Rural Development Minister: Eid-Ul-Adha brings spiritual renewal – Loop News Trinidad and Tobago

Rural Development and Local Government Minister Kazim Hosein, a devout member of the Muslim community, has extended Eid Mubarak greetings to his brothers and sisters ofthe faith.

Hosein said having completed fasting on the day of Arafah, Muslims are reminded that the most significant prayer is that performed on this day where Prophet Mohammed recited: There is nothing that deserves to be worshipped in truth except Allah, He is Alone and has no partner, to Him belongs the dominion and to Him belongs all praise, and He is All-Powerful over all things.

He said for Muslims who are not performing Hajj, fasting on the day of Arafah rewards forgiveness for two years.

The Minister further explained that Eid-Ul-Adha is the greater of both Eids with the 10-day fast being more significant than that which occurs during the month of Ramadan.

One of the primary reasons for this is because Eid Ul-Adha commemorates Prophet Abrahams unyielding commitment to his faith, through his willingness to sacrifice his son Ismail. Before he could carry out the sacrifice, Allah recognized his act of devotion and intervened, providing a lamb as an offering to take Ismails place.

It also marks the end of the holy pilgrimage where billions of Muslims across the world would come together to give honour to the spirit of sacrifice.

Health precautions implemented to stem the spread of COVID-19 have unfortunately preventedthe annual pilgrimage making the Hajj impossible for many.

Notwithstanding this obstacle, my fellow brothers and sisters in Islam remain grateful for the opportunity to worship at our mosques in the company of our friends and families. Similar to last months Eid-ul-Fitr celebration, this sacred occasion teaches us that our sacrifices are always rewarded by Almighty Allah (swt).

Despite practitioners of Islam being unable to complete Hajj, Eid-Ul-Adha brought us both a physical and spiritual lesson in sacrifice. I truly believe that because of our discipline, sacrifice and faith in the Almighty, we were able to celebrate this observance in a more profound manner. COVID-19 has taught us that we as Muslims must continue to seek redemption, to forgive and be forgiven. It has also reminded us that every sacrifice that we make in our lives often leads to a greater reward.

Hosein said he has drawn closer to Allahover the past few months, with his appreaciation for his loved ones increasing exponentially. He said he also has a greater desire to continue helping those less fortunate in his community and his country by extension.

This experience has showed us the value of simple devotion, reminding us that sacrifice is a key aspect of not only spiritual development but also spiritual renewal.

On behalf of the Ministry of Rural Development and Local Government, I extend Eid-Ul-Adha greetings to ournational Muslim community at home and abroad, and wish for all citizens of our beloved nation peace, good health and prosperity for every day of your journey through life.

Originally posted here:

Rural Development Minister: Eid-Ul-Adha brings spiritual renewal - Loop News Trinidad and Tobago

Sparano Shares Progress Made in the Molecular Guided Management of Breast Cancer – OncLive

The advent of gene expression assays has provided predictive insight into chemotherapy benefit that can be combined with prognostic information yielded by gene expression profiling to better target patients with breast cancer who are at higher clinical risk for the use of adjuvant chemotherapy, according to Joseph A. Sparano, MD.

The notion of precision medicine in breast cancer is not a new concept; it dates back to the 1970s when we began using ER and PR protein expression initially by ligand-binding assay and then by immunohistochemistry to identify patients who would benefit from adjuvant endocrine therapy, said Sparano, a professor of medicine and womens health at Albert Einstein College of Medicine, in a presentation during the 19th AnnualInternational Congress on the Future of Breast Cancer West, a virtual program by Physician Education Resource (PER).1

We then entered the second generation using gene amplification for HER2/neu via FISH testing to identify women who could benefit from adjuvant trastuzumab (Herceptin), an anti-HER2based therapy, added Sparano. Fifteen years into the third generation [we use] gene expression profiles to guide the use of adjuvant chemotherapy and endocrine therapy. We're currently pretty far into the fourth generation of assays in terms of mutational profiling, which can identify individuals who could benefit from targeted therapies.

In his presentation, Sparano, who is also an associate chairman in the Department of Oncology at Montefiore Medical Center, provided insight into advances made with gene expression profiles, the clinical utility of available assays, as well as future directions in this area.

Gene expression profiles first emerged in the breast cancer paradigm about 15 years ago based on unsupervised analyses, which indicated that breast cancer was a heterogenous disease, that there were distinct subtypes, and that prognosis could vary by subtype, according to Sparano. The unsupervised work resulted in the PAM50 assay (Prosigna), which can be used to identify the distinct breast cancer subtypes that exist.

The next generation of gene expression assays were based on supervised analyses, which evaluated genes associated with a better or worse prognosis. This research led to the development of various prognostic assays, which included the 21-Gene recurrence score assay (Oncotype DX) and the 70-Gene signature test (MammaPrint), among others.

One important point is that theres a lack of concordance in the prognostic classification provided by these assays, said Sparano.

Prospective Validation

The first trial to show that a gene expression assay could provide independent prognostic information was the B14 trial, which included archival samples from a total of 668 patients with estrogen receptor (ER)positive, node-negative breast cancer who had received treatment with tamoxifen for 5 years.

Fifty-one percent of patients fell into the low-risk group, which was defined as a recurrence score (RS) of less than 18, 22% of patients were in the intermediate-risk group (RS of 18-30), and 27% were in the high-risk group (RS of 31 or greater). The 10-year risk of distant recurrence was 7%, 14%, and 31%, respectively, for each of these groups.2

Further data revealed a statistically significant association for RS that was independent of age and tumor size, said Sparano. As such, RS was not a surrogate marker for these other factors; it provided independent prognostic information.

Results from another study, referred to as B20, went on to demonstrate prediction of benefit with these assays.3 A total of 651 patients with ER-positive, node-negative breast cancer were randomized to receive tamoxifen or tamoxifen plus chemotherapy. For the entire cohort you see approximately a 4% improvement in distant relapse-free survival for patients who received chemotherapy, noted Sparano. However, there was a very large benefit for patients who had a RS of 31 or higher; the absolute benefit was in the range of about 25% in the group with the highest RS, suggesting that one can identify, using this assay, a subpopulation of patients who are deriving all of the benefit from chemotherapy.

The prospective TAILORx trial included women with hormone receptorpositive, HER2-negative, and axillary node-negative breast cancer and they were randomized to treatment based on their RS.

Of the 10,273 women enrolled on the trial, 1629 who had a low RS of 0 to 10, were assigned to receive endocrine therapy alone (arm A). Women with a high RS of 26 to 100 were assigned to endocrine therapy plus chemotherapy (arm D). Those in the midrange who had a RS of 11 to 25 were randomized to receive either endocrine therapy plus chemotherapy in the standard arm (arm C), versus endocrine therapy alone in the experimental arm (arm B).

The study had a noninferiority design with invasive disease-free survival (iDFS) as the primary end point, and full information is expected after 835 iDFS events were reported.

We modified the mid-range group for several reasons. The TAILORx population excluded HER2-positive disease and we know that the 21-gene assay includes a HER2 module that drives the RS up and is associated with a higher score, but we know that most HER2-positive tumors have a higher RS, explained Sparano.5 As such, if you use the assay in a HER2-negative population, youll have a different RS distribution.

Additionally, the RS assay is used selectively in practice in situations where there is therapeutic equipoise, which is typically intermediate-grade tumors that are 1 cm to 2 cm; this results in more tumors having a score in the mid-range group, according to Sparano. The trial really needed to be designed to address that group, he said.

Moreover, the RS range was adjusted to preserve prediction in the highest-risk group and minimize the potential for undertreatment in the low-risk group, Sparano added.

Initial data from the low-risk group showed that at 5 years, the rate of freedom from recurrence of breast cancer at a distant site was 99.3% (95% CI, 98.7%-99.6%).4 This information was subsequently integrated into the American Joint Committee on Cancers Cancer Staging Manual, noted Sparano.

After a median of 7.5 years, results from the intent-to-treat population (arms B and C) were released and showed that the primary end point for iDFS was met (HR, 1.08; 95% CI, 0.94-1.24; P = .26), demonstrating noninferiority of endocrine therapy compared with the standard.6 Endocrine therapy alone was also found to be noninferior to chemoendocrine therapy with regard to freedom of recurrence of breast cancer at a distant site (HR, 1.10; 95% CI, 0.85-1.41; P = .48).

Investigators then examined whether any patients with a mid-range score were still deriving benefit from the chemotherapy. No benefit was observed with regard to increasing tumor size or grade, but statistically significant chemotherapy treatment interactions were observed between age, RS, and chemotherapy benefit. Patients who had a higher RS and a higher clinical risk within this younger group seemed to derive benefit, explained Sparano.

At 9 years, in those with a RS of 16-20, a 1.6% absolute benefit from chemotherapy was observed versus a 6.5% absolute benefit in those with RS ranging from 21 to 25, added Sparano.

An exploratory analysis looking at the impact of age and menopausal status on chemotherapy benefit in patients with a RS ranging from 16 to 25 showed that there was no benefit in older women with an increasing score. However, curves began to separate for younger women with a RS of less than 25, noted Sparano.

When examining absolute differences in 9-year distant recurrence rates by chemotherapy use in women 50 years or younger with RS of 16 to 25 stratified by RS and clinical risk, investigators noted that the estimated absolute benefit of chemotherapy in women with a RS of 16 to 20 who were not stratified by clinical risk was +1.6%. The estimated absolute chemotherapy benefit stratified by clinical risk was -0.2% in those with low clinical risk (n = 671) and a RS between 16 and 20 and +6.5% in those with high clinical risk (n = 215).7

When looking at the impact of age on chemotherapy benefit, investigators observed that women who were closer to menopause, aged 46 to 50 years, experienced the greatest benefit. Interestingly, younger women really had no benefit, suggesting that some of the effect that was seen with chemotherapy in these younger patients who had higher RS might have been due to a castration effect, explained Sparano.

At 9 years, a 3% distant recurrence with endocrine therapy alone was observed in patients with an RS of 0 to 10 (arm A). An overall 5% distant recurrence rate was reported in those with an RS between 11 and 25 (arms B and C). Between arms B and C, a less than 1% difference was observed for all end points. In those with a RS between 26 and 100 (Arm D), a 13% distant recurrence was observed, despite chemotherapy plus endocrine treatment.

MINDACT

The MINDACT trial included 6,693 patients who were assigned to a clinical risk or a genomic risk. Patients who had discordance in their clinical and genomic risks were randomized to receive either no chemotherapy or chemotherapy.8 The primary end point of the trial was distant metastasis-free survival at 5 years for those with high clinical risk and low genomic risk without chemotherapy.

No effect with chemotherapy was observed in older women, but there was a 5% benefit from chemotherapy in younger women, which is very similar to what we saw in TAILORx, said Sparano.

