Monthly Archives: May 2021

In early cancer thats amenable to surgery, a field viewed as the next battleground for PD-1/L1 immunotherapies, Roches Tecentriq has claimed the first post-operative win innon-small cell lung cancer. But the drugs role, at least in some patients, remains unclear.

Tecentriq slashed the risk of cancer recurrence or death after surgery by 34% in a studyslated for the virtual American Society of Clinical Oncology meeting next monthbut onlyin patients with stage II to IIIA disease whose tumors bore the PD-L1 biomarker.

Charles Fuchs, M.D., head of oncology andhematology product development at Roches Genentech, called the win a transformative step in helping patients with early-stage lung cancer.

Historically, improving a disease-free survival by 20% or 30% has been practice-changing and really meaningful when youre talking in a curative setting, Fuchs said in an interview.

But when all patients in the IMpower010 studyare counted, the number drops to 19%raising questions about how broad an FDA approval might be and whether doctors would actually use the drug for post-surgeryNSCLC.

Plus, the 34% recurrence reduction rate Tecentriq achieved in the carved-out subgroup was way lower than the 83% AstraZenecas small-molecule drug Tagrisso accomplished in patients with EGFR-mutated stage II to IIIA disease in its own phase 3 Adaura trial.

While Tagrisso targets a niche population, physicians are benchmarking their interest in Tecentriqs post-surgery adjuvant use against the EGFR inhibitor data right now, becausedata hasntyet shownwhether either drug can help patients live longer.

RELATED:Roche's Tecentriq is the first I-O drug to claim a post-surgery win in lung cancer. But will doctors use it?

Fuchs acknowledged the field is evolving but stressed that Tagrissos impressive showing was in a small subset of patients, whereas PD-L1-positive disease makes up 40% to 50% of all NSCLC cases. So he called Tecentriqs 34% improvement as clinically meaningful and practice-changing.

The next question centers onTecentriqs benefit for PD-L1-negative patients. When those trial subjects were counted, Tecentriqs reduction of disease recurrence dropped to 21%, which is still statistically significant. Butthe rate fell below the statistical significance bar to 19% once all randomized patients, including those with stage IB disease, were included.

Fuchs suggests that data from the stage IB patientswho made up 12% of the total trial populationare immature at the interim analysis because those patients are healthier;it takes longer for that group to accrue recurrence cases.

RELATED:AstraZeneca's blockbuster Tagrisso gets major boost with FDA OK for early lung cancer use

During Roches first-quarter earnings call a few weeks ago, Roches pharma chief Bill Anderson put the size of the market for resectable lung cancer at between $2 billion and $3 billion. But he also acknowledged the uncertainty of whether Tecentriq is for only PD-L1-positive patients or for all patients. He said he expectsmore mature disease-free survival data to answer that question.

Roche isnow talking to the FDA and the European Medicines Agency to see what we collectively think is in the best interest of patients in terms of a potential label for Tecentriqs NSCLC adjuvant use, Fuchs said.

As Roche awaits key life extension data from the IMpower010 trial, a recent survey by Jefferies analyst Peter Welford suggested that almost all physicians would rather wait until that data emerge to consider using a PD-1/L1 therapy in that group.

One reason for caution is the uncertainty of whether PD-1/L1 inhibitors will work in metastatic cancer patients who were treatedwith one of the drugs early on. Its possible that physicians might reserve PD-1/L1 for more advanced disease; Mercks PD-1 inhibitor Keytruda combined with chemo has become the standard of care for front-line treatment of metastatic disease because its proven to help patients live longer.

The question of sequential PD-1/L1 use needs to be addressed, Fuchs said, but he stressed the importance of advancing the landscape of cancer immunotherapy beyond the PD-1/L1s.

Meanwhile, other PD-1/L1 players are also targeting adjuvant NSCLC. These include Ketyrudas Keynote-091 trial, which is expected to deliver data later this year.

Read the rest here:

ASCO: Roche's Tecentriq grabs I-O's first win in post-surgery lung cancer, but it's limitedand an FDA approval could be, too - FiercePharma

PERTH (miningweekly.com) Federal Resources Minister Keith Pitt has thrown his support behind the development of further liquefied natural gas (LNG) projects, in Western Australia, saying they would be needed to support increased global demand.

Global gas demand is forecast to grow by 1.5% on average per year out to 2025, providing incentive to ensure our large gasfields like Scarborough and Browse are developed as soon as possible.

