the skeptical, watching their legislator get the shot first may not Im more important than you as much as it says I volunteer to be the guinea pig.

It should also not be forgotten that among the vaccine-skeptical are those who should be first in line, including older Americans and even healthcare workers. Its possible that by putting themselves ahead, Ocasio-Cortez and Ernst will encourage more of these people to get the vaccine than otherwise would be comfortable doing so.

Another demographic disproportionately likely to mistrust the coronavirus vaccine is conservatives, who have been taught to minimize and dismiss the dangers of the pandemic by a Republican establishment that, yes, includes Ernst herself. Compounding this, an alarming number of conservatives believe at least in part in the many conspiracy theories swirling around the internet, among them a belief that the vaccine will implant a microchip in their bodies masterminded by Bill Gates. These communities are unlikely to be swayed by Ocasio-Cortez, but they could be moved by Ernst and other Republican leaders they respect.

Ernst got immediate backlash when she tweeted that she received the first dose of the vaccine in Iowa. Considering how much she has done over the past year to undermine faith in science and medicine, such a tweet feels to many like a punch in the jaw. But she also tweeted: I encourage all Iowans and Americans to do the same when their time comes. Thanks to Operation Warp Speed and the tireless work of Americans across the country, we are one step closer to defeating this virus.

Including the word first in her tweet was certainly not an accident. Ernst was clearly saying what Ocasio-Cortez did, in her own way. At the very least she demonstrated that she would not encourage her constituents to take an action that she was not willing to take herself. The anti-authoritarian, anti-science, anti-medicine sentiment runs deep in todays GOP, so it is useful for prominent members of the right wing to set an example. Indeed, if it were only lawmakers on the left getting the vaccine and not those on the right, it would only fortify belief in some vast conspiracy on the part of the Democratic establishment. What would it say to the MAGA faithful, who earnestly believes the Democrats are out to control them by nefarious means, if Joe Biden got the vaccine but Mike Pence did not? If AOC, in seeking to reassure her constituents, got the vaccine but Ernst, continuing her dangerously anti-science line, did not?

We need everyone, on both sides of the aisle, to get vaccinated if it is medically possible for them to do so in order to live in a world safe from Covid. If Ernst is willing to take steps to encourage faith in the vaccine, to undo some of the damage she herself has caused, then I heartily approve.

Perhaps this is too kind a reading of Ernsts tweet, and maybe she was acting out of self-interest and self-importance. But her motivations matter less at this point than her influence does.

Either way, this is a net good.

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Why Im glad AOC and Mike Pence skipped ahead in the vaccine line - The Independent

You’re only warned once: Ron Paul gets YouTube caution as an episode of his show censored for misinformation – RT

Former US presidential candidate and libertarian icon Ron Paul was censored by YouTube on Tuesday and threatened with even more sanctions on his account in the case of further violations.

Paul announced on Twitter that the Big Tech company had pulled an episode of the Ron Paul Liberty Report and issued a warning that any more violations will result in a temporary ban to put up more programs.

The episode was a news report on a Trump rally, Paul explained, calling the move very disturbing and blatant censorship.

The removed episode, which was published in November, was titled, Fire Fauci! Trump Rally Explodes Over Coronavirus Doom and Gloomer, a reference to White House Coronavirus Task Force member Dr. Anthony Fauci, and was accused by YouTube of spreading medical misinformation.

Your content was removed due to a violation of our Community Guidelines, YouTube declared, before informing Paul, You're only warned once and this warning will remain on your channel. The platform added that further sanctions against Paul could include a ban on him being able to upload new videos.

Though the full episode is now removed from YouTube, a teaser remains on Twitter.

YouTube which is owned by Google parent company Alphabet Inc. revealed earlier that it was banning videos which contain misinformation about Covid-19 spread, treatment and vaccines, as well as content that disputes health authorities' guidance on self-isolation or social distancing.

Think your friends would be interested? Share this story!

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You're only warned once: Ron Paul gets YouTube caution as an episode of his show censored for misinformation - RT

Red And Blue States: It’s Time For A Multistate Solution – OpEd – Eurasia Review

By James Ketler*

Far from being a unitive force, powerful, centralized government only serves to pit blocs of the electorate against each other. Division grows in lockstep with the ceaseless expansion of federal power, and the 2020 presidential election was a mere symptom of how heated that division has become. How much worse can it get? That remains to be seen. After Joe Bidens contested presidential win, the country may have to break apart into multiple independent political units if it is to avert further social disintegration.

To win elections, candidates must pander to the lowest common political denominator; i.e., they must promise to expand wide-reaching projects like social security, public healthcare, economic stimulus, and the military. In fact, candidates are incentivized tooutpromiseone anotherand when in powerto follow through on carrying out at least some of those promises in the interest of reelection. The mass-democratic structure lubricates this process, as costs are distributed across the entire population and thus become more or less hidden.Thats led to a constant, creeping growth in government power, behind which Republicans and Democrats almost always form a united front. As Tom Woodssays: No matter whoyou vote for, you always wind up getting John McCain.Within that statist unity, however, exist the seeds of electoral division.

Old, widely accepted government programs are used by politicians as a springboard for new, more expansive powers. Consider, for instance, the Green New Deal; it could only have been seriously proposed because of the broad-based support the New Deal programs have today. Each new law, regulation, bureau, and program is like a brickon top of which many others can be laid. Government seldom abrogates any of its power, tending instead towards constantly expanding it. That raises the stakes higher and higher with each successive election, with the winning party taking office with more power than ever before.