The phase 3 Plan B trial used the Oncotype DX Recurrence Score to define a genomically low-risk subset of patients with clinically high-risk pN0-1 early breast cancer for adjuvant treatment with endocrine therapy alone. A total of 3198 patients were enrolled on the trial and chemotherapy was omitted in 86.1% of eligible patients with a RS of 11 or less.

At a median follow-up of 5 years, DFS in the patients treated with endocrine therapy alone who had a RS of 11 of less was 94% versus 94% in those with an RS between 12 and 25 and 84% in those with an RS of greater than 25 (P < .001). In patients who received chemotherapy, the 5-year overall survival was 99% versus 97% versus 93%, respectively (P < .001).

This provided a limited amount of level 1 evidence supporting the use of the Oncotype assay in patients with low-volume disease, noted Sparano.

Future Directions

With all of the data yielded thus far, it is clear that gene expression assays provide prognostic information, that the 21-gene assay offers predictive information, and that the 70-gene assay provides prognostic information, according to Sparano.

Its important to remember that these assays are not interchangeable, and theres a lack of concordance in risk classification which needs to be considered when deciding which assay to use and what to do with the information yielded, concluded Sparano. Future plans involve integration of the clinical and gene expression profile information to recalibrate existing tools in an effort to provide more refined information regarding prognosis as well as an estimation of chemotherapy benefit.

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Sparano Shares Progress Made in the Molecular Guided Management of Breast Cancer - OncLive

Stress-sensing Molecule May Be Potential Therapeutic Target in ALS – ALS News Today

A small molecule called microRNA-182-5p (miR1825p) is involved in the detection of cell stress and in the survival of motor neurons, the cells progressively lost in people inamyotrophic lateral sclerosis(ALS), a study in mice showed.

These findings shed light on the mechanisms behind ALS stress-associated nerve cell death and provide new potential therapeutic targets.

The study, MicroRNA1835p is stressinducible and protects neurons against cell death in amyotrophic lateral sclerosis, was published in the Journal of Cellular and Molecular Medicine.

MicroRNAs, or miRNAs, are small RNA molecules that target a specific genes messenger RNA (mRNA) the genetic blueprint derived from DNA and used as a template for protein production to prevent generation of that protein. A single miRNA can regulate several mRNAs.

Increasing evidence suggests that miRNAs dysregulation contributes to neurodegeneration in ALS patients, which may help toidentify new diagnostic biomarkers and develop new therapeutic approaches for ALS.

Notably, miRNAs were found to be involved in the detection and response to cell stressincluding oxidative stress, which promotes the toxic build-up of TDP-43 clumps, problems in mitochondria(the cells powerhouses), and nerve cell death in ALS.

Oxidative stress is an imbalance in the production of harmful molecules calledreactive oxygen speciesthat can lead to cell damage and death.

While problems in stress detection or response may contribute to nerve cell death in ALS, such underlying mechanisms remain largely unknown.

Researchers at West China Hospital of Sichuan University, in China, now have discovered that miR1825p, a microRNA known to be dysregulated in several cancers, is highly present in motor neurons nerve cells that control voluntary muscle movement and regulates stress-sensing mechanisms and cell death in a mouse model of ALS.

The team first found that while miR1825p was detected in several organs and tissues of healthy mice, its highest levels were present in the spinal cord, particularly in the region containing motor neurons.

The researchers then assessed whether miR1825p levels in the spinal cord were different between healthy mice and a mouse model of ALS.

Mice with ALS had significantly higher miR1825p levels in the pre-symptomatic and early symptomatic stages of the disease and significantly lower levels in the late stages, compared with healthy mice.

This drop in miR1825p levels in late ALS stages may be related to its characteristic, progressive loss of motor neurons, the researchers noted.

Database analyses identified a total of 399 potential genes targeted bymiR1825p, which were involved mainly in cell stress responses and cell death. Further tests in lab-grown mouse nerve cells, including motor neurons, showed that miR1825p was produced in response to several stress conditions associated with ALS.

These included oxidative stress, endoplasmic reticulum stress(a kind of stress response to defective protein production), andtumor necrosis factor (TNF) alpha, an inflammatory molecule.

Notably, blocking miR1825p in nerve cells under such stress conditions led to a drastic increase in cell death, while promoting higher-than-normal levels of miR1825p had a protective effect.

Further analysis revealed that miR1825p regulates nerve cell death by directly suppressing PDCD4 a critical protein in apoptosis, the natural process of programmed cell death and RIPK3 a wellknown regulator of necroptosis, a form of inflammatory cell death associated with motor neuron death in ALS.

These findings highlight that miR1835p is not only a stress sensor in motor neurons, but also an executive factor in neuron death programming, the researchers wrote, noting that it protects neurons against cell death under stress conditions.

Our study supplements current understanding of the mechanistic link between cell stress and death/survival, and provides novel targets for clinical interventions of ALS, the team wrote, adding that increasing the levels of miR1835p may potentially prevent motor neuron death in ALS.

Given that a previous study showed that white blood cells of Chinese ALS patients had significantly lower levels of miR1825p, compared with those of healthy people, miR1835p may have a systemic (body-wide) role in ALS, the researchers noted.

Marta Figueiredo holds a BSc in Biology and a MSc in Evolutionary and Developmental Biology from the University of Lisbon, Portugal. She is currently finishing her PhD in Biomedical Sciences at the University of Lisbon, where she focused her research on the role of several signalling pathways in thymus and parathyroid glands embryonic development.

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Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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Stress-sensing Molecule May Be Potential Therapeutic Target in ALS - ALS News Today

Electroceuticals/Bioelectric Medicine Market to Witness Tremendous Growth in Coming Years || Leading Players – BioElectronics Corporation, SetPoint…

Electroceuticals/Bioelectric Medicine Market

For in-depth understanding of market and competitive landscape, this Electroceuticals/Bioelectric Medicine Market research report provides a lot of parameters and detailed data about Healthcare industry. The report offers persistent knowledge and information of revolutionizing market landscape, what already exists in the market, future trends or what the market expects, the competitive environment, and strategies to plan to outshine the competitors. Various market related parameters considered in this Electroceuticals/Bioelectric Medicine Market research report helps businesses for better decision making.

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Market Analysis:Global Electroceuticals/Bioelectric Medicine Market

The electroceuticals/bioelectric medicine market accounted to USD 17.26 Billion in 2016 growing at a CAGR of 8.1% during the forecast period of 2017 to 2024. The upcoming market report contains data for historic years 2015, the base year of calculation is 2016 and the forecast period is 2017 to 2024.

Major Market Competitors:Global Electroceuticals/Bioelectric Medicine Market

Some of the major players operating inelectroceuticals/bioelectric medicine marketareMedtronic, Abbott, Boston Scientific Corporation, Cochlear Ltd., Livanova PLC, Sonova, BIOTRONIK SE & Co. KG, Nevro Corp., SECOND SIGHT, electroCore LLC, Synapse electroceutical Ltd., BioElectronics Corporation, SetPoint Medical, Inc., Bright Medical Ltd, GlaxoSmithKline Plc, EnteroMedics Inc., Alphabet Inc., The Medicines Company, FRV ELECTROCEUTICALS and Valencia Technologies Corporationamong others.

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Market Definition:Global Electroceuticals/Bioelectric Medicine Market

Bioelectric medicine combines bioengineering, molecular medicine, and neuroscience to develop nerve-stimulating technologies for the parameter of biological processes during treatment of disease. Increasingincidences of chronic diseases such as cardiac and neurological disorders leads to the market growth. Thus, there is high demand for advanced bioelectric medicine for the treatment of these chronic disorders.

Major market drivers and restraints:

Market Segmentation:Global Electroceuticals/Bioelectric Medicine Market

The electroceuticals/bioelectric medicine market is segmented by product into implantable cardioverter defibrillators, cardiac pacemakers, spinal cord stimulators, cochlear implants, deep brain stimulators, transcutaneous electrical nerve stimulators, vagus nerve stimulators, sacral nerve stimulators and retinal implants.

By type of device the market is segmented into implantable electroceutical devices and non-invasive electroceutical devices.

By application the market is further segmented into cardiac pacemakers and implantable cardioverter defibrillators market, spinal cord stimulators market, cochlear implants market, deep brain stimulators market, transcutaneous electrical nerve stimulators market, vagus nerve stimulators market, sacral nerve stimulators market, retinal implants market and others.

Cardiac pacemakers and implantable cardioverter defibrillators marketis sub segmented by application into arrhythmia.Spinal cord stimulators (SCS) market is sub segmented by application into chronic pain, failed back syndrome (FBSS) and ischemia.Cochlear implants market is sub segmented by application into sensorineural hearing loss.Deep brain stimulators (DBS) market is sub segmented by application into Parkinsons disease, tremor, depression and other. Transcutaneous electrical nerve stimulators (TENS) market is sub segmented by application into treatment-resistant depression and other.Vagusnerve stimulators market is sub segmented by application into epilepsy and other.Sacral nerve stimulators (SNS) market is sub segmented by application into urinary incontinence and fecal incontinence.Retinalimplants market is sub segmented by application into retinitis pigmentosa.Other market is sub segmented by application into gastroparesis obesity, depression, migraine and spinal cord injury.

By end user the market is segmented into hospitals, clinics, research institutes and individual users.

On the basis of geography, electroceuticals/bioelectric medicine market report covers data points for 28 countries across multiple geographies such as North America & South America, Europe, Asia-Pacific, and Middle East & Africa. Some of the major countries covered in this report are U.S., Canada, Germany, France, U.K., Netherlands, Switzerland, Turkey, Russia, China, India, South Korea, Japan, Australia, Singapore, Saudi Arabia, South Africa, andBrazil among others. In 2017, North America is expected to dominate the market.

Competitive Analysis:Global Electroceuticals/Bioelectric Medicine Market

The electroceuticals/bioelectric medicine market is highly fragmented and is based on new product launches and clinical results of products. Hence the major players have used various strategies such as new product launches, clinical trials, market initiatives, high expense on research and development, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of electroceuticals/bioelectric medicine market for global, Europe, North America, Asia Pacific and South America.

Research Methodology:Global Electroceuticals/Bioelectric Medicine Market

Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analyzed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more pleaseRequest an analyst callor drop down your enquiry.

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Electroceuticals/Bioelectric Medicine Market to Witness Tremendous Growth in Coming Years || Leading Players - BioElectronics Corporation, SetPoint...

Digong forgot to mention the cure for Covid-19 The Manila Times – The Manila Times

ONE of the highlights in President Rodrigo Digong Dutertes fifth State of the Nation Address (SONA) was his proposal to Congress to revive the death penalty through lethal injection.

The death penalty law was passed during the term of President Fidel Ramos, but was scrapped by President Gloria Macapagal Arroyo, who gave in to pressure from the Catholic Church.

The death penalty could decrease the commission of heinous crimes.

Digong said drug offenses would be covered by his proposed death penalty.

But how about rape with homicide, rape of a minor, murder, robbery with homicide and large-scale estafa?