Australias large upcoming offshore gas developments such as the Scarborough, Browse and the Barossa projects, will create thousands of new high-wage jobs, including nearly 5 000 jobs during construction and more than 1 000 operational jobs, Pitt said this week.

The Scarborough gasfield, being developed by ASX-listed Woodside, is estimated to contain a contingent resource of some 11.1-trillion cubic feet.

Fellow-listed Santos took a final investment decision on its $3.6-billion Barossa gas and condensate project in March this year, also kick-starting a $600-million investment in the Darwin LNG life extension and pipeline tie-in projects, which will extend the facility life for around 20 years. The Santos-operated Darwin LNG plant has the capacity to produce approximately 3.7-million tonnes of LNG per annum.

Australia is ready to capitalise on the expected growth in global gas demand driven by Asian economies. The use of carbon capture and storage (CCS) is a critical enabler of emerging energy technologies, Pitt said this week.

I am pleased to note that Tuesdays Budget committed A$263.7-million over 10 years to fund the carbon capture utilisation and storage (CCUS) Hubs and Technology Program, building on the A$50-million previously announced in the CCUS Development Fund.

Pitt said the Yara Pilbara plant was a great example of using gas to add value to valuable commodities for farmers and the resources industry.

The Yara plant uses natural gas in the production of fertiliser ammonia, and the further processing into ammonium nitrate for use in the mining industry.

The Yara Pilbara facilities are a great example of downstream uses of natural gas, with the company exporting fertiliser to help grow crops and feed the world from the nearby Port of Dampier, Pitt said.

More here:

Mining Weekly Pitt punts more gas - Creamer Media's Mining Weekly

Edible peel startup Apeel, which works to eliminate food waste and plastic pollution, has acquired AI hyperspectral imaging tech company ImpactVision, and by integrating this new tech into their application systems at supplier locations around the world, they will be able to help food suppliers and retailers in extending the shelf life of their fresh produce on a larger scale.

California-based food tech firm Apeel acquired ImpactVision for an undisclosed amount to use the latters imaging technology enabling suppliers to literally look inside their produce and understand the interior quality of the items.

Before this, Apeel had developed an edible peel technology which helps extend the shelf-life of fresh produce and was recently used by retail giantWalmart to trial plastic-free cucumbers given that the former uses leftover food materials like peel or skin of avocados, limes, apples, etc. and produces a blend that creates a protective layer for the produce. This results in the produce lasting 2x longer than it normally would as the peel slows down the water loss and oxidation that could make the produce go bad.

Now with this new technology, the company will be able to assess the quality of products by collecting quantifiable data on ripeness, freshness, nutritional density, and other indicators of the quality of the produce. To understand this, let us take the example of avocadoes. Usually, depending on how they look or feel when squeezed, suppliers and consumers access the ripeness. However, with the new hyperspectral imaging, the technology will be able to collect information from light the human eye cant see revealing its firmness and dry matter. This helps Apeel to frame a real-time prediction model for avocadoes red, yellow, green, from ripest to least ripe.

This first acquisition will facilitate the company in its plans of quantifying and digitizing produce quality data for its partners as well as for the entire global food system.

In a press release seen by Green Queen, CEO of Apeel, James Rogers, said: Our journey began with Apeels plant-based protection an invisible peel that addresses the challenge of global food waste by bringing more time to fresh produce before it spoils. Now, were expanding our technology to bring to light the previously invisible characteristics of produce, including internal quality, phytonutrient content, and environmental impact.

Were expanding our existing technology to bring to light the previously invisible characteristics of produce, including internal quality, phytonutrient content, and environmental impact

Given that its plant-based protection is in use throughout packing and distribution centers across North America, South America and Europe, the imaging technology will be added to the application systems to gather high-quality data images as the produce travels along the conveyance lines.

Founder of ImpactVision, Abi Ramanan, said that its companys technology can predict the internal quality of food products from hyperspectral images. When this ability to see beyond the borders of human vision is combined with Apeels shelf-life extension technology, the potential to fundamentally transform produce supply chains to reduce post-harvest loss, optimize distribution and lengthen shelf-life is enormous.

At the moment, 40% of the food grown globally goes to waste and hence, by continuously expanding into new produce categories and geographies, Apeel aims to collect category-wide datasets in a presently data-poor food landscape and by providing the largest and most comprehensive database of objective fresh produce insights aims to reduce food waste and strengthen the fresh fruit and vegetable supply chains.