Centrally, as vote seekers, candidates must always work to demonize the opposition and distance themselves from them. To safeguard their own interests, voters must factionalize behind one candidate or the other, often coming to develop a deep, politico-cultural affinity with their choice, though they may only be the lesser of two evils.This drives a sharp wedge down the center of the political spectrum, pushing both sides further and further apart. As competing ideologies vie for control of the system, smaller and more amicable politico-cultural disputes thus become the faultlines of national fractionation. Many nuanced opinions are pounded into the ground and replaced, instead, by the Republican-Democrat binary. These two sides look at politics with irreconcilable politico-cultural presuppositions, driving each sideas both fight for control of the same systemto hate the other.

Once one party seizes control of the federal apparatus, it tries to solidify support from independents and moderates, while also working to punish its political rivals. From the enlightened, liberal principles that originally drove its adoption in the West, democracy has melted and deformedas it was always inevitably bound tointo an arena of open-faced realpolitik. Both parties seek to win by any means necessary, and the losers must always accept the results of the electionthat is, have the will of the majority imposed upon them. Its a system that neither side can consistently accept and that bothfor the good of the peoplemust agree to reject.

Nearly eight in tenRepublican voters agree that this years presidential election was rigged against President Trump through the perpetration of widespread voter fraud. Bidens win was, as they see it, afait accomplipredetermined before the first vote was cast. The legitimacy of the past few elections have been widely contested, moreover, as with, for instance, the Democrats accusations of Russian interference in 2016. After years of investigations and hearings, at least, those accusations were proven false, but this time around, further inquiry into the Republicans claims of voter fraud have been blocked by the mainstream media and the Washington establishment. With just cause, therefore, Trump loyalists have grasped at every legal recourse they can find in hopes that something will stick. But the bid to overturn the election was, from its inception, a long shot. On January 20, the 74 million Americans who voted for Trump will be forced under the yoke of a Biden presidency, which will only serve to turn up the heat in the country even more.

Nevertheless, Joe Biden has continuously tried to position himself as a moral leader who will unite the nation. In his November 7victory address, he said, I will govern as an American president. Ill work as hard for those who didnt vote for me as those who did. Does anyone, though, actually believe that? Bidens politics have differed over the years, but its clear that his 2020 agenda is by far further to the left than that of any other president in American history. At his side is Kamala Harris, who was rated themost progressive senatorin all of Congress last year. How can anyone pretend to imagine that the next administration will be at all unifying? Better yet, how can anyone thinkanymodern presidency will bring America together? Since 2016, the Democratic Party has freely embraced the tenets of socialism and radical progressive politics, while the rise of Trump helped fuel the growth of a new America First nationalist populism in the Republican Party. In just the past four years, the two parties have aggressively shifted away from each other and towardtheir ideological fringes. Moving forward, that split will likely only widen further.

On the campaign trail, Biden identified himself as a transition candidate for a deeper, more radical leftism coming down the line. First, the likes of Kamala Harris will take the reins of the country; then, AOC and the Squad.The Constitution-bashing, history-flipping platform of these soon-to-be party leaders will only exacerbate left-right tensions even furtheras they deal thecoup de grceto Americas founding principles. On the conservative side,Trump insidershave already pointed to the possibility of the outgoing president staging acomeback campaignin2024. And if he doesnt run himself, itll be one of his children, or his closest allies in Congressperhaps Tom Cotton or Matt Gaetz. The Trump brand looks like its here to stay in the Republican Party, and, if it is, it will continue to focus on carrying out the MAGA agenda. In fact, after four years of Biden, the Trump camp may be more energized than ever before. As the national consciousness continues to fork apart all the more diametrically, friends and neighbors will becomein the affairs of state, at leastever more bitter enemies, and the dream of a united US will fall further out of reach.

With that in mind, we must ask: Why should America be a single country at all? The states have for years already been working tonullifyfederal legislation on guns, drugs, healthcare, immigration, the environment, and police militarization. Why hold the states together in a union whose diktats they each want to escape? That steady resistance is unlikely to do anything but grow. Last month, after one of Bidenstop covid policy advisorscalled for a national lockdown, more than a dozenRepublican governorsexpressed their refusal to comply. How much more will it take before states decide to just walk away entirely?

Secession would give states full sovereignty over their own affairs, so that voters could live under policies more friendly and suitable to their own local and regional interests. There would no longer be a system of national politics, through which voters control and domineer others hundreds of miles away. From the very earliest years of the republic, secession was considered a viablepossibility. The United States was not considered a single, monolithic blob, as it often is today, but rather a voluntary confederation of free and independent statesassociated for the preservation of the common good. If the political tides turned and the Union ceased to be beneficial to its constituent parts, each was free to leave it. In 1816, Thomas Jeffersonmade this clear: [I]f any state in the union will declare that it prefers separation.I have no hesitation in saying let us separate. I would rather the states should withdraw, which are for unlimited commerce & war, and confederate with those alone which are for peace & agriculture.

Though the public perception of secession has been radically altered since the Civil War, Americas founding principles respect the right of every state to leave the Union. At this point, thestatesreassertion of that right has been long overdue. Secession isnowthe only way for the millions of tired and fed-up Americans to protect their interests against federal tyranny. Without it, nothing else can prevent the eventual breakdown of the social order, which is looming in the countrys future.