How about law enforcers who commit grave offenses using their badges as a shield? Among the serious crimes by law enforcers is planting evidence on innocent citizens.

How about government officials who coddle big-time criminals?

The above-cited offenses should have been included by Digong as punishable by lethal injection.

If Congress considers the Presidents proposal to restore the death penalty, it should include the other heinous crimes mentioned above.

* * *

Congress should not listen to bleeding hearts like Amnesty International since they refuse to see the real crime situation in the Philippines.

Bleeding hearts were not able to stop the death penalty in many countries, including some states in the United States.

Why should they stop our country from restoring the death penalty?

* * *

I was expecting the President to announce the discovery by Filipino doctors of a cure for seriously ill coronavirus disease 2019 (Covid-19) patients in the SONA.

The citizenry, cowering in fear of the dreaded illness, would have appreciated the Presidents speech more if he had included the medical breakthrough.

The medical breakthrough was announced by Palace spokesman Harry Roque Jr. in a virtual press conference in Malacaang several days before the SONA.

However, the story was buried in the inside pages of major newspapers, a treatment it did not deserve.

The discovery of the cure for Covid-19 was made by scientists at The Medical City hospital through its Institute of Molecular Medicine stem cell program.

Stem cells taken from the blood of preserved umbilical cords worked their magic on six patients about to be intubated through intravenous injections.

I wrote about the medical breakthrough in my column last Tuesday, July 28.

For those who missed that column, you may want to read it at the Manilatimes.net.

* * *

A big supply of umbilical cords would bring down the cost of the stem cell therapy for Covid-19.

Tens of thousands of women give birth in the country and the umbilical cords of the newborns are thrown away.

The possible sources of umbilical cords are government hospitals and paanakan (maternity) centers.

The Philippines is a big manufacturer of babies.

Proof is that for a small country, our population has ballooned to 110 million.

To digress, I was a medical representative (detailman) in 1973 and one of the hospitals in Metro Manila that I was assigned to cover was the Fabella Memorial Hospital, a maternity hospital, in Sta. Cruz, Manila.

As I was fixing the promotional medicines I would give to some doctors at Fabella, I heard the screams of pain by a woman about to give birth at the delivery room.

Armando, Armando! P****g i*a mo! the woman was shouting, apparently referring to her husband.

I heard the nurse or midwife tell the woman, Tumigil ka nga diyan! Huwag mong sisihin ang asawa mo. Taun-taon nandito ka (Shut up! Dont blame your husband. Youre here every year).

See what I mean by the country being a manufacturing center of babies?

* * *

Another highlight of the Presidents SONA was his plan to establish the Coconut Farmers Trust Fund.

That part of Digongs speech was near to my heart as I come from Davao Oriental, a province where the main livelihood of the people is harvesting coconuts and turning them into copra.

Coconut farmers are the poorest in the country.

It was not so before, say, in the 1960s, when the price of copra was very high and coconut farmers in my hometown Manay could send their children to very good schools in Davao City and elsewhere.

But the price of copra in the world market is now very low and Filipino coconut farmers have become impoverished as a result.

However, the dying coconut industry might soon come to life again and the farmers could be rich once more.

An American friend of mine, Matt Grecsec, has invented a machine that converts coconut husk into hardwood for construction materials.

Grecsec, whos from Florida and married to a Filipina, has been coming to the Philippines looking for a place to set up his plant to make hardwood out of coconut husk.

Coconut husk is thrown away by farmers who make copra.

Grecsec has been meeting with Agriculture Secretary William Dar who has expressed enthusiasm for his project.

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Digong forgot to mention the cure for Covid-19 The Manila Times - The Manila Times

Coronavirus testing hits a wall: Where do we go from here? – MedTech Dive

This story is part of a MedTech Dive series examining the impact of the COVID-19 pandemic on the medtech industry, published six months after the U.S. declared a public health emergency. You can find the other stories here.

When the U.S. declared a public health emergency on the final day of January in response to the coronavirus pandemic, it was clear the nation lacked the diagnostic capabilities to combat the rapidly spreading infection.

Six months later, COVID-19 cases are surging in the South and West. But despite new tests coming online from companies such as Abbott, BD, Roche and Thermo Fisher and a capacity ramp-up by commercial labs like LabCorp and Quest, the nation is still only able to muster 4.5 million tests per week.

Thats a far cry from the 30 million tests weekly needed within the next three months to safely reopen communities and state economies, and keep them open, according to the Rockefeller Foundation, which this month proposed a National COVID-19 Testing & Tracing Action Planto address the shortfall.

Echoing many other public health experts, the plans authors warn the U.S. is losing its battle against COVID-19 and that testing is the only way to avert further devastation until a vaccine or effective therapeutics are widely available.

The Rockefeller authors contend that within the next three months to contain the pandemic, what's required is access to diagnostic testing for Americans with symptoms at least 5 million tests per week with turnaround times of less than 48 hours as well as 25 million fast, inexpensive screening tests for asymptomatic people.

The national focus should not just be on bringing more COVID-19 diagnostic tests to the market, but significantly boosting onsite and home testing of people not showing symptoms,the foundation contends.

Abbott Labs, whose point-of-care ID Now platform was one of the first molecular tests to get an FDA emergency use OK,is also betting that large scale rapid testing is the next chapter of the pandemic response.

With the phased easing of shelter-in-place restrictions, were entering a new phase where continued testing of symptomatic patients will start to overlap with broader surveillance testing of asymptomatic patients in order to better track, understand and contain the spread of the virus until we have broad vaccine availability, Abbott CEO Robert Ford told investors on a July 16 second-quarter earnings call.

While the FDA has cleared more than 150 molecular tests, only two antigen tests, sold by BD and Quidel, have emergency use authorization.Abbott is now working on its own antigen test.

Unlike polymerase chain reaction tests, which detect viral genetic material, antigen testing is designed to determine if a sample contains proteins found on the surface of the coronavirus, enabling delivery of results in minutes rather than days.

Some public health experts are advocating a broad push using the antigen tests, especially as LabCorpand Quest struggle to keep up with increased demand for molecular diagnostics as U.S. coronavirus cases rise.

Whereas molecular tests are typically highly accurate and usually do not need to be repeated, FDA has recommended that negative results from antigen tests should be confirmed with a molecular test. In particular, the agency has warned that antigen tests are not able to definitively rule out active COVID-19 infection.

"Thats why when the FDA approved those assays, they approved it under the remark that if its negative you have to reconfirm it with a PCR assay. And obviously most are negative, so you have to do a lot of PCR assays following that,"Roche Diagnostics CEO Thomas Schinecker told investors on a Thursday earnings call.

However, Mara Aspinall, a biomedical diagnostics professor at Arizona State Universitys College of Health Solutions, makes the case that the U.S. cannot break the chain of transmission if the coronavirus outpaces public health efforts.

Whats needed is a paradigm shift from exquisitely accurate-but-slow tests to fast-and-good enough to quarantine," she said.Slow and accurate works for clinical management, but this virus is a sprinter not a marathoner.We need fast and frequent tests just to keep up."

That approach has been endorsed by top U.S. health officials, including National Institutes of Health Director Francis Collins and federal testing czar Brett Giroir.

Earlier this month, FDA granted emergency use authorization to BDs rapid, point-of-care coronavirus antigen test, making it only the second such diagnostic to receive a nod from the regulatory agency.

A Quidel product, which claimed the antigen category's first EUAin May, delivers results in 15 minutes.BD's test, which runs on the company's widely used Veritor Plus System, also delivers results in 15 minutes.

What appears to set Quidel's antigen-based diagnostic apart from BD's is its accuracy. Quidel on July 17 sharednew data showing its COVID-19 antigen test has 96.7%sensitivity which is comparable to the sensitivity rates of PCR tests, according to the company.

"Lower sensitivity had been an argument we have heard over and over about why antigen testing was not going to be used and this should help put that to bed," William Blair analysts wrote in a July 20 note to investors.

The analysts contend Quidel's latest data on its antigen test puts it "on par with many of the molecular tests on the market" as well as "above the performance of the other antigen test on the market from BD."

By comparison, BD's antigen test has 84% sensitivity. Asked if BD is looking to update its clinical performance data, a spokesperson told MedTech Dive they are not aware of any plans to do so.

As for Abbott,CEO Ford declined during the July 16 earnings call to provide specifics in terms of timing and when the diagnostic might be available. He did say antigen tests offer an interesting value proposition compared to molecular testing.Ford emphasized that Abbotts goal is to produce a reliable antigen test thats easy to use and, equally important, is affordable.

I think thats the critical aspect here. If we want to get to more mass screening, more mass volume, these tests need to be more affordable, and one of the ways you do that is you remove the restriction on the [lab-based] instrument, or requiring an instrument, he told investors.

When it comes to diagnostic testing, easy, fast, and cheap is also what the Rockefeller Foundation is advocating to bring tests to the U.S. market at a national scale needed to effectively respond to the pandemic. The organization envisions point-of-careantigen tests costing $5 to $10 per test, with same-day test results for schools and workplaces, and even faster turnaround times for mobile testing in communities.

Today the country conducts almost zero such [screening] tests, and we need at least 25 million per week for schools, health facilities, and essential workers to function safely, wrote Rajiv Shah, president of the Rockefeller Foundation, in the organizations proposed national testing plan.

The U.S. will need at least another $75 billion in federal funding for testing to reach the plans goal of 30 million tests per week by October, including at least 25 million fast, inexpensive antigen tests for asymptomatic Americans, according to the Rockefeller Foundation.

The call for more money for testing comes as a debate continues on Capitol Hill over what the next coronavirus relief bill should appropriate.The HEROES Act passed by House Democrats in May providesan additional $75 billion for testing but Senate Republicans are likely to come up with their own legislation with less funding.

Senate Republicans are considering much lower figures for testing as President Donald Trump has resisted more testing on a false claim that it leads to more cases.

The Rockefeller Foundation also wants the administration to invoke the Defense Production Act, or similar federal program, to jumpstart producing and distributing mass quantities of fast, low-cost antigen tests. The administration reluctantly used the Korean War-era law earlier in the pandemic to force industry's hand in producing ventilators.

Fueled by soaring demand for molecular diagnostic testing across the country,particularly in the South, Southwest and West, current test processing delays experienced by the two largest commercial labs are hamstringing Americas COVID-19 response.

Quest reportedJuly 20 that non-priority patients face average wait times for their test results of seven or more days, while "priority 1" patients, or those considered critical, are now having to wait an average of more than two days for results. A company spokesperson told MedTech Dive the company is "planning to issue updated numbers" on Monday afternoon."Otherwise, the July numbers are the most up to date," she said.

By comparison, LabCorp reported Sunday its average wait time for results was two to three days from specimen pickup, down from three to five days last week, and that turnaround times are "faster" for hospitalized patients.