When this ability to see beyond the borders of human vision is combined with Apeels shelf-life extension technology, the potential to fundamentally transform produce supply chains to reduce post-harvest loss, optimize distribution and lengthen shelf-life is enormous

For instance, fresh produce suppliers can use this data and know the exact ripening window for all their items, say if a produce supplier sees that an avocado is set to ripen tomorrow while another one will take 4 days to ripen, they know that one has more time to travel and should be sent to the retailer that is further away, ensuring that the best quality reaches consumers.

Presently, Apeel has 30 supplier integrations, with plans to double this number by end of this year.

Rogers added that using the insights made available through Apeels imaging technology, its partners will be able to effectively see inside of every fruit and vegetable. This will help quantify quality as never before so that the distribution of fresh food can be optimized. For our partners, this will mean less waste and an immediate bottom-line improvement, and ultimately, the ability to one day differentiate produce by making freshness and nutritional content visible to the consumer.

Elsewhere, China has introduced a new legislation to tackle food waste that bans online binge-eating videos and fines people that leave excess uneaten food in restaurants to enable a resource-conserving society.

Another company that is using its tech to enhance the shelf-life of products is Hazel Technologies, whose product offering is a sachet that releases shelf-life enhancing vapours in bulk produce cartons and recently received US$70 million in an oversubscribed Series C financing round to expand this technology.

Elsewhere, Barry Callebaut, which manufactures chocolate and cocoa products unveiled a sustainable brand Cabosse Naturals that is made from one single ingredient cacao which otherwise is wasted as only 30% of the entire pod is used in conventional products leading to unnecessary food waste.

Lead image courtesy of Apeel.

See the article here:

Sustainable Startup Apeel Acquires ImpactVision To Use Its AI Imaging Tech To Tackle Food Waste - Green Queen Media

DANBURY Summer Fun registration is now open; you can register in 4-H Online 2.0. If your child is not a 4-H member, please complete a profile, then you may register for Summer Fun Camps.

Join us for the 2021 Summer Fun day camp series where face-to-face opportunities for youth ages 5-18 are offered to actively create lasting summer memories through engaging activities. Become a Junior Master Gardener. Make tasty treats at Nutrition in the Kitchen. Become familiar with tree identification in Forestry for Beginners. Learn more about lambs and goats. There is something for everyone.

Junior Master Gardener Camp (June 8-10) For youth ages 5-18: Do you enjoy getting your hands dirty in the garden? Do you want to learn more about being a gardener? This program will introduce young gardeners to the art and science of gardening, while helping them develop life skills to become good citizens in their communities, schools and families. Join us from 9 a.m.-2 p.m. at the Stokes County Cooperative Extension office in Danbury. Bring your own lunch and something to drink.

Nutrition in the Kitchen Camp (June 14-16) For youth ages 5-18: Do you love being in the kitchen and cooking your favorite snacks or meals? Nutrition in the Kitchen will teach youth food and kitchen safety, and a number of recipes that they will be able to do on their own at home. Youth will gain cooking skills from their experience of being in the kitchen at this camp. Join us from 9 a.m.-2 p.m. at the Stokes County Cooperative Extension office. Bring your own lunch and something to drink.

Forestry for Beginners (June 29) For youth ages 5-18: There are trees all around us, but do you know what type of trees they are? The Stokes County Forest Service will teach us how to identify trees, identify the different parts of a tree and the function of each part. Join us on June 29 from 9 a.m. to 2 p.m. at the Stokes County Cooperative Extension office. Bring your own lunch and a drink.

Lamb and Goat Camp (June 30 & July 1) Youth ages 5-18: Learn all abaaaa-out taking care of sheep and goats. Well learn about being safe around animals, what sheep and goats eat, and even showmanship skills. We will end with a mock show for youth to showcase what theyve learned to their families. (Yes, youth will be working with live sheep and goats.) June 30 will be for youth ages 5-11 and July 1 will be for youth ages 12-18. Each day will be from 8 a.m. to noon for camp and 12:30-1 p.m. for the mock show, with a lunch break in between. (Please pay attention to which day youre signing up for so youre attending the correct age group.)

Cloverbud Camp (July 6-8) Youth ages 5-7: Calling all the Cloverbuds! If youre between the ages of 5-7 please join us! Youth will be learning all the basics to 4-H such as cooking, gardening and animal care, just to name a few. Each day we will focus on a different topic and youth will experience hands-on learning activities. Cloverbud Camp will be held from 9 a.m.-2 p.m. at the Cooperative Extension office. Bring your own lunch and something to drink.