Just this past summer, far-left looters clashed violently with right-wing groups and police in city streets across the nation from Portland to Kenosha. Some of the postelection Stop the Steal rallies have themselves led todangerous confrontations, including stabbings in Washington, DC, and a shooting in Washington State. Indeed, apoll from Septemberrevealed that around 20 percentof voters in general would eagerly support the use of violence against their political opponents. Although the pivotal spark may have not yet arrived, the scaffolding for potential civil disaster is already in place. When the last straw breaks, will America spiral into chaos and insurrection, or will cooler heads agree to peaceful separation?

The idea of secession is, thankfully, neither alien nor farfetched to voters. In fact, widespread calls for secession have already been made in response to recent presidential elections. After Obamas reelection, the White Houses We the People initiative wasinundatedby petitions from all fifty states to be granted the right of unilateral secession. When Trump was elected, Democrats inOregonandCaliforniaorganized seriousmass secessionist movements that almost led to both states holding referenda on the topic. With each new election, the politico-cultural divide in America grows deeper and a national breakup looks all the more alluring. The impending Biden presidency may be the drop that spills the bucket.

Apollfrom Hofstra University this past September found that 44 percentof Republican respondents were open to the possibility of seceding if Joe Biden was elected. For millions of Trump voters, self-determination is an essential component to preserving their families, finances, and ways of life. Even Rush Limbaughthe king of conservative talk radiorecentlyponderedwhether, without secession, right-wing ideals can ever truly win again. If some Republican-majority states managed to leave the Union, that might mean lower taxes, fewer regulations, the repeal of gun laws, a new gold standard, school choice, abortion bans, and a more free healthcare market across the board. As independent states, they may discover that Trumpian politics doesnt actually represent them after all and instead forge paths more in line with their own local traditions. At last, political diversity would be allowed to emerge and flourish in these smaller, decentralized states, keeping the government more homegrown and orienting politics more towardthe interests of the people.

Whats most promising is that a few recent murmurings of secession have actually come from GOP lawmakers. After the election, Price Wallace, a state congressman from Mississippi,expressed his interestin secession,followed byCongressman Randy Weber, who succeeded Ron Paul for Texass fourteenth congressional district seat. Webers secessionist endorsement helped generate attention for the Texas Nationalist Movement (or Texit), including a sudden spike in the groups membership registrations. Weeks later, Texas state congressman Kyle Biedermannannouncedthat when the Texas House resumes session in January, hell introduce a bill to allow a popular referendum on the question of secession. Seemingly in support of Biedermanns proposal, the chairman of the Texas Republican Party, Allen West, thencommented, Perhaps law-abiding states should bond together and form a union of states that will abide by the constitution.Evidently, state legislators are entertaining the notion, many with considerable interest.

America may be on the brink of a secessionist moment,and if it is, the time to dismount the surly tiger of big government is now. Like dominoes, the process need only begin with one single state and many more will surely follow. After everything, thats the only real solution left for Americashaking hands, splitting up, and staying friends from afar, for clearly the country has already split apart in heart, mind, and soul, and at lastthis internal reality must be reflected in the legal reality.

*About the author: James Ketler is a high school student living in Massachusetts with his brother, sister, and parents. He became interested in libertarianism in 2015after hearing about Rand Pauls presidential campaign and followed the rabbit hole straight down to Mises and Rothbard. When hes able to find the time, James loves to study and write about liberty, ethics, history, and economics.

Source: This article was published by the MISES Institute

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Red And Blue States: It's Time For A Multistate Solution - OpEd - Eurasia Review

Letters to the editor, Dec. 18, 2020 – Idaho Press-Tribune

Disgrace

President Trump is a disgrace to himself and to our country.

When someone demands allegiance to himself, it sounds like he wants to be a dictator, or emperor.

I pledge allegiance to the flag of the United States of America, and to the Republic for which it stands.. President Trump demands allegiance to himself from all Republicans.

It seems our president would like to be like his two Bromance Buddies Putin and Un, who he has stated they love each other. What a bunch of bull. If anything, they may have advised him in how to take over total control of our country.

I respect the office of the President, but I do not believe Trump has any respect for himself or for our country. He is fully self-serving, in my opinion. Why else would he state he has the right to pardon himself? Obviously, he has done something that needs a pardon.

He has derided anyone who will not blindly follow him. He called our military veterans, many who have given their lives for this country and its citizens, LOSERS, SUCKERS!.

Completely disgraceful.

The Republican party is his now his lap dog, doing what he tells them to do, and if not, he threatens them with a TWEET. How truly weak and self-absorbed. Way more than we can comprehend, I am afraid.

Thank goodness his reign is almost over. He is pulling our country and the Republican party down to depths we may not be able to overcome.

Hugh Massie, Boise

Our Governor, and elected representatives, made an egregious mistake by filing in the U.S. Supreme Court, a Brief supporting the State of Texas to attack other States election processes, despite the vehement strong objection of their own Attorney, Lawrence Wasden the Idaho Attorney General. As the Idaho Attorney notified the Governor and the representatives, the State of Idaho is a sovereign state within the conglomeration named the United States of America. As a sovereign state, we as Idahoans have preserved and protected our States rights, such as our water in the State of Idaho. For many decades, California and Arizona and Las Vegas have set their sights on diverting Snake River water to supplement the Colorado River, which has been drying up for many years. If the U.S. Supreme Court had agreed with our elected officials in permitting the Trump lawsuit to proceed attacking other States, I would estimate that within months or years the States of California, Arizona and Nevada would have filed a counter lawsuit against the State of Idaho to divert Snake River water to the southwestern states to quench their never ending thirst. Basically, the southwestern states would have argued: Idaho, if the U.S. Supreme Court now says that you can meddle into the sovereign state affairs of Pennsylvania and other states, then we are going to meddle into your state affairs with Snake River water. Thank God the U.S. Supreme Court told the State of Texas and Idahos Governor and Idahos elected officials that they were flat wrong, because if the U.S. Supreme Court decided otherwise, get ready for the draining of the water from the Snake River with a viaduct headed to the Colorado River reservoirs near Las Vegas.