Nonetheless, slower than 48-hour turnaround times for test results are making contact tracing ineffective. In fact, a studypublished on July 16 in The Lancet found that test results need to be delivered within a day of a person developing symptoms for contact tracing to be effective in reducing transmission of the coronavirus.

As LabCorp and Quest are having a hard time meeting hotspot-driven demand in a timely fashion,the Trump administration is hoping rapid point-of-care tests from Abbott, BD and Quidel can alleviate the pressure.

Giroir, lead for federal COVID-19 testing efforts, has touted the ability of antigen-based tests from BD and Quidel, as well as Abbott's ID Now molecular test, to be performed outside of lab settings in minutes rather than days.

The testing czar acknowledged Sunday that test results are taking too long. "The delays that most people talk about are at the large commercial labs that perform about half the testing in the country,"Giroir said on CNNs State of the Union, while estimating that the average turnaround is about 4.27 days."I would be happy with point-of-care testing everywhere. We are not there yet,"he added.

NIH director Collins has echoed those sentiments, commenting that wait times for test results are "too long" currently and rapid antigen-based diagnostics could be the answer.

Writing in a New England Journal of Medicine article published Wednesday, Collins and his co-authors noted that while PCR tests are highly sensitive they require a large amount of lab space, complex equipment, regulatory approvals for lab operations, as well as skilled technicians to run them.In addition, they said with this type of testing there is the need to transport specimens to a central lab that leads to further delays.

"For this reason, low-complexity molecular diagnostic point-of-care tests with rapid turnaround have substantial practical advantages," wrote Collins and others, who pointed out that antigen testing can provide quick results "similar to the way pregnancy tests operate." They noted that a number of manufacturers are currently developing them.

A Quest spokesperson told MedTech Dive that "there remains value in molecular diagnostic testing." At the same time, they said the company is "exploring the option to launch its own antigen test" but declined to disclose any additional details. LabCorp currently has no plans for antigen testing, according to a company spokesperson.

Quest's future plans for an antigen test aside, the company is taking other approaches to molecular testing in an attempt to maximize capacity.On July 18 it announced its PCR test, which first got emergency use authorization by FDA in March, was granted an agency EUA for sample pooling, a method meant to screen more people using fewer testing resources.

LabCorp announcedSaturday that it also received an EUA from FDA authorizing diagnostic testing of groups of individuals for active COVID-19 infections using pooled testing.

Sample pooling, in the case of Quest's molecular test, allows specimens collected from four individuals to be tested in a pool or batch using one test, rather than running each in its own test. LabCorp's pooled testing method involves testing up to five samples at once.

Quest acknowledges the inherent limitation of sample pooling:it's only an efficient way to evaluate patients in regions or populations with low rates of disease. Quest Chief Medical Officer Jay Wohlgemuth said in a statement that while sample pooling will help expand testing capacity it is not a "magic bullet" and "testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity."

While LabCorp believes pooled testing can increase its overall testing capacity, the company concedes that specimens with low viral loads may not be detected in sample pools due to decreased sensitivity and that the method may be used for populations at low risk, when testing demand exceeds capacity, or when reagents are in short supply.

However, the Rockefeller Foundation argues that despite testing advancements such as sample pooling,the commercial labs cannot come close to fulfilling the nations screening test needs.

Lab tests arent convenient, simple, or inexpensive enough to use at the scale needed, the report says,calling for a ramp-up in antigen testing in schools, offices and beyond.

The Rockefeller Foundation also believes it is critical for the U.S. to look beyond commercial laboratories such as LabCorp and Quest that are overwhelmed and tap the testing resources of other underutilized labs, recruiting academic and other labs.

However, time is of the essence, according to Shah."We will soon enter a new cold and flu season with potentially 100 million cases of flu-like symptoms that stand to overwhelm our current testing capacity."

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Coronavirus testing hits a wall: Where do we go from here? - MedTech Dive

miRagen, Investigators from Goethe University and University Hospital Frankfurt and Servier Publish MRG-110 Phase 1 Pharmacodynamic Biomarker Data in…

FRANKFURT, Germany and BOULDER, Colo., July 28, 2020 (GLOBE NEWSWIRE) -- Goethe University, University Hospital Frankfurt and miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announcedthat preliminary results from a Phase 1 trial detailing the pharmacodynamic activity of MRG-110 has been published in the peer-reviewed journal Nucleic Acid Therapeutics.

We are pleased to have these Phase 1 mechanism of action results for MRG-110 published in Nucleic Acid Therapeutics, said William S. Marshall, Ph.D., President and CEO of miRagen Therapeutics, Inc. These data show that a single systemic dose of MRG-110 reduced detectable miR-92a levels in the peripheral blood of humans and led to the regulation of several well established miR-92a target genes.

The preliminary characterization of MRG-110 pharmacodynamic activity in the peripheral blood of humans provides important insight into the development of potential blood borne mechanistic biomarkers for miR-92a inhibition, added Prof. Dr. Stefanie Dimmeler, Director of the Institute for Cardiovascular Regeneration at the Center for Molecular Medicine, Goethe University Frankfurt. We believe these data provide the basis for further development of readily monitorable biomarkers that can be employed in future clinical trials.

The article, titled Efficiency and Target Derepression of Anti-miR-92a: Results of a First in Human Study, reports mechanistic results from a single ascending dose, double-blind, placebo-controlled, randomized Phase 1 clinical trial. The trial was a study where MRG-110 was administered systemically by intravenous dosing. miR-92a levels were measured in whole blood, circulating endothelial cells, and circulating extracellular vesicles before and after MRG-110 administration. miR-92a levels were found to be significantly reduced in all three of the sample types tested. Importantly, two miR-92a target genes were derepressed after treatment, indicating the intended mechanism of action of MRG-110 in normal healthy volunteers. These data may identify a strategy for measuring pharmacodynamic activity of MRG-110 in peripheral blood in future clinical trials. This would allow for monitoring the intended mechanism of action in blood samples during the conduct of clinical trials in patients, thereby providing an enhanced degree of confidence that the product candidate is affecting the biological pathway that is intended.

Work reported in the article was the result of a collaboration between Goethe University, University Hospital Frankfurt, miRagen Therapeutics and Les Laboratories Servier. Financial support for the studies was also provided by the German Centre for Cardiovascular Research (DZHK).

About miRagen Therapeutics, Inc.miRagen Therapeutics, Inc. is a clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapies with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. miRagen has three clinical stage product candidates, cobomarsen, remlarsen, and MRG-110. miRagens clinical product candidate for the treatment of certain cancers, cobomarsen, is an inhibitor of miR-155, which is found at abnormally high levels in malignant cells of several blood cancers. miRagens clinical product candidate for the treatment of pathological fibrosis, remlarsen, is a replacement for miR-29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including cutaneous, cardiac, renal, hepatic, pulmonary and ocular fibrosis, as well as in systemic sclerosis. MRG-110, an inhibitor of miR-92, is miRagens product candidate for the treatment of heart failure and other ischemic disease. In addition to these programs, miRagen is developing a pipeline of preclinical product candidates. The goal of miRagens translational medicine strategy is to progress rapidly to first-in-human studies once it has established the pharmacokinetics, pharmacodynamic, safety, and manufacturability of the product candidate in preclinical studies. For more information, please visitwww.miragen.com. For information on clinical trials please visitwww.clinicaltrials.gov.

About the University Hospital FrankfurtThe University Hospital Frankfurt, founded in 1914, is one of the leading academic hospitals in Germany. It offers its patients optimal medical care in 32 medical clinics / institutes. University hospital and faculty of Medicine together operate a total of 20 research institutes. The close connection to research ensures patients the prompt implementation of new knowledge in therapeutic practice. Around 1,500 inpatient as well as day clinic beds are available. Numerous institutes are dedicated to medical-scientific specialized services. Annually we take care of 51,000 inpatients and 227,000 outpatients. The University Hospital Frankfurt has special interdisciplinary competence amongst others in the fields of neuroscience, oncology and cardiovascular medicine. As a specialist for organ and bone marrow transplantation, dialysis and cardiac surgery, the clinic takes a special task of supra-regional medical care. Over 4,500 employees (full-time positions) take care of the patients around the clock.

About the German Centre for Cardiovascular Research (DZHK)The German Centre for Cardiovascular Research unites high-ranking scientists from all over Germany. It was founded in 2011 with the aim of bundling expertise in cardiovascular research and making it more effective so that research results can be transferred more quickly into clinical application. 1800 researchers from seven partner sites and 30 partner institutions, including university hospitals and non-university research institutions, are involved in the DZHK.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, including statements regarding miRagens strategy, anticipated clinical development milestones, prospects, plans and objectives of management are forward-looking statements. The words believe, may, will, estimate, continue, anticipate, intend, plan, expect, predict, potential, opportunity, goals, or should, and similar expressions are intended to identify forward-looking statements. Such statements are based on managements current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation: that miRagen has incurred losses since its inception, and anticipates that it will continue to incur significant losses for the foreseeable future; future financing activities may cause miRagen to restrict its operations or require it to relinquish rights; miRagen may fail to demonstrate safety and efficacy of its product candidates; miRagens product candidates are unproven and may never lead to marketable products; miRagens product candidates are based on a relatively novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all; miRagens product candidates may cause undesirable side effects or have other properties that could delay or prevent the regulatory approval; and the results of miRagens clinical trials to date are not sufficient to show safety and efficacy of miRagens product candidates and may not be indicative of future clinical trial results.

miRagen has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under the heading Risk Factors in miRagens Annual Report on Form 10-K and subsequent periodic and current reports filed with the Securities and Exchange Commission. Moreover, miRagen operates in a very competitive and rapidly changing environment. New risks emerge from time to time.

It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. miRagen undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

Investor Relations Contact:Dan FerryManaging DirectorLifeSci Advisors617-430-7576daniel@lifesciadvisors.com

Corresponding Author: Prof. Dr. Stefanie DimmelerInstitute for Cardiovascular RegenerationCentre of Molecular MedicineGoethe University FrankfurtTheodor Stern Kai 7 60590 Frankfurt; GermanyPhone: +49-69-6301-5158 Fax: +49-69-6301-83462dimmeler@em.uni-frankfurt.de

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AGC to Complete the Acquisition of MolMed on July 31, 2020 – PRNewswire

Cell and gene therapy is an innovative and rapidly growing therapeutic field that aims to treat diseases that do not have adequate treatments to date. Approximately 1,000 clinical trials are underway worldwide, with some products receiving market authorization in the last few years and approximately 50 new therapies expected to be authorized by 2030. Thanks to its two commercially authorized facilities, MolMed offers GMP services for the development and production of cell and gene therapies. MolMed brings deep experience and expertise in providing development and GMP manufacturing services for viral vectors and genetically modified cells, from the preclinical phase through commercial demand.