Moooving Milk from the Farm to Table (July 15) Youth ages 8-12: How does milk end up on our tables? It doesnt just come from the grocery store. Come learn about the dairy industry and how milk moooves from the farm to the table. Were going to learn about the importance of nutrition for dairy cows, how to milk a cow, how cheese is made, and virtually tour a dairy farm. This camp will be held July 15 from 9 a.m.-2 p.m. and is geared towards youth ages 8-12 years old. Please bring your own lunch and a drink.

(Youth who are 5 years old must have completed Kindergarten or Pre-school.)

For more information visit: https://stokes.ces.ncsu.edu/stokes-county-4-h/2021-summer-fun/.

Originally posted here:

Cooperative Extension News - The Stokes News

Aluminum Foil Packaging Market with COVID-19 Impact by Component, Application, Services, and Region- Forecast to 2026

The Global Aluminum Foil Packaging Market Research Report 2021-2026 is a significant source of keen information for business specialists. It furnishes the business outline with development investigation and historical and futuristic cost analysis, income, demand, and supply information (upcoming identifiers). The Aluminum Foil Packaging market research analysts give a detailed depiction of the Market worth chain and Aluminum Foil Packaging wholesaler examination. The Aluminum Foil Packaging Market study gives extensive information which upgrades the agreement, degree, and use of this report. This is a latest report, covering the COVID-19impact on the Aluminum Foil Packaging market.

The aluminum foil packaging market was valued at USD 17.9 billion in 2020 and is expected to reach USD 24.18 billion by 2026 and work at a CAGR of 3.27% over the forecast period (2021-2026).

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Aluminum Foil Packaging Market 2021 Competitive Insights Amcor Limited, Zenith Alluminio Srl, Constantia Flexibles, Nicholl Food Packaging Ltd(Bawtry...

BOISE Spaulding Ranch, a historical but long inactive farmstead in the middle of Boise, will rise again, this time as a monument to the regions rich agricultural history.

The city of Boise is creating a park at the property that is also a farm.

The project is being built on 20 acres at the site of the historical Spaulding Ranch, a farmstead with a grand barn that has been preserved but not used for agricultural purposes for a quarter century.

The property is surrounded by subdivisions and is located off of North Cole Road, a busy transportation corridor.

Though the Settlers Canal still runs through the property, its heyday as a farmstead is long over. The city of Boise, with assistance from University of Idaho Extension employees who understand farming, plans to revive Spaulding Ranch.

Ada County has the second most farms in Idaho, behind Canyon County, although most of those farms are much smaller than the states average-size farm of 468 acres.

But agricultures presence within Boise, Idahos largest city, is virtually non-existent.

We want to restore this site so urban agriculture can still happen in Boise, said Lisa Duplessie, the project manager for the Spaulding Ranch project for Boise.

The revived Spaulding Ranch will be a nod to the areas agricultural history and a reminder to Boise residents that agriculture is still a major player in the states economy and way of life.

Boise Parks and Recreation staff will oversee the project and staff from University of Idaho Extension, given their farming expertise, will manage the agricultural operations at Spaulding Ranch.

The University of Idaho is a perfect and logical fit for us, given all the agricultural research they do, Duplessie said.

The city acquired the historical farmstead in 2016 as part of a land swap and citizens helped formulate a master plan for the property.

The master plan calls for the possibility of several agricultural-related features, including a six-acre demonstration farm, an orchard that includes apple, peach and pear trees, a small animal farm, pollinator gardens, farm-themed play equipment and a meadow maze.

The project could also include meeting and event space in a rebuilt barn, a community kitchen and farmers market.

The property will also include historical and current information about Idahos agricultural industry, which is responsible for one in every eight jobs in the state and 13 percent of Idahos gross state product, according to a recent U of I study.

What it will ultimately look like is still up in the air because there are so many possibilities, said Ariel Agenbroad, a University of Idaho Extension educator in Ada County.

The park-farm has already started to take form with the planting of 100 fruit trees in March. The idea is to begin planting crops in 2023.

It was super exciting to finally see stuff starting to happen, Duplessie said. This is a one-of-a-kind project. Its honestly a dream project.

The city worked with the community over the past three years to come up with a master plan of what the property could become, said Sara Arkle, the open space superintendent for Boise Parks and Recreation.