John Schroeder, Boise

Recent articles about Covid-19 suggest contacting the CDC for further information. Why?

President Kennedys nephew, Robert Kennedy, Jr., of Childrens Health Defense, calls the CDC a cesspool of corruption, and a snake pit of Big Pharma lies.

After CDC whistleblower Dr. William Thompson gave Congressman Bill Posey (R-FL) mountains of documentation about vaccine research fraud at the CDC, Posey pleaded, unsuccessfully, with Congress to open an investigation into CDC corruption.

Kennedy says Congress--as well as state legislatures--is bought by Big Pharma.

He is warning about todays coup detat by...this global public health cartel. See childrenshealthdefense.org.

In an open letter to Pres. Trump (available online), Archbishop Carlo Maria Vigano warns of the pandering by religious leaders and heads of nations to this suicide of the West, to this health dictatorship: (T)he fundamental rights of citizens and believers are denied in the name of a health emergency that is revealing itself...as instrumental to the establishment of an inhuman faceless tyranny.

Some Covid-19 vaccines being developed are, like many other diabolical vaccines, produced with aborted fetal cell lines, exposing vaccination recipients to aborted fetal DNA. See Children of God for Life, cogforlife.org.

US Supreme Court Justice Samuel Alitos recent comments before the Federalist Society warned that pandemic restrictions are threatening individual liberty, including religious liberty.

In a weekly update last month from Ron Paul Liberty Report, On Coronavirus, We Must Not Allow Politics to Dictate Science, former Congressman Ron Paul--a physician--mentioned the recent publication of two studies which challenge what the media has established as conventional wisdom about (Covid-19).

The first study found that wearing masks did little if anything to control the spread of the virus. The second found asymptomatic persons who have tested positive for Covid-19 do not pass on the infection to others.

Violet Fuller, Mackay

Im confused by Wayne Hoffmans justification for taking a PPP loan for the Idaho Freedom Foundation. The SBA website states, The Paycheck Protection Program is a loan designed to provide a direct incentive for small businesses to keep their workers on the payroll.

Wayne stated that Taking out a loan was the only course of action to protect my organization and its employees in uncertain times. What he did not tell us is how IFF is impacted by COVID-19 to justify the loan. I am on the board of a non-profit that relies heavily on admission revenue for its budget. Obviously, it is very much impacted by lockdown restrictions, so it clearly needed a PPP loan. I cannot see how IFF has a similar situation. Without more information it looks like the IFF saw an opportunity for a handout and took it knowing full well that even though it is a loan the IFF will almost certainly not have to pay it back.

This episode got me to thinking why should I listen to what Wayne Hoffman is saying anyway? I figured he must be former elected official or a high-level manager of government agency or successful businessperson or something like that. So, to find out I went to LinkedIn to check out his resume. I was surprised to find that there is no evidence that he has ever been in a position where he led a team during tough times or had to make tough decisions. He looks more like the guy sitting in the bleachers throwing bombs on the field. Hardly worth paying any attention to.

Steven Simpson, Boise

Two millennia and some years ago, a babe was borne in Bethlehem, and laid in a manger. The Almighty gave unto us a great gift of hope and love. In due time, those gifts laid a path before us that allowed curiosity and dreams to enlighten the world. Ideas of every persuasion, scientific and social, brought us out of the darkness. None have been more blessed than we Americans.

The genesis of the world saving bottled brilliance, vaccines from Pfizer and others, harkens to that birth. And it will soon be delivered to each corner of this Union and far beyond. Its possibility rests upon the genius of a few, the dreams and hard work of many, and the shared curiosity of generations. This Christmas season all humanity once again has received a great and wonderful gift. Let us rejoice and be glad. Soon, the light will shine again and bells will ring from sea to shining sea. And as we rejoice, for the sake of future generations, let us rededicate ourselves to the founding principles of this Nation. The ideals of life, liberty and the pursuit of happiness equally shared and respected by every man, woman, and child remains an idea and beacon like no other. It can be our gift to one and all.

Dan Bridges, Boise

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Why is Governor Little requiring the Idaho education department to decrease their budget by $99 million when we have $600 million in the rainy- day fund? The result of this decision burdens Idaho teachers by not providing them with an increase in salary that they deserve. Our teacher heroes- working despite unprecedented stress- go to class every day risking their health and work extra hours to ensure the virtual portion of our childrens education is valuable. Once again -through the actions of our elected officials- our teachers are made to feel as though their careers and their families are less important than maintaining a huge state savings account.

Idaho is dead last in the country for student spending. Why are we not investing in Idahos future? This treatment of teachers discourages students from entering the teaching profession and creates an even greater shortage of teachers in the future. Governor Little wants to keep Idaho kids in Idaho after school. Well, this is not a winning strategy for that goal. Education funding is a high return investment: future higher tax dollars are the result of better educated Idaho kids who stay in Idaho.