"While we work hard to take care of each other and our customers during this very challenging and uncertain time, it's also important that we ensure the continued growth of our company," says AGC Biologics CEO Patricio Massera. "AGC Biologics is committed to continuously expanding our offerings and growing our capacity to serve all the needs of current and future customers. We are very pleased to be adding MolMed and its great cell and gene therapy capabilities and track record to AGC Biologics' global CDMO service offerings."

About AGC Biologics:AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service to clients and partners. The company currently employs more than 1,000 employees worldwide. AGC Biologics' global network spans three continents, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; and Chiba, Japan.

AGC Biologics offers deep industry expertise and unique customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial mammalian and microbial production. Integrated service offerings include plasmid (GMP pDNA) manufacturing, cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression, including the proprietary CHEF1 Expression System for mammalian production. Learn more at http://www.agcbio.com.

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AGC to Complete the Acquisition of MolMed on July 31, 2020 - PRNewswire

Therapeutic Solutions International Files Patent on Ability of QuadraMune Ingredient Pterostilbene to Reduce Inflammation while Stimulating Brain…

OCEANSIDE, Calif., July 28, 2020 /PRNewswire/ --Therapeutics Solution International, Inc., (OTC Markets: TSOI), reported new data demonstrating that the blueberry derived compound pterostilbene possesses numerous brain protective and potentially brain regenerative activities. Pterostilbene is one of four ingredients which comprise QuadraMune, a nutraceutical being developed by the Company which is currently in a clinical trial for prevention of COVID-19. Information on the clinical trial can be found on the Government Clinical Trials website https://clinicaltrials.gov/ct2/show/NCT04421391.

"These new data confirm previous findings published on pterostilbene and also reveal novel therapeutic properties of this naturally occurring nutrient," said Dr. James Veltmeyer, Chief Medical Officer of the Company and Voted Top Doctor of San Diego. "By continually investigating mechanisms of action of our products, our ambition is to ensure we have support of the top medical and scientific leaders. In my opinion, many times, it does not matter how good your product is, what matters is that you have scientific basis for why it works. This is especially important in the current age of molecular medicine."

The data disclosed by the Company indicates:

a) pterostilbene suppresses inflammatory cytokines TNF-alpha, IL-1 beta and IL-6;

b) pterostilbene inhibits death of neurons caused by inflammatory mediators;

c) pterostilbene stimulates production of regenerative factors from cells in the brain such as BDNF, NGF, FGF-1, and FGF-2; and

d) pterostilbene allows/enhances proliferation of endogenous brain stem cells.

"The importance of possessing a deep scientific understanding of your product can be seen in the example of nutraceuticals which ended up obtaining regulatory clearance as drugs," said Timothy Dixon, President and CEO of Therapeutic Solutions International. "For example, Lovaza and Vascepa are both fish oil based products which have been developed scientifically and FDA approved through clinical trials. Lovaza, which is sold by GSK, had sales of approximately 1 billion per year and is used for reduction of triglycerides.1 Vascepa, sold by Amarin, had sales in 2019 of 410 million and is used to prevent heart attacks.2 We believe that similar developmental pathways may be possible with several of our existing products."

The Company is currently pursuing FDA clearance for its cell therapy produce StemVacs, for which an IND number was previously granted. The Company's in-licensed stem cell, the JadiCell has FDA clearance for other indications.

About Therapeutic Solutions International, Inc.Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com, our public forum is https://board.therapeuticsolutionsint.com/.

1 http://www.pmlive.com/pharma_news/teva_launches_first_generic_of_gsks_lovaza_in_us_5592732 https://www.fool.com/investing/2020/01/07/amarin-reports-preliminary-vascepa-sales-projects.aspx

Therapeutic Solutions International, Inc.[emailprotected]

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therapeuticsolutionsint.com

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Therapeutic Solutions International Files Patent on Ability of QuadraMune Ingredient Pterostilbene to Reduce Inflammation while Stimulating Brain...

Novartis receives Piqray approval in Europe the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation | Small…

DetailsCategory: Small MoleculesPublished on Thursday, 30 July 2020 13:55Hits: 588

BASEL, Switzerland I July 29, 2020 I Novartis today announced the European Commission (EC) has approved Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy. Piqray is the first and only treatment specifically approved for people with advanced breast cancer whose tumors harbor a PIK3CA mutation, which stimulates tumor growth and is associated with poor response to therapy13.

Piqray is an important new therapy for HR+/HER2- advanced breast cancer patients whose tumors have a PIK3CA mutation, and we look forward to making it available in countries across Europe, said Kees Roks, Head Region Europe, Novartis Oncology. Knowledge of PIK3CA status can better equip doctors as they develop a personalized upfront treatment plan for patients. Piqray offers new hope for advanced breast cancer patients with a PIK3CA mutation, who typically face a worse overall prognosis.

This approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based on the Phase III SOLAR-1 trial showing that Piqray nearly doubled median progression-free survival (PFS) compared to fulvestrant alone1,2. Overall response rate, an indicator of the proportion of patients who experience at least a 30% reduction in overall tumor size (in patients with measurable disease), was more than doubled when Piqray was added to fulvestrant compared to fulvestrant alone1,2. Read more about the positive CHMP opinion and the SOLAR-1 clinical trial results here.

Patients with HR+/HER2- advanced breast cancer should be selected for treatment with Piqray based on the presence of a PIK3CA mutation in tumor or plasma specimens, using a validated test. If a mutation is not detected in a plasma specimen, tumor tissue should be tested if available.

About Piqray (alpelisib)Piqray is a kinase inhibitor developed for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after endocrine-based regimen. Piqray is approved in 48 countries, including the US and European member states.

Important Safety Information from the PIQRAY EU SmPC The most common ADRs and the most common grade 3 / 4 ADRs (reported at a frequency >20% and 2%, respectively) were plasma glucose increased, creatinine increased, gamma-glutamyltransferase increased, rash, lymphocyte count decreased, nausea, alanine aminotransferase increased, anaemia, fatigue, lipase increased, decreased appetite*, stomatitis, vomiting*, weight decreased, hypocalcaemia, plasma glucose decreased*, activated partial thromboplastin time prolonged*, alopecia**, diarrhoea, hypokalaemia, hypertension, nausea, creatinine increased, and mucosal inflammation (*<2% grade 3/4 ADRs reported, ** no grade 3/4 ADRs reported).

Piqray can cause serious side effects such as severe hypersensitivity, severe cutaneous reactions, hyperglycaemia, pneumonitis, diarrhoea, and osteonecrosis of the jaw.

The following should be taken into consideration prior to or during treatment with Piqray:

Piqray should be permanently discontinued in patients with serious hypersensitivity reactions.

Piqray should not be initiated in patients with a history of severe cutaneous reactions, should be interrupted if signs or symptoms of severe cutaneous reactions are present, and permanently discontinued if a severe cutaneous reaction is confirmed.

Fasting glucose and HbA1c levels should be monitored frequently in the first 4 weeks of treatment, and patients should be advised of the signs and symptoms of hyperglycaemia.

In case of new or worsening respiratory symptoms, the patient should be evaluated for pneumonitis.

Patients should be advised to notify their physician if diarrhoea occurs.

Caution should be exercised when Piqray and bisphosphonates or denosumab are used together or sequentially. Piqray should not be initiated in patients with ongoing osteonecrosis of the jaw.

The efficacy and safety of Piqray has not been studied in patients with symptomatic visceral disease.

Animal studies suggest that Piqray may cause fetal harm in pregnant women. Therefore, as a precaution, women of childbearing potential should use effective contraception while receiving Piqray during treatment and at least 1 week after stopping treatment. Women should not breast feed for at least 1 week after the last dose of Piqray. Piqray may affect fertility in males and females.

Please download full Summary of Product Characteristics for Piqray here.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more athttps://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visithttps://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact This email address is being protected from spambots. You need JavaScript enabled to view it.">This email address is being protected from spambots. You need JavaScript enabled to view it.

References1. Piqray (alpelisib) Prescribing Information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; May 2019.2. Andr F, Ciruelos E, Rubovszky G. Alpelisib for PIK3CA-Mutated, Hormone-Receptor-Positive Advanced Breast Cancer. N Eng J Med 2019.3. Globocan 2018 (WHO), Cancer Today: Estimated number of new cases in 2018, worldwide, females, all ages_1_ 2018.4. Gheorghe D. Breast Cancer. Decision Resources. July 2017:1-338.5. Tolaney S, Toi M, Neven P, et al. Presented at: 2019 American Association for Cancer Research (AACR) Annual Meeting; March 29-April 3, 2019; Atlanta, GA.6. Di Leo A, Johnston S, Seok Lee K, et al. Lancet Oncol. 2018;19(1):87-100.7. Moynahan ME, Chen D, He W, et al. Br J Cancer. 2017;116(6):726-730002E8. The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70.9. Sobhani N, Roviello G, Corona SP et al. The prognostic value of PI3K mutational status in breast cancer: a meta-analysis. J Cell Biochem. 2018;119(6):4287-4292.10. Sabine V, Crozier C, Brookes C, et al. Mutational analysis of PI3K/AKT signaling pathway in tamoxifen exemestane adjuvant multinational pathology study. Journal of Clinical Oncology. 2014;32:2951-2958.11. Miller TW, Rexer BN, Garrett JT, et al. Mutations in the Phosphatidylinositol 3-Kinase Pathway: Role in Tumor Progression and Therapeutic Implications in Breast Cancer. Breast Cancer Res. 2011.12. Saal LH, Johansson P, Holm K. Poor prognosis in carcinoma is associated with a gene expression signature of aberrant PTEN tumor suppressor pathway activity. PNAS. 2007;104(18):7564-7569.13. Thomssen, C., et al. (2020, February 10). International Consensus Conference for Advanced Breast Cancer, Lisbon 2019: ABC5 Consensus Assessment by a German Group of Experts. Retrieved June 16, 2020, from https://www.karger.com/Article/FullText/505957

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Novartis receives Piqray approval in Europe the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation | Small...

The N-terminal domain of the androgen receptor is at the heart of its action – Baylor College of Medicine News

The androgen receptor binds to and mediates the effects of the androgenic hormone testosterone in both males and females. In both genders the androgen receptor regulates hair growth and sex drive. In males, it contributes to the development of sexual characteristics and, importantly, it drives the initiation and growth of prostate cancer, the second-leading cause of death in men.

At Baylor College of Medicine, Dr. Ping Yi, assistant professor of molecular and cellular biology, and her colleagues strive to achieve a better understanding of how the androgen receptor works in cancer by looking in great detail at the 3-D structure of the receptor.

Previous studies had shown that when the androgen receptor binds to testosterone, the resulting molecular complex travels to the cell nucleus where it interacts with DNA, turning genes on or off as necessary to regulate development and growth, Yi said.

To carry on its activity, the androgen receptor also binds to coactivators and other molecules that promote its gene-regulatory function. However, how all these molecules are put together in a functional complex with the androgen receptor was not known.