What weve heard pretty loud and clear is that people want to see urban agriculture done on this site, she said. They want to see orchards, they want to see veggie plots, they want to see agricultural education.

Boise was once a major part of Idahos agricultural community but its now by far the states biggest population center and farming and ranching havent existed within the city in any significant way in a long time.

As we become more of an urban area, its so much more important that were teaching our children where our food comes from and how its grown, Arkle said.

Besides being used to teach people about farming, a myriad of research and demonstration projects could take place on the six-acre demonstration farm site, Agenbroad said.

We could have a lot of really neat things happen there, she said. It will be a combination of research plots and actually engaging the public in farm training programs.

The city also plans to partner with 4-H programs to provide students a hands-on learning experience.

I am very, very excited about this project and its something that will be valuable to all youth in Idaho, said Allen Taggert, a 4-H Extension educator in Ada County. A property like this could really afford hands-on learning opportunities where kids can get their hands dirty and really understand what is going on in the world of agriculture.

While Boise residents obviously will get to enjoy the park-farm, the revived Spaulding Ranch property will be a real destination site for every Idahoan, Duplessie said.

Theres nothing else like this in the state, she said. Its within the city of Boise and a city project but Its really for everyone in the state to come and enjoy.

There is also almost unlimited potential for the project to develop, Duplessie added.

While theres a master plan for the project, the skys the limit, she said.

Read more:

Boise will revive Spaulding Ranch as a city park - Post Register

WILMINGTON, Del.--(BUSINESS WIRE)--Results from a new integrated analysis including data from the MELTEMI Phase III open-label extension trial showed FASENRA (benralizumab) was well-tolerated for up to five years, with a long-term safety profile consistent with previous Phase III trials in adult patients with severe asthma.

Results were presented today at the American Thoracic Society (ATS) 2021 International Conference.

During the period of the BORA and MELTEMI extension trials, adverse events (AEs) and serious adverse events (SAEs) did not increase from rates comparable to placebo observed in the Phase III pivotal trials. Rates of serious infection, hypersensitivity, immunogenicity, and malignancy were low across all treatment groups, with no deaths during the on-treatment window. The most commonly reported AEs during the open-label period for patients receiving FASENRA every eight weeks were nasopharyngitis, asthma, headache, and bronchitis. These data confirm FASENRAs well-established safety profile.

In secondary endpoints, FASENRA sustained the reduction in asthma exacerbation rates observed during predecessor SIROCCO, CALIMA, ZONDA and BORA Phase III trials with annualized asthma exacerbation rates (AAER) remaining consistently low over the five-year treatment period.

In patients taking high-dosage inhaled corticosteroids (ICS) with blood eosinophil levels of greater than or equal to 300 cells per microliter who received FASENRA every eight weeks, AAER decreased from 3.1 exacerbation/year pre-treatment to 0.5 in the predecessor studies with a further reduction to 0.2 by year four of the open-label trial. In the same treatment group 59% of patients experienced zero exacerbations during the four years of the open-label period (BORA and MELTEMI) and at least 75% of patients each year experienced zero exacerbations. In the final year of the trial 87% of patients experienced zero exacerbations.

Arnaud Bourdin, Head of Pulmonology, Professor of Respiratory Medicine at Arnaud de Villeneuve Hospital, Montpellier, France and primary investigator for MELTEMI, said: Clinicians treating severe eosinophilic asthma want to ensure the therapy they prescribe will continue to help patients control their illness in the long term, with a consistent safety profile. Based on the new MELTEMI data, physicians and their patients should feel confident that FASENRA provides a treatment option that can do exactly that reduce exacerbations, with a known safety profile.

Mark White, Global Franchise Head, FASENRA, said: The new data from MELTEMI are exciting as they confirm FASENRAs efficacy and safety profile seen in previously reported Phase III trials. These results should offer further confidence to physicians and patients that the positive outcomes theyre experiencing whilst using FASENRA can be maintained for the longer-term.

FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries and is approved for self-administration in the US and EU. The Food and Drug Administration (FDA) granted Orphan Drug Designation for FASENRA for eosinophilic granulomatosis with polyangiitis (EGPA) (November 2018), hypereosinophilic syndrome (HES) (February 2019) and eosinophilic oesophagitis (EoE) (August 2019).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONSKnown hypersensitivity to benralizumab or excipients.