Shelley Cooper, Boise

During the last governors election I cast my vote for Gov Little as I thought his experience and desire to help Idahos education system rise from the lowest ranks and his promise for fiscal responsibility would appeal to this voter. And while you have done well in some areas, after reading todays article in how you support the Texas lawsuit to overturn the vote in swing states, you Governor Little have lost my support. You have now joined others in chipping away at democracy and your non belief in the fairness of an election without evidence. Was it peer pressure? Did Donald threaten to withhold funds from your state? You have embarrassed yourself in the eyes of many. But maybe its the minority who refuse to wear masks, and your inability to get tough from a state level (for fear of repercussions) on the virus that are the constituents you truly are serving as they are sure to go along with your support of this frivolous lawsuit. So next time your flying over our state in your helicopter, know that below, you have let down and lost support of this Idahoan.

Bryan Gerecke, Eagle

Its encouraging to see at least one of our elected officials honoring their pledge to our constitution. Thank you A.G. Wasden for choosing integrity over expediency.

Bill Killen, Boise

I am a customer. Michael Forsberg and his addled notion of liberty do not speak for me. Wearing a mask is no more burdensome than wearing a shirt and shoes in the store. Keep up the good work.

Louisa Evers, Nampa

The 2020 presidential election is over. Donald Trump was defeated and Joe Biden is Americas president-elect.

Given this outcome, instead of calling for unity and a peaceful transition of power Trump and his rabid followers continue to dispute the results with little credible evidence to support their beliefs. Melissa Carone....really? While all Americans have the right of freedom of speech the manner many have chosen to express this right has been both divisive and hateful. This is the real threat to America, as no good can come on a foundation supported in this manner. We have to be better.

Unfortunately too, we are seeing similar displays of unrest and civil disobedience on the local front in Idaho. Given the right to air grievances in peaceful protest, many Idahoans instead have chosen to do otherwise. We have recently witnessed where numerous public gatherings seeking open testimony and civil discourse instead were met with aggressive confrontations and disruptions of public proceedings. Often groups with the names of the Idaho Freedom Foundation, Stop the Steal (Peoples Rights) and followers of Ammon Bundy were responsible for the abhorrent behavior displayed. Idahos own Lt. Governor Janice McGeachin has irresponsibly followed suite. Instead of working alongside Governor Little in one united front on issues she has chosen instead buck him at almost every turn. In obvious early campaigning to unseat Little as Governor in a few years her tactics are both reprehensible and in disdain. After finally ridding Idaho of its reputation as the home of Richard Butler and the Aryan Nations, we are now looking at being the state with an equally unfortunate legacy. Come on Idaho, we are better.

Dave Pisarski, Eagle

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Letters to the editor, Dec. 18, 2020 - Idaho Press-Tribune

Local golf league results and upcoming events around Polk – The Ledger

Results from golf league play around Polk County through Dec. 21 with format, date, event and winners by flight or class in alphabetical order.

Big Cypress 18-Hole Ladies, Revert One Hole to Par on Each Nine, Dec. 15: First Flight - Jane Bryant 68, Donna Short and Irene Letourneau tied at 70; Kathi Wagner and Jennifer Renaud tied at 71, Kay Hink and Terri Traggio tied at 72; Third - Pat Frank 65, Carol O'Neil 68, Gail Hanus 69. Closest to pin: Donna Short 10-20 HDCP; Kay Hink 21 plus.

Big Cypress Men's Thursday, Low Gross Low Net, Dec. 17: First Flight Gross - Joe Freeman 84, Steve Sanders 86, Keith Roberts 86, Net - Gary Bryant 77, John Patterson 78; Second Gross - Jeff Rahill6 79, Mike Klein 83, Net - Eddie Lane 72, Ron Doner 75, Harm Oldenkamp 75; Third Gross - Ross Moen 91, Bart Tokas 92, Net - Bob Chapman 73, Dale Smith 78. Closest to pin: No. 5 - Steve Sanders 0-11, Jeff Rahilly 12-15, Ross Moen 16 plus; No. 8 - Gary Bryant 0-11, Earl Hawn 12-15; No. 13 - Dave Turner 0-11, Mike Klein 12-15, Eddie Lane 16 plus; No. 15 - Gary Bryant 0-11, Harm Oldenkamp 12-15, Jeff Rahilly 16 plus.

Big Cypress North Stars, T and S Holes, Net, Dec. 16: First Flight - Rose Mary Allen and Allison Letourneau tied at 32, Paula Baer 33; Second - Carol Kauth 28, Gail Hanus and Barb Helding tied at 30; Third - Charlotte Kiefer 28, Joyce Putnam 29.

Cleveland Heights Men's Wednesday, Dec. 16: Green Tee - Ratley Meese plus 3, Gil Besse plus 2, Dave Konopnicki even; Yellow - Les Hettinger plus 5, Frank Shinn plus 3, Woody Blades plus 2. Closest to pin: Green - Ratley Meese.

Cleveland Heights Tuesday Men's, Draw and Quota Points, Dec. 15: Gil Besse/Steve Criss/Keith Wightman/Gary Vandergriff plus 10, Gary Cornell/Bennie Boutwell/Ken Rohrer/Wayne Cross plus 8, Wayne College/Mike Rickels/Bob Reichert/Clark DeGroat plus 7. Closest to pin: No. A2 - Keith Wightman; No. C8 - Walt Wilson. Best Over Quota: A - Dick Gebo and Gil Besse both at plus 5; B - Gary Cornell plus 6; C - Steve Criss plus 4.

Cleveland Heights Tuesday Women's, Ts and Fs, Dec. 15: First Flight - Marsha Mathews 36.0, Penny Stephens 38.5; Second - Chris Westlund 39.0, Barbara Schucht 39.5; Third - Diane Oneil 35, Vicki Fioravanti 38.5.