To treat prostate cancer effectively, we need to better understand how the androgen receptor works, said co-corresponding author Dr. Bert OMalley, chancellor and former long-time chair of the Department of Molecular and Cellular biology at Baylor. In this study, we reveal for the first time the complete 3-D structure of the active, full-length androgen receptor-coactivator complex as it interacts with DNA.

Before this study, researchers only had a partial idea of the 3-D structure of the androgen receptor. They were missing a part called the N-terminal domain, which biochemical evidence suggested might be crucial for its activity. Resolving the complete structure of the receptor would help understand why the N-terminal domain is key to the receptors activity.

Cryo-electron microscopy let us see what the N-terminal domain of the androgen receptor looks like, how the protein is organized and how this and other individual domains contribute to the coactivated protein and its function, said Yi, a member of Baylors Dan L Duncan Comprehensive Cancer Center.

The researchers discovered that the N-terminal domain at the beginning of the androgen receptor is where the coactivators bind, activating the complex that drives prostate cancer. This finding was in marked contrast with what the same researchers had discovered for the estrogen receptor, which is a major driver of breast cancer.

The androgen and the estrogen receptors belong to the same family of steroid nuclear receptors and share similar 3-D structures. However, despite having general structural similarities, in the estrogen receptor the coactivators bind not to the N-terminal domain at the beginning of the molecule, but to the C-terminal domain at the end of the molecule. This finding has important implications generating drugs for cancer treatment.

The androgen receptor drug inhibitors that are currently available for prostate cancer treatment bind to the C-terminal domain, which we found is not the main interactive site of the androgen receptor, OMalley said. Our work strongly supports further studies to determine the effect that drugs directed at the androgen receptors N-terminal domain have on prostate cancer growth.

Our study provides a starting point to understand what is happening to the androgen receptor molecular machine in prostate cancer, said co-corresponding author Dr. Zhao Wang, assistant professor in the Verna and Marrs McLean Department of Biochemistry and Molecular Biology. Our findings also generate a broader therapeutic space for the treatment of not only prostate cancer but also related diseases, as well as new information on basic mechanisms of regulation of gene expression.

Interested in learning all the details of this study? Find it in the journal Molecular Cell.

Other contributors to this work include co-first author Xinzhe Yu, Ross A. Hamilton, Hong Shen, Muyuan Chen, Charles E. Foulds, Michael A. Mancini and Steven J. Ludtke, all from Baylor College of Medicine.

This work is supported by NIH-NICHD and grants (HD8818, HD07857 and NIDDK59820, GM080139 and GM121203); DOD W81XWH-15-1-0536; CPRIT grant (RP150648); the Robert Welch Foundation (Q-1967-20180324 and BCM BMB department seed funds). Further support was provided by NCI Cancer Center Support Grant P30CA125123 (BCM Monoclonal Antibody/Integrated Microscopy Core/Recombinant Protein Expression Core Facility) and the Cryo-EM supported by Advanced Technology CPRIT Cryo-EM/ET Core (1RP190602) at BCM.

By Ana Mara Rodrguez, Ph.D.

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The N-terminal domain of the androgen receptor is at the heart of its action - Baylor College of Medicine News

Headaches, memory loss and extreme fatigue among long-lasting symptoms of COVID-19 – The Owensboro Times

Graphic by Owensboro Times

Four months into the coronavirus outbreak in the U.S., people that tested positive for COVID-19 are still experiencing life-changing effects.

Bathing, cooking or washing clothes have become challenging tasks for some survivors, and patients seemingly recovered from the virus have returned to the hospital weeks later with a stroke or heart attack.

Theyre noticing that walking upstairs is hard when they used to be a runner, said Dr. Rebecca Dutch, virologist and chair of the University of Kentuckys Department of Molecular and Cellular Biochemistry, who is helping coordinate the universitys COVID-19 research.

These long-term symptoms are happening widely across the globe and are affecting both younger and older adults. Last week, the Centers for Disease Control and Prevention suggested, based on a new survey, that COVID-19 can result in prolonged illness in young adults without underlying chronic medical conditions.

About one-third of adults with positive outpatient test results and about one in five adults aged 18-34 with no chronic medical conditions had not returned to their usual state of health two or three weeks after testing.

Data from the COVID Symptom Study app, created by researchers at Kings College London, revealed that about 10 percent of the nearly four million people contributing to the app had effects lasting more than four weeks.

Its becoming clearer that there are long-term residual effects, said Dr. Todd Rice, a critical care medicine specialist and pulmonologist at Vanderbilt University Medical Center who has been treating COVID-19 patients since early March.

Muscle aches, difficulty breathing, headaches, difficulty concentrating, memory loss and coughs have been widely reported lingering symptoms. There have also been accounts of heart palpitations, night sweats, hair loss and rashes.

Chronic fatigue is possibly the most common debilitating impact, and it seems to be more prolonged than what has been previously seen from viral infections.

This just seems to go on much longer, said Rice, who has patients that contracted the virus in March that are still not recovered. It just wears people out. They just dont have energy.

There have also been reports of young children developing a post-inflammatory syndrome, called multisystem inflammatory syndrome, after contracting the virus. It affects multiple organs, such as the kidney, liver, heart, lungs and brain, and can cause symptoms like breathing problems, confusion and delirium, according to Rice, who added that it was rare in adults.

Anybody can get it. Anybody can get really, really ill, and anybody can get these long-term effects from it, Rice said. If youre young, and have 50 years left in your life, youre going to want to avoid this so you dont have 50 years of lingering effects.

COVID-19 impacts many parts of the body. For most individuals, the effects might appear as a fever, cough or loss of smell. But there could also be abdominal pain, diarrhea, or swelling in the fingers or toes.

When you get millions of people infected, even if something is quite a rare event, you will start to see it, Dutch said.

But further investigation is needed to understand the long-term symptoms, how prevalent they are and whats causing them. Research is also needed to help determine how to prevent the symptoms or lessen and shorten the duration of effects.

The hard part is that its likely that the treatments will need to be done before the lingering symptoms start, Rice said, as opposed to addressing the symptoms after they appear.

Research indicates that the long-lasting symptoms could be from damage to the body during the illness or an immunological response after the initial disease.

Its possible that some symptoms could result from a lingering viral infection. Most patients test negative several weeks after contracting the virus, but there have been rare cases of people testing positive for several months.

With limited data and observations, many questions remain unanswered.

Were just now starting to understand these longer-term effects, Rice said. What are the real long-term effects, a year or two down the road? We dont know yet.

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Headaches, memory loss and extreme fatigue among long-lasting symptoms of COVID-19 - The Owensboro Times

Neanderthal Gene Linked to Increased Pain Perception | Present – Explica

Neanderthal life was not easy. Ice age hunter-gatherers barely survived throughout western Eurasia, hunting mammoths, bison, and other dangerous animals.

Now, a pioneering study of its genome, published in Current Biology, reveals that, despite their harsh existence, Neanderthals had a biological predisposition to perceive pain more intensely. Evolutionary geneticists discovered that these ancient human relatives carried three mutations in a gene that codes for the NaV1.7 protein, which transmits painful sensations to the spinal cord and brain. They also showed that, in a sample of British citizens, those who had inherited the Neanderthal version of NaV1.7 often feel more pain than others.

For me, it is a first example of how we started to get a possible idea about Neanderthal physiology taking current people as transgenic models as a reference, says Svante Pbo, from the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, who led the study. with Hugo Zeber of the Karolinska Institute in Stockholm.

A protein related to pain perception

The researchers have had access to only a few Neanderthal genomes, and most of them have been sequenced at low resolution. This has made it difficult to identify mutations that occurred after their lineage separated from that of todays humans, between 500,000 and 700,000 years ago. But in recent years, Pbo and his team have obtained three high-quality Neanderthal genomes from DNA found in caves in Croatia and Russia. This has allowed them to identify mutations that were surely very common in Neanderthals, but are very rare in humans today.

Mutations in a gene called SCN9A which codes for the NaV1.7 protein persisted because all Neanderthals had three mutations that altered the shape of the protein. The finding of the mutated form of the gene in both sets of chromosomes in the three Neanderthals indicates that it was common in all their populations.

NaV1.7 acts on the nerves in the body, controlling the extent to which pain signals are transmitted along the spinal cord to the brain. They have described it as a kind of volume control, which determines the amount of pain transmitted by nerve fibers, says Zeberg. Some people who have extremely unusual gene mutations that turn off the protein do not feel pain, while other changes may predispose people in question to suffer from chronic pain.

To investigate how mutations may have altered Neanderthal nerves, Zeberg introduced his version of NaV1.7 in frog eggs and human kidney cells useful model systems for characterizing the proteins that control nerve impulses. The protein was more active in cells that had all three mutations than in cells that had not undergone those changes. In nerve fibers, this could lower the threshold from which a painful signal would be transmitted, says Zeberg.

He and Pbo then searched for humans with the Neanderthal version of NaV1.7. About 0.4 percent of participants in the Britains biobank, a database of the genomes of half a million Britons, who claimed to have painful symptoms, had a copy of the mutated gene. No one had two, as was the case with Neanderthals. Participants with the mutated version of the gene were 7 percent more likely to experience pain in their daily lives than people without it.

Sensitive Neanderthals

It is a beautiful job, because it shows how some aspects of Neanderthal physiology can be reconstructed by studying modern humans, says Cedric Boeckx, a neuroscientist who works at the Catalan Institution for Research and Advanced Studies in Barcelona, Spain. In a 2019 study, Boeckx noted three other proteins involved in pain perception that are different in modern humans and Neanderthals. Those changes may be evidence of differences in resilience between the two species, Boeckx says.

Pbo and Zeberg caution that their findings do not necessarily mean that Neanderthals would have felt more pain than modern humans. The sensations transmitted by NaV1.7 are processed and modified in the spinal cord and in the brain, which also contributes to the subjective experience of pain.

Gary Lewin, a neuroscientist at the Max Delbrck Center for Molecular Medicine in Berlin, points out that Neanderthal variants have little influence on the function of NaV1.7 let alone other mutations that are associated with chronic pain. It is hard to imagine why a Neanderthal would want to be more sensitive to pain, he adds.

It is not clear if the mutations evolved because they were beneficial. Neanderthal populations were made up of few individuals and their genetic diversity was low conditions that can help harmful mutations persist. But Pbo believes that change smells like a product of natural selection. So he plans to sequence the genomes of about a hundred Neanderthals, which could help provide some answers.

In any case, pain is adaptive, says Zeberg. It is not particularly bad to feel pain.

Ewen Callaway

Reference: A neanderthal sodium channel increases pain sensitivity in present-day humans, by H. Zeberg et al., In Current Biology, published on July 23, 2020.

Article translated and adapted by Research and Science with permission from Nature Research Group.