WARNINGS AND PRECAUTIONSHypersensitivity ReactionsHypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.

Acute Asthma Symptoms or Deteriorating DiseaseFASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Reduction of Corticosteroid DosageDo not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) InfectionIt is unknown if FASENRA will influence a patients response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.

INDICATIONFASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

ADVERSE REACTIONSThe most common adverse reactions (incidence 5%) include headache and pharyngitis. Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.

USE IN SPECIFIC POPULATIONSA pregnancy exposure registry monitors pregnancy outcome in women exposed to FASENRA during pregnancy. To enroll call 1-877-311-8972 or visit http://www.mothertobaby.org/fasenra.

The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

Please read full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products by clicking here.

Severe asthmaAsthma is a heterogeneous disease affecting an estimated 339 million people worldwide. Approximately 10% of asthma patients have severe asthma. Despite the use of inhaled asthma controller medicine, currently available biologic therapies and oral corticosteroids (OCS), many severe asthma patients remain uncontrolled. Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for or respond well to a current biologic medicine.

Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced health-related quality of life. Patients with severe asthma are at an increased risk of mortality and have twice the risk asthma-related hospitalizations. There is also a significant socio-economic burden, with these patients accounting for over 50% of asthma-related costs.

MELTEMIMELTEMI is a multicenter, open-label safety extension, Phase III trial to assess the safety and tolerability of FASENRA administered subcutaneously in severe, uncontrolled asthma patients on ICS and long-acting beta2-agonists therapy with or without chronic OCS and/or other asthma controllers. Participants had completed one of three Phase III placebo-controlled predecessor trials (SIROCCO, CALIMA, ZONDA), then enrolled in the double-blind BORA safety extension trial, further transitioning into the MELTEMI open-label extension trial.

The integrated analysis results include patients who had received FASENRA for up to five years from the beginning of the treatment period in the predecessor studies. A total of 446 patients were included in the analysis. Of these, 384 (86.1%) completed the on treatment period and 16% were on treatment for greater than or equal to five years. Mean on treatment duration was equal to or greater than three years in each group. As typically observed in longer-term trials, due to the duration of time participants were followed, fewer patients continued through to the later stages of the study than completed the predecessor trials.

The primary endpoint in MELTEMI was FASENRA safety and tolerability, which was measured by rates of AEs and SAEs during the on-treatment period. The secondary endpoints included a subset of primary and secondary endpoints from the Phase III predecessor studies: annual asthma exacerbations, in-patient hospitalization, and/or an emergency department visit, absolute blood eosinophil counts over the course of the on-treatment period; and immunogenicity.

FASENRAFASENRA (benralizumab) is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death).

FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries, and is approved for self-administration in the US, EU and other countries.

FASENRA is in development for other eosinophilic diseases and chronic obstructive pulmonary disease. The US Food and Drug Administration granted Orphan Drug Designation for FASENRA for EGPA (November 2018), HES (February 2019) and EoE (August 2019).

FASENRA was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.

AstraZeneca in Respiratory & ImmunologyRespiratory & Immunology, part of BioPharmaceuticals, is one of AstraZenecas three therapy areas and is a key growth driver for the Company.

AstraZeneca is an established leader in respiratory care, and its inhaled and biologic medicines reached more than 53 million patients in 2019. Building on a 50-year heritage, the Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Companys early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Companys growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including Systemic Lupus Erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZenecas ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

About AstraZenecaAstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit http://www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

US-53643 Last Updated 5/2021

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New FASENRA Data From the MELTEMI Extension Trial Confirm Long-Term Safety and Efficacy in Severe Eosinophilic Asthma for up to Five Years - Business...

In last weeks expansionary budget, one area that felt a bit underdone was defence. Here, the government delivered what it promised 12 months ago: $44.6 billion, an increase over last years budget of 4.1% in real terms.

At any time in the last 25 years a defence budget growing at that level would have been welcome. But now Australia and the wider region faces the direst strategic outlook since perhaps the end of World War II.

Its clear that Scott Morison and his ministers understand that the region is facing a crisis brought on by an increasingly bellicose Chinese Communist Party. Taiwan is the immediate flashpoint and the level of risk will peak in perhaps four to five years time. In that period, according to the United States Defense Department, the Peoples Liberation Army will gain a strong military edge over the Taiwan Strait in air power, missiles and ships.