Cleveland Heights Weekend Women's, Quota Points, Dec. 20: First Flight - Vicki England plus 20, Shirley Kalck plus 10, Julie Alameda plus 2; Second - Vicki Fioravanti and Sue Cudaback tied at plus 21, Myrna Iosue plus 17, Chris Westlund plus 16.

Eaglebrooke Men's Early Morning Group, Score vs Average Score, Dec. 19: Keith Volkman/Mike Gilbert/Mark Neville minus 2.1, Mike King/Mark Grey/Kyle Thomas minus 2.0, Paul Meyer/John Tillis/Dave Conway plus 1.0; Team Quota Point, Dec. 20: Dave Conway/Mark Grey/Mike Gilbert/Jon Moore plus 15, Smith Patterson/Kyle Thomas/Tony Autorino plus 10, Richard Grant/Joe Whitfield/John Johnson plus 4.

Hamptons Couples, Two-Man Best Ball, Dec. 19: Bill Colclaser/Shirley Schell/Rob Nordsick/Angie Rotondo 88, Ron Weller/Connie Weller/Jean Thomas/Skip Muir 97, Scott MacGregor/Donna Richner/Rick Cook/Deb Weingard 99. Closest to pin: No. 5 - Deb Weingard; No. 13 - Scott MacGregor. Best Score: Deb Weingard 67; Joe DeBonis 68.

Hamptons Ladies 18-Hole, Stableford, Dec. 17: Sandy Hall plus 5, Shirley Schell plus 4, Judy Wheeler plus 3. Closest to pin: No. 7 - Sally Fiske; No. 13 - Sandy Hall.

Hamptons Men's, Net Stroke Play, Dec. 15: A Flight - Ron Davis 57 on a match of cards over Billy Stalilonis, Don Verhey 59 on a match of cards; B - Larry Baker 52, George Bradley 55, Bob Miller 58. Closest to pin: No. 8 - Terry Foster; No. 17 - Jim Carter.

Hamptons Sunday Duffers, Scramble, Dec. 20: Sally Fiske/Kathy Lilley/Dick Hansen minus 2, Terry Foster/Gregg Lilley/Judy Orioli plus 2.

Hamptons Wednesday Stableford, Dec. 16: Front plus 3 - Greg Stephens/Gregg Lilley/Bill Kelsey/Mike Ready; Back plus 9 - Terry Foster/Wayne Smithson/Ron Davis/Denny Sittler; Overall plus 12 - Greg Stephens/Gregg Lilley/Bill Kelsey/Mike Ready. Closest to pin: Front No. 2 - Bob Vollwerth; No. 5 - George Bradley; Back No. 11 - Mike Frain; No. 17 - Dick Weller. Best Score: Bill Spivey 66.

Lake Ashton Ladies 18-Holers, Two Person Team - Best Ball Gross, Best Ball Net, Dec. 15: First Flight Gross - Liz Leigh/Margie Dersham 78, Pat Amstutz/Deb Louder 79, Net - Deb Foulke/Janice Smith and Shearly Simpson/Jody Nesheim tied at 64; Second Gross - Lynne Abbott/Kathy Reed and Jan Kipp/Mary Ann Mentjes tied at 88, Net - Chris Hunziker/Gwen Novak 61, Jane Fuller/Sandy Alfano 65; Combo Gross - Mary DeCroes/Sue Kurtz 85, Diane Holman/Marie Clauser 88, Net - Carol Williams/Cecily Harmon 59, Carole Ferrieri/Dana Cunningham 64.

Lake Ashton Ladies Niners, Scramble, Dec. 15: Colleen Smith/Janet Mutz/Sharon Connell/Fern Leising 23.9, Wanda Mears/Joyce Candler/Vick Olesen and Linda Ford/Cathy Kapinus/Chris Neuner/Pat Chipak tied at 26, Laverne Anderson/Cindy Mendez/Cyndy Berry/Dawn Neigh 27.

Lake Ashton Men's, Pick Your 10 Best Holes, Dec. 16: Jay Ramahlo/Steve Kettels/Don Connors/Pat O'Neil 135, Rolly Geyer/Sal Tabone/Mike Krigelski/Terry Tressler 144, Jim Williams/Gerry Krogman/Mike Lavigna/Tom Williams 146.

Lake Bess Friday 3 p.m. Men's Scramble, Random Team Draw, Dec. 11: Doug Wilson/Dan Petry/Steve Tucker/Jimbo Stevens minus 6. Closest to pin: No. 3 - Henry Adams; No. 7 - Jake St. Louis. Random Team Draw, Dec. 18: Doug Wilson/Bob Gaskill/Russ Johnson/Damian Scott minus 7. Closest to pin: No. 3 - Ollen Melvin; No. 17 - Bob Gaskill.

Lake Bess Tuesday 3 p.m. Men's Scramble, Random Team Draw, Dec. 15: Ray Huggins/Steve Tucker/Henry Adams/Gene Depue minus 6. Closest to pin: No. 3 - Henry Adams; No. 7 - Mark Detrick.

Lakeland Elks Lodge 1291 Monday League, Wedgewood, Dec. 21: A Flight - Bob Kutsch plus 10, Lee Laborde plus 7, Jack Meister plus 6 on a match of cards; B - Mark Dillon plus 12, Fred Ellis plus 7, Pete Finstad plus 6. Closest to pin: No. 8 - Dave Norwine (50/50); No. 15 - Ed Wolfe.