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Neanderthal Gene Linked to Increased Pain Perception | Present - Explica

Imaging accreditation org RadSite announces new CMO, and other recent radiology job changes – Health Imaging

Radiology Partners president steps down

Jay Bronner, Rad Partners first-ever CMO announced Wednesday that he will be stepping down as president of the El Segundo, California, imaging provider.

When I joined RP, my colleagues and I aspired to build the leading radiology practice in the country, he said in a statement. Now, reflecting on everything thats been accomplished, Id say weve achieved that goal in many ways.

As of this month, Bronner moved into a part-time position, and said he is not seeking a new position elsewhere. The imaging giant also said it will be evaluating the vacated role over the next few months.

Radiology Business has more on the recent decision.

ACR names new director of policy institue

The American College of Radiology named Elizabeth Y. Rula, PhD, the new executive director of the Harvey L. Neiman Health Policy Institute. She will oversee Neiman HPIs efforts to advance evidence-based imaging policy, the ACR announced earlier this month.

Rula has more than a decade of healthcare leadership experience, most recently as executive director of research and thought leadership at Tivity Health. She succeeds Danny Hughes, PhD, who led the institute since its beginnings in August 2012. Read more here.

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Imaging accreditation org RadSite announces new CMO, and other recent radiology job changes - Health Imaging

Coronavirus Many specialists now advocate the usage of masks: The protecting impact is giant and statistically important – Pledge Times

Finland there is a heated debate about face masks. With most of the Nordic countries, Finland is one of the few places in the world where no general face mask recommendation or compulsion has been issued.

Of the Nordic countries, Iceland said on Thursday that it would tighten measures against the spread of the coronavirus. For the first time in Iceland, a mask obligation will be introduced on public transport, domestic flights, ferries and hairdressing salons.

The new restrictions will take effect on Friday and will last for at least two weeks.

Most countries in the world has introduced a mask compulsion or at least a recommendation to use a mask in public places to combat a coronavirus pandemic.

In June, the World Health Organization (WHO) changed its recommendation on the use of the mask. The WHO now recommends the mask for use in public transport, workplaces and grocery stores, for example.

Finland no general mask recommendation or compulsion has been issued throughout the period of the coronavirus epidemic. In healthcare, masks are used, and by individual actors such as the airline Finnair and University of Tampere, have prescribed mask packs.

The Government has not issued a general recommendation on the use of a face mask. In the fight against the coronavirus epidemic, the Finnish government recommends, among other things, keeping safety gaps, coughing up a sleeve or handkerchief, washing hands diligently and paying attention to people at risk.

The position of the National Institute for Health and Welfare (THL) has not changed during the epidemic. THLs website still reads, there is no evidence that extensive use of the mask in healthy individuals would help reduce infections.

Also, according to the WHO, scientific research still does not clearly show how much the widespread use of masks by ordinary people would be. However, the recommendation was amended because experience has been gained in different countries with the benefit of the mask, especially when it is not possible to maintain safety distances.

Finland mask recommendation or coercion has been put down especially for such situations. Assistant Chief Physician, Department of Infectious Diseases, Helsinki and Uusimaa Hospital District (Hus) Eeva Ruotsalainen recalls that safety gaps do not work, for example, on public transport.

Thats when the face mask provides protection to prevent the spread of the epidemic, as the disease mainly spreads by inhalation. Therefore, a face mask is able to combat the epidemic. I recommend it in congestion areas and I also hope for a national recommendation, especially if the incidence of the disease starts to increase, says Ruotsalainen.

Huss director of diagnostics Lasse Lehtonen is on the same lines as the Swede.

I think the recommendations of the WHO and the European Office of Communicable Diseases are good and up-to-date. They recommend using masks in situations where distances cannot be maintained. It is justified to use them in public transport, for example. In Finland, it would be good to practice it on trains, buses and metros.

However, Lehtonen is not any proponent of mask coercion.

They should be available and a social pressure should be created where they would just start to be used. With people now returning to work, its pretty hard to keep their distance on the subway and buses. In that sense, the mask recommendation would be quite justified, says Lehtonen.

On Friday Hanna Ollila and Liisa Laine wrote in HSs Guest Pen writing that their study found that face shields reduce the risk of a respiratory infection by a third.

The protective effect is large and statistically significant. Masks are most useful when combined with safety gaps and hand washing. Ollila and Laine write.

We propose that a mask recommendation be introduced in Finland, especially in areas of active epidemics and in public transport, together with good hand hygiene, avoidance of close contact and testing and tracing.

Ollila is a team leader at the Finnish Institute of Molecular Medicine at the University of Helsinki and a researcher at Stanford University in the United States. Laine is a postdoctoral researcher at the Leonard Davis Institute of the University of Pennsylvania, USA.

Virus Infectious Status has remained stable in Finland. During the last follow-up week (20-26 July), 51 cases were reported to the Communicable Diseases Register, THL. During the week, an average of four thousand coronavirus tests were performed per day.

Number of tests has risen since June.

Assistant Professor of Threatening Infectious Diseases at the University of Helsinki Tarja Sironen stated In an interview with HS last weekthat although the situation is good in Finland, it is still bad in the world.

Once the borders are open, it is clear that there will be more cases. Maybe it would be good to learn how to use a mask, get them at home and watch how the situation changes, Sironen estimates.

According to Husin Lehtonen, the mask recommendation is also about educating the attitude of the population:

Finland does not have the same attitude to the use of masks as, for example, in Asian countries. Its a new thing for us, but we also learned to use our hands quickly and we would certainly learn masks if we just started practicing, says Lehtonen.

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Coronavirus Many specialists now advocate the usage of masks: The protecting impact is giant and statistically important - Pledge Times

Scipher Medicine Announces Publication of Clinical Study Validating PrismRA, a Blood Test Predicting Non-Response to TNF Inhibitor Therapies in…

PrismRA identifies patients 6.6 times less likely to respond to TNFi therapy

Scipher Medicine, a precision immunology company that helps match patients with their most effective therapy, today announced successful results from the PrismRA clinical validation study. The publication titled "Clinical validation of a blood-based predictive test for stratification of response to tumor necrosis factor inhibitor therapies in rheumatoid arthritis patients" was published in Network and Systems Medicine.

The study, co-authored by scientists from Scipher Medicine and experts in the field of clinical rheumatology, met the endpoint of determining a molecular signature that accurately predicts rheumatoid arthritis (RA) patients who will fail to respond adequately to tumor necrosis factor inhibitor (TNFi) therapies. Empowered with this information, healthcare providers can prescribe alternative therapy from day one without first having to cycle through and fail multiple TNFi drugs.

PrismRA uses whole blood gene expression data to identify if a patients molecular disease biology is suited to TNFi therapy. PrismRA is expected to be introduced to rheumatology practices later this summer and has the potential to improve treatment decisions and reduce trial-and-error attempts with treatments that are unlikely to be effective based on a patients unique biology.

"About 90% of patients with rheumatoid arthritis are prescribed TNFi therapy after failing disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate. However, a majority of patients fail to achieve a clinically meaningful change," said Dr. Slava Akmaev, Chief Technology Officer of Scipher Medicine. "The need for precision medicine in RA and other complex diseases has never been more obvious, particularly now with provider access being severely limited due to heightened COVID-19 pandemic concerns. PrismRA has the ability to limit TNFi drug cycling and help patients manage their disease more effectively."

"In this study, TNFi therapies failed to help nearly 70% of the unstratified patient population reach an adequate response. The PrismRA disease signature test could have prevented many of these individuals from taking a drug that did not adequately ameliorate the signs and symptoms of their disease," said Jeffrey Curtis, M.D., M.S., MPH, Professor of Medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham. "RA is a complex disease with multiple biological factors implicated in disease progression and severity. A test such as PrismRA has the potential to be a powerful tool for treating patients with the right treatment at the right time."

PrismRA was validated using the Comparative Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) data set of 175 biologic-nave RA patients from the Consortium of Rheumatology Researchers of North America (CORRONA). PrismRA identified patients who were unlikely to have an adequate response to TNFi therapies with a positive predictive value (PPV) of 89.7% and specificity of 86.8%. Overall, a patient identified by PrismRA to be a non-responder is 6.6 times more likely to inadequately respond to a TNFi therapy compared to someone lacking that molecular signature.

About PrismRA

PrismRA, a molecular signature test, is a revolutionary advancement bringing precision medicine to the treatment of rheumatoid arthritis, which affects 1.3 million patients in the United States alone. From a routine blood draw, PrismRA analyzes an individual's molecular signature, helping identify who is unlikely to adequately respond to TNFi therapy, the worlds largest selling drug class. Providers now have objective data to guide therapeutic decision-making and give patients the best chance of achieving treatment targets and improving clinical outcomes. For more information, please visit http://www.PrismRA.com.

About Scipher Medicine

Scipher Medicine, a precision immunology company, holds the fundamental belief that patients deserve simple answers to treatment options based on scientifically backed data. Leveraging our proprietary Network Medicine platform and artificial intelligence, we commercialize blood tests revealing a patients unique molecular disease signature and match such signature to most effective therapy, ensuring optimal treatment from day one. The unprecedented amount of patient molecular data generated from our tests further drives development of novel and more effective therapeutics. We partner with payers, providers and pharma along the health care value chain to bring precision medicine to autoimmune diseases.

Scipher Medicine is backed by Khosla Ventures, Northpond Ventures and UnitedHealth Group. Visit http://www.sciphermedicine.com and follow Scipher on Twitter, Facebook and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200728005364/en/

Contacts

Media Contact: Cassidy McClainCassidy@canalecomm.com 619.849.6009

Company contact:Andrea Mooreandrea.moore@sciphermedicine.com 801-209-1175

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Scipher Medicine Announces Publication of Clinical Study Validating PrismRA, a Blood Test Predicting Non-Response to TNF Inhibitor Therapies in...

Biomedical journal edited at School of Medicine and Perinatology Research Branch receives top ranking – The South End

The American Journal of Obstetrics & Gynecology, edited at the Wayne State University School of Medicine and the Perinatology Research Branch, has received the highest Impact Factor of all journals within the discipline reporting original research.

Last month, Journal Citation Reports announced that the Impact Factor of AJOG is now 6.502, placing it first among journals publishing original research in obstetrics and gynecology.

The Impact Factor, the yearly average number of citations that articles published in the last two years in a given journal received, is provided annually by Journal Citation Reports. The measure is considered an index of prestige of a journal.

AJOG ranked top in Eigenfactor score, a sophisticated measure of journal impact, calculated by taking into account the impact factor of the citing journal and adjusting for self-citations. AJOG also had the highest number of citations among all journals in the discipline for 2019, with a total of 41,245.

AJOGs editor-in-chief for Obstetrics is Roberto Romero, M.D., D.Med.Sci., chief of the Perinatology Research Branch of the National Institute of Child Health and Human Development/National Institutes of Health, and professor of Molecular Obstetrics and Genetics at the Wayne State University School of Medicine. The editor-in-chief for Gynecology is Catherine Bradley, M.D., MSCE, professor of Obstetrics and Gynecology, Epidemiology, and Urology at the University of Iowa.