Would Xi Jinping risk his own future, as well as that of the CCP, to stage an attack on Taiwan? Xi has learned to turn risky situations to his advantage. In the illegal annexation of the South China Sea, in cyber spying and intellectual property theft, the imposition of communist authority in Hong Kong, and in the economic coercion of Australia, Xi took significant risks to strengthen his rule and largely got away with them.

He will apply the same strategy to Taiwan, using all means short of war and indeed some measures that cross that offensive line right up to the limits of US tolerance.

Ill come to what this might mean for Australia and for the defence budget soon, but first consider a remarkable phenomenon, which is the ability of so many in Australia to deny what is obvious about Beijings intentions.

Writing in the Australian Financial Review, former foreign minister Gareth Evans judged that no Chinese political or military preparations suggest an invasion is remotely imminent. That is an astonishing misjudgement.

On 24 April Xi presided over a ceremony commissioning three major warships for Chinas southern fleet. Communist party newspaper the Global Times declared: These vessels will play important roles in solving questions in places like the island of Taiwan and the South China Sea.

Hardly a day goes by without PLA aircraft, often in large numbers, encroaching Taiwanese airspace. CCP rhetoric about taking Taiwan by force if necessary is increasingly being used in speeches and editorials.

Xi will hope this show of strength will deter the US and the allies from stepping in and that his aims can be realised short of war, but we all need to understand that the risk of conflict is sharply growing.

In Washington last Thursday, US Secretary of State Antony Blinken and Foreign Minister Marise Payne held talks and gave a press conference, underlining the closeness of the alliance relationship.

The secretary of state stressed the Biden administrations interest in reaffirming and revitalizing Americas alliances and partnerships and, in the 70th year of the ANZUS Treaty, finding ways for the alliance to evolve to meet the challenges we face.

Blinken said the US will not leave Australia alone on the field, or maybe I should say alone on the pitch, in the face of economic coercion by China. Thats what allies do. We have each others backs.

Understand that the US has every expectation that the requirement for support runs in both directions. Washington wants Australia to do more, is telling us that the alliance needs to be revitalised and that challenges will be faced together.

This will include working out how to jointly respond to CCP belligerence over Taiwan, which wasnt mentioned once in the BlinkenPayne press conference. Sometimes you can judge the significance of an issue by the way it isnt mentioned publicly.

Back to the defence budget. The Morrison government has delivered everything that it has promised to do in the 2016 defence white paper and more, including two additional P-8 Poseidon maritime surveillance and anti-submarine warfare aircraft and four extra CH-47 Chinook heavy lift helicopters. There is also an accelerated plan to establish a missile manufacturing capability in Australia.

While these are positive steps, the uncomfortable truth is that the bulk of the $270 billion allocated over the coming decade to build ships, submarines and other military equipment will only come into service well after the riskiest period for Taiwan.

Defence Minister Peter Duttons most pressing challenge is to strengthen the Australian Defence Force in the shortest time frame possible. An immediate candidate will be to move quickly on the life extension and upgrade program for the Collins submarines. The government should also explore options to add yet more P-8s to the current 14 airframes but there are limits to what can be done quickly.

A faster way to strengthen deterrence would be to re-open a discussion with the US about increasing the US Marine Corps presence in northern Australia and getting some US Navy ships operating out of our west coast base, HMAS Stirling.

When the US marine presence was being negotiated a decade ago, the initial American offer was to deploy a 7,500-strong Marine AirGround Task Force. The Australian government of the day baulked, and instead we had a decade-long slow growth to the current annual contingent of 2,500.

A larger marine presence ultimately hinges on access to a port facility. Consider the thought that if Beijing wanted to slow down the growth of AustraliaUS defence cooperation in the Top End a clever way to do it would be to take control of the areas most viable port, which is exactly what happened in 2015 when Darwin Port was leased to a Chinese company for 99 years.

The world has fundamentally changed since then. Now, the opportunity to strengthen a shared US and Australian deterrent posture in the Indo-Pacific needs to be urgently reconsidered.

A conflict over Taiwan would be a disaster for all concerned, but disastrous conflicts happen all the time. At this point the best hope to keep the peace is to change Xis calculation about the level of risk China would face if it initiated such a crisis.

The only short-term way to strengthening deterrence is by lifting the defence readiness of democracies. If US President Joe Biden does visit Australia for the ANZUS anniversary, you can be assured this will be the number one item on his agenda.

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Defence spending and ADF readiness need to match the risk of conflict | The Strategist - The Strategist