Lakeland Men's Senior, Huntington Hills, Dec. 21: A Flight - Gary Terrell plus 2, Mike Frost plus 1; B - Joe Stevens plus 4, Mike Parillo plus 3; C - Al Hughes plus 8, Ed Scannell plus 6; D - Pete Casella plus 3, Dennis Vannoy minus 1 on a match of cards over Felix Bartotto and John Weber. Closest to pin: No. 3 - Joe Stevens; No. 11 - Dave Brown. Low Gross - Gary Terrell 75.

Polk County Women's, Christmas Tournament, Lake Wales Country Club, Team Quota Points, Dec. 14: Barbara Heddon/Marsha Mathews/Connie Minich/Christine Westlund plus 9, Janet Brown/Sue Wells/Brenda Johnston/Judy Bruce plus 7, Liz Leigh/Debbie Noel/Robbie Rowan/Vicki Fioravanti plus 6.

Sandpiper Women's, Dec. 15: Flight A - G. Clay 68, G. Emigh 73, K. Cline 76; B - J. Scesny 74, C. Jones 75 on a match of cards over S. Herring; C - H. Gillespie 74, S. Nusbaum 81, M. Crankshaw 85. Closest to pin: A - J. Curl; C - H. Gillespie.

Schalamar Creek Couples', One Best Ball on Par 5s, Two Best Balls on Par 4s, Three Best Balls on Par 3s, Dec. 16: First Flight - Greg Porter/Rita Porter/Bob Shoenfelt/Eleanor Shoenfelt and Clayt Liljequist/Linda Liljequist/David Kelter/Kathy Kelter tied at 125. Nine-Hole Flight - Tom Richards/Linda Richards/Dan Watters/Jeanne Watters and Gordon Claffey/JoAnne Claffey/Tom Fischer/J.R. Finkle tied at 59.

Schalamar Creek Ladies', Four-Person Scramble, Dec. 15: First Flight - Patty Lacross/Linda Richards/Carol Sutton/Barb McLaughlin 70, Linda Liljequist/Jennifer Keser/Alice Piechoski/Ginger Valentine 71, Sharon Chapman/Pat Atherton/Barb Mahar/Linda Bushong 72.

Schalamar Creek Men's, One Gross Plus One Net, Dec. 14: First Flight - Howard Basso/Arlan Atherton/Don Lowry/Ron Lloyd 133, Steve Scotia/Joe McElhenny/Chuck Raymond/Pat McGee 139, Jim Keser/Tim Lancaster/Rich Baxter/Ralph Rhamy, Greg Porter/Don Swint/Terry Phalen/Dennis Priewe and Glen Valentine/Skip Foster/David Peer/Tim Conrad all at 140.

Schalamar Creek Nine-Hole Men's,

BARTOW INDIVIDUAL POINTS, Wednesdays, nine holes, make up your own foursome, $17 ($12 green fee and cart), pays all plus scores, night specials in the lounge. Call 863-533-9183.

CLEVELAND HEIGHTS MENS, tee times available 7:30-8:30 a.m. Wednesday through Monday and Friday, groups or individuals welcome, quota points with skins optional, eight to 10 groups now play. Call Paul Boeh at 863-738-4129.

CLEVELAND HEIGHTS TUESDAY WOMENS, every Tuesday, tee times start at 8:30 a.m. Call Shirley Kalck at 863-853-9566.

HAMPTONS TUESDAY MEN'S LEAGUE, accepting new players. Call 844-882-8157 for more information.

HUNTINGTON HILLS TWO-ASIDE, Saturdays, 18-Hole Points Quota. Check in by 8:15 a.m. Contact Terri White at 863-5594082 or eagle-2par@aol.com.

HUNTINGTON HILLS WHY WORRY WEDNESDAYS, Nine-Hole Quota Points, 5:15 p.m. shotgun start. Contact Terri White at 863-559-4082 or eagle-2par@aol.com.

LAKELAND MENS SENIOR GOLF, 7:30 a.m. shotgun starts, Mondays, play against golfers within your handicap. Call Dave Brown at 419-656-5747.

LPGA AMATEUR GOLF ASSOCIATION is looking for women and men to play in weekly Wednesday league and every other Saturday at various courses in the Winter Haven/Lakeland/Orlando and other areas. For more information, email Kathy Mannahan at pjacobs21@tampabay.rr.com.

POLO PARK MENS TUESDAY SCRAMBLE, 7:30 a.m. sign in. Random team draw. 18-Hole. For more information, call Polo Park Pro Shop at 863-424-3341.

POLO PARK MENS SATURDAY SCRAMBLE, 7:30 a.m. sign in. Random team draw. 18-Hole. For more information, call Polo Park Pro Shop at 863-424-3341.

RIDGE MENS THURSDAY QUOTA POINTS TOURNAMENTS, 7:30 a.m. tee time starts. Call Carroll Lasseter at 863-299-5350.

WEDGEWOOD THREE-MAN SCRAMBLE, nine holes; Tuesdays at 5 p.m.; call Marcus at 863-858-4451 by 2:30 p.m. to play.

WEDGEWOOD TWO-ASIDE GAME, 9 a.m. on Wednesdays and Fridays; 18-hole points game with skins and blind draw; call Marcus at 863-858-4451.

WEDGEWOOD MIXED CO-ED SCRAMBLE, 2 p.m. Thursdays. Call Marcus at 863-858-4451 by 1 p.m. to play.

E-mail results of local golf tournaments, aces and upcoming tournaments to mquinn@theledger.com; or mail to Golf News, Ledger Sports Department, P.O. Box 408, Lakeland, Fla., 33802. Include complete scores and league names. Deadline is Monday at 5 p.m.