"With a distinguished past, AJOG is deeply committed to innovation and publishing the best groundbreaking research that improves the health care of women, Dr. Romero said.

Known as the Gray Journal, the American Journal of Obstetrics & Gynecology has been the premier academic journal in the discipline for more than 150 years. More than 41,000 obstetricians and gynecologists worldwide receive the print version.

Among the groundbreaking discoveries that have changed the practice of medicine and the lives of women and their families that have been published on its pages include:

The Pap smear for the detection of cervical cancer; The assay for the detection of early pregnancy (pregnancy test), used worldwide; Polycystic ovarian disease, which affects 5% to 10% percent of women of reproductive age; The first graphic display of the labor curve, which has led to partograms in every labor and delivery unit; and The importance of progesterone in pregnancy maintenance.

This year, AJOG has published:

A randomized clinical trial of cervical cerclage in twin gestations with a dilated cervix; Vaginal progesterone for the prevention of preterm birth in twin gestations; The use of a rapid point-of-care test to assess intra-amniotic inflammation in patients with ruptured membranes; and The outcome of COVID-19 in pregnant women.

The PRB of NICHD/NIH is housed at Wayne State University and the Detroit Medical Center, strategically located to serve a high-risk pregnant population. The Perinatology Research Branch has produced groundbreaking clinical and translational research, and cared for more than 25,000 mothers in Detroit.

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Biomedical journal edited at School of Medicine and Perinatology Research Branch receives top ranking - The South End

Myriad Launches Proprietary AMPLIFY Technology, Further Increasing the Performance of its Prequel NIPS Test – GlobeNewswire

SALT LAKE CITY, July 29, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today that the company has launched its proprietary AMPLIFY technology, which further increases the performance of its Prequelnoninvasive prenatal screening (NIPS) test. The proprietary AMPLIFY process increases the fetal fraction of a NIPS sample by preferentially sequencing the fetal cell-free DNA fragments that circulate in a mothers blood. AMPLIFY technology enables more accurate detection of fetal chromosome abnormalities. In the analytical validation involving samples from more than 1,000 pregnant women, fetal fraction is 2.3 times greater on average with AMPLIFY than with standard NIPS. This improvement reduces false positive and false negative resultsincluding for common aneuploidies, expanded aneuploidies, microdeletions and a babys sex. For instance, false negative performance in common aneuploidies improves 45x with AMPLIFY technology. Additionally, no samples powered by AMPLIFY technology had a fetal fraction below four percent. Other laboratories may fail samples with less than four percent fetal fraction.

Prequel already provided highly accurate results and this proprietary technology further increases the sensitivity of our test, said Nicole Lambert, president of Myriad International, Oncology and Womens Health. With AMPLIFY, Prequel maintains an industry-leading low rate of failed samplesdelivering results to 99.9 percent of patients. The important clinical benefits are that each woman who receives the test can expect highly accurate NIPS results, regardless of body mass index (BMI), race, or ethnicity.

Up to 50 percent of pregnant women present with high BMI to their healthcare provider. Studies have demonstrated that BMI is not evenly distributed across ethnicities, and up to 24 percent of women with high BMI will not receive a result on standard NIPS platforms due to low fetal fraction. Women who dont receive a result may do no further prenatal screening at all; they may go through subsequent rounds of NIPS, or they may undergo invasive procedures such as an amniocentesis or chorionic villus sampling, which can increase the risk of miscarriage and add unnecessary expense to the US healthcare system. Prequel with AMPLIFY technology overcomes the limitations of standard NIPS in order to provide equity of care to pregnant women.

About Prequel Prenatal ScreenThe Myriad Prequel Prenatal Screen is a non-invasive prenatal screen (NIPS) that uses cell-free DNA (cfDNA) to determine if a pregnancy is at an increased risk for chromosome abnormalities, such as Down syndrome. Compared to screening methods which use maternal age, ultrasound and serum screening, Prequel has been shown to be superior than by achieving a lower false-positive rate and false-negative rate than these other methods. Among other NIPS, Prequel has an industry leading test failure rate of 0.1 percent. The Prequel Prenatal Screen can be ordered with the Foresight Carrier Screen and offered to all women, including those with high body mass index, and ovum donor or a twin pregnancy.

About Myriad GeneticsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to launch of the Companys proprietary AMPLIFY technology; and the Companys strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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Myriad Launches Proprietary AMPLIFY Technology, Further Increasing the Performance of its Prequel NIPS Test - GlobeNewswire

Myriad Announces the Launch of a New Radiographic Progression Prognostic Tool, Adding to Clinical Value of Vectra – BioSpace

SALT LAKE CITY, July 28, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today that the company has launched a new enhancement that is now available on its Vectra test report. The new test report provides an individualized estimate of a patients one-year risk of rapid radiographic progression (RP). The RP result in every report is personalized based on the patients age, gender and adiposity.

We previously presented data demonstrating that Vectra is the best single predictor of joint damage. Inclusion of information on RP risk in the Vectra test report now gives clear insight into both the patients current rheumatoid arthritis (RA) inflammation and the future risk of joint damage, said Mark S. Verratti, president of Myriad Neuroscience and Myriad Autoimmune. With this new product enhancement, Vectra as a prognostic tool can help further guide medical management decisions for patients with RA.In a combined analysis of patients from three studies, 42 percent of patients thought to be in low or moderate disease activity assessed by a traditional disease activity measure were in high disease activity as measured by Vectra, and thus were at risk of irreversible joint damage within one year. Each patient will receive an individualized percentage risk prediction for radiographic progression within one year (see Example 1 below), helping physicians and patients make treatment decisions.

To view Example 1: The Vectra Score correlates to the risk of radiographic progression, please visit the following link: https://www.globenewswire.com/NewsRoom/AttachmentNg/1ed33a2f-4c29-4cbb-8b86-c12f819b9910

RA is an inflammatory autoimmune disease that attacks a patients joints and often affects other organ systems. RA is a contributing condition that leads to increased disability, significant morbidity, increased mortality and financial burden. Lost productivity associated with RA is substantial, with approximately 20-70 percent of individuals working at the time of their RA diagnosis were disabled after seven to 10 years. RA affects roughly more than one million people in the United States. The Vectra Score measures the concentrations of 12 serum biomarkers and an algorithm is applied to these biomarker concentrations to calculate a disease activity score on a scale of 1 to 100. Vectra Disease Activity Levels are as follows: Green = Low: 1 to 29, Orange = Moderate: 30 to 44, Red = High: 45 to 100. The risk of RP is shown as a function of Vectra Score. The definition of RP is a 1-year total Sharp score change of >5 units. Increased risk of RP means a greater chance of irreversible joint damage.

Three out of four rheumatologists have used Vectra and have ordered more than one million tests for their RA patients. The American College of Rheumatology (ACR) includes Multi-Biomarker Disease Activity Score (Vectra) as a disease activity measure that meets minimum standards for regular use for patients with rheumatoid arthritis. Those recommendations were published in the journal Arthritis Care & Research.

About VectraVectra is a multi-biomarker molecular blood test that provides an objective and personalized measure of inflammatory disease activity in patients with rheumatoid arthritis. Vectra demonstrates unsurpassed ability to predict radiographic progression and can help guide medical management decisions to improve patient outcomes. Vectra testing is performed at a state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician five to seven days from shipping of the specimen. Physicians can receive test results by fax or the private provider web portal, VectraView. For more information on Vectra, please visit: http://www.VectraScore.com.

About Myriad GeneticsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to launch of Radiographic Progression estimates on Vectra test reports; and the Companys strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Example 1: The Vectra Score correlates to the risk of radiographic progression

Example 1: The Vectra Score correlates to the risk of radiographic progression

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Myriad Announces the Launch of a New Radiographic Progression Prognostic Tool, Adding to Clinical Value of Vectra - BioSpace

Dr. Victor J. Thannickal named to lead Deming Department of Medicine – News from Tulane

Victor J. Thannickal, MD, will join School of Medicines John W. Deming Department of Medicine in January 2021.

Victor J. Thannickal, MD, has been named The Harry B. Greenberg Chair in Tulane University School of Medicines John W. Deming Department of Medicine. He joins the university in January 2021.

Thannickal is a professor of medicine and pathology at the University of Alabama at Birmingham (UAB); the Ben Vaughan Branscomb Chair of Medicine in Respiratory Disease; director of the Division of Pulmonary, Allergy, and Critical Care; and vice chair for research, Department of Medicine.

The Department of Medicine is one of the largest clinical departments within the Tulane School of Medicine, with an expansive research program that extends from the basic sciences of physiology and disease to the application of knowledge in clinical and community settings.

Thannickals research focuses on cellular and molecular mechanisms of lung repair and regeneration. Discoveries from this work have led to the identification of a number of drug targets for the treatment of fibrotic lung disease. He has multiple active grants from the National Institutes of Health, including a translational Program Project grant from the National Heart, Lung and Blood Institute.

I am pleased to join an outstanding group of clinicians, educators and scientists within the Deming Department of Medicine at Tulane University, Thannickal said. Tulane has a legendary history of major contributions to science and medicine. I look forward to building on this legacy by establishing leading research and training programs at both the graduate and post-graduate levels. We aspire to make scientific discoveries that address global pandemics and health inequalities, while contributing to the creation of healthier populations worldwide.

A graduate of Oral Roberts University School of Medicine in Tulsa, Oklahoma, Thannickal served a fellowship at Tufts University School of Medicine. Later, he held faculty positions at Tufts, University of Michigan and UAB, where he currently directs the Division of Pulmonary, Allergy, and Critical Care Medicine. Under his leadership, the division has grown to over 75 faculty members and expanded its research and educational programs, including the institution of a highly successful NIH T32 Training Program in Lung Biology and Translational Medicine. Research funding for the division has grown to over $25 million per year under his tenure, making it one of the top-funded divisions in the country. Thannickal has a passion for mentoring and team-building; trainees from his laboratory have moved on to independent careers at multiple academic medical centers across the United States.

We are fortunate to have attracted a leader and innovator of Dr. Thannickals caliber to head the Deming Department of Medicine, said Lee Hamm, MD, senior vice president and dean of the School of Medicine. His collaborative and forward-thinking vision will have an impact not only on our largest department, but across the entirety of Tulane University and the global community we serve.

Thannickal is an elected member of the Association of American Physicians and the American Clinical and Climatological Association. He is the recipient of the American Thoracic Society Recognition Award for Scientific Accomplishments. He currently serves on the editorial boards of the Journal of Clinical Investigation (Consulting Editor), as well those of the American Journal of Respiratory and Critical Care Medicine and the American Journal of Pathology; and is an associate editor of the American Journal of Respiratory Cell and Molecular Biology.

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Dr. Victor J. Thannickal named to lead Deming Department of Medicine - News from Tulane