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Local golf league results and upcoming events around Polk - The Ledger

Ronald Goeke | The Standard Newspaper – Waukon Standard

Ronald A. Goeke, 96, of Waukon died Monday, December 21, 2020 at Northgate Care Center in Waukon from complications of COVID-19. Private family graveside services will be held Saturday, December 26 at Waterville Lutheran Cemetery in Waterville with Pastor Kim Thacker officiating. In consideration of concerns regarding COVID-19, social distancing and wearing of a mask is required.

Cards may be sent to Wendy Ebner at 984 Ebner Drive, Lansing, IA 52151 or to Randy Goeke at 654 Dry Hollow Road, Waterville, IA 52170. Martin-Grau Funeral Home in Waukon is handling the arrangements.

Ronald Aaron Goeke was born March 21, 1924 in Waukon, the son of George and Gertrude (Shindoll) Goeke. He was raised on a farm in North Fork Hollow in rural Waukon, attended grade school at McCabe Jefferson #3 School and graduated from Waukon High School in 1942.

Ron was confirmed at Zion United Church of Christ in Waukon, where he sang in the choir. He left home at an early age, after his mother died, and worked for area farmers; Ron liked to tell stories of operating threshing machines at the age of 16. Ronald rode his motorcycle to Texas in the winters. June 16, 1951, he married Clarice Marie Tysland at the Waterville Lutheran Church, where he became a member and served on the church council.

Ron was a hard worker and held various jobs: hauling can and bulk milk, working for Purina Feeds and Meadowland Creamery, and doing maintenance work for Good Samaritan Center and Veterans Memorial Hospital, both in Waukon. He also farmed, raising horses and Ayrshire cattle. Later in life, he went to work for Design Homes in Prairie du Chien, WI, retiring at the age of 84.

In 2011, he moved to Southcrest Manor in Waukon and lived there until he moved to Northgate Care Center in Waukon in 2015. Ron enjoyed going to horse sales, coon hunting and pheasant hunting when he was younger.

His family was very important to him and he was very interested in his grandchildrens lives. Ron was a kind and gentle person; he was the best dad and grandpa anyone could have and his familys best friend. He will be greatly missed and he loved his family very much.

Survivors include his children: Wendy (Paul) Ebner of Lansing and Randy (Vicki) Goeke of Waterville; six grandchildren: Jacob Ebner, Andrew (Stephanee) Goeke, Troy (Esther) Pierce, Tony (Abigail) Pierce, Chris (Jason) Grady and Sandy Goeke; nine great-grandchildren: Gabriel Goeke, Hailey, Ahren, Rhett and Jase Grady, and Cai, Cortland, Abraham and Shepherd Pierce; a brother, Allen (Ella Mae) Goeke of Waukon; a sister, Karen Delatte of Madison, MS; and several nieces and nephews.

He is preceded in death by his parents; his wife, Clarice, who died in 1993; two sisters, Ruth Dotseth and Lorna Miller; a brother, Wesley Goeke; a sister-in-law, Carol Goeke; and three brothers-in-law, Vernon Miller, John Dotseth and Lawrence Tysland.

Online condolences may be left at http://www.martinfunerals.com.

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Ronald Goeke | The Standard Newspaper - Waukon Standard

Ron Conway, Zillow CEO agree to give away fortunes with Giving Pledge – Business Insider – Business Insider

A new round of billionaires has signed onto Bill Gates and Warren Buffett's Giving Pledge, whose signatories agree to give the majority of their fortunes away.

The new billionaires include Zillow cofounder and CEO Rich Barton as well as famed Silicon Valley "super angel" investor Ron Conway, according to the Giving Pledge's website. Early Facebook employee Jeff Rothschild, who has a net worth of $3.8 billion according to Forbes, and Blackstone CEO Stephen Schwartzman also signed this year. As Forbes estimates, the combined net worth of the new signatories sits at more than $40 billion.

The Giving Pledge was founded in 2010 by Bill and Melinda Gates and investor Warren Buffet as a "movement of philanthropists who commit to giving the majority of their wealth to philanthropy or charitable causes, either during their lifetimes or in their wills." Signatories must be bona fide billionaires.

It has since garnered the signatures of over 200 billionaires across the world, like Microsoft co-founder Paul Allen, Facebook CEO Mark Zuckerberg, and Salesforce CEO Marc Benioff.

But a 2020 report from the think tank Institute for Policy Studies found that the majority of the original signatories are now much richer than they were when they signed back in 2010, suggesting that they are making money faster than they are giving it away.

As Forbes notes, the pledge isn't binding, meaning Giving Pledge can't force those who sign to give their fortunes to charitable organizations. The Giving Pledge also doesn't oversee donations made by signatories.

Read more: Jeff Bezos is the first person ever to be worth $200 billion. This is how the Amazon CEO's immense wealth stacks up to the average US worker, the British monarchy, and entire countries' GDP.

Some billionaires have been criticized for not donating enough to charity organizations Amazon CEO Jeff Bezos has accumulated a net worth of more than $200 billion since first becoming a billionaire in 1997. He is the richest person in the world and the only American in the world's five richest that has not signed the Giving Pledge.

Bezos' ex-wife, Mackenzie Scott, signed the Giving Pledge in mid-2019 after her $38 billion divorce settlement. She has donated more than $4 billion over the last few months to more than 300 organizations to help people hit hard by pandemic-driven economic trouble.

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Ron Conway, Zillow CEO agree to give away fortunes with Giving Pledge - Business Insider - Business Insider