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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

Eli Lilly kicked off a phase 3 trial of its protective antibody treatment, and is enrolling the residents of nursing homes, which have been the locus connecting more than 40% of all U.S. deaths due to COVID-19. Meanwhile, Sanofi and GlaxoSmithKline picked up $2.1 billion in Warp Speed vaccine development money, as Pfizer and BioNTech set up a 120 million-dose deal in Japan. Elsewhere, the industry could be entering a “golden age” for biosimilars, as copycat makers post big financial gains this year. Those stories plus our top reads of the week follow below.

Featured Story

Pfizer, Amgen will rake in billions during ‘golden age’ for biosimilars: Analyst

There may be a lot of competition in the U.S. biosimilars market, but Amgen and Pfizer are well positioned to dominate, Bernstein analysts predicted in a new report. That's because attractive pricing in the U.S. versus overseas markets makes up for market-share shortfalls, they explained.

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Top Stories Of The Week

Lilly starts phase 3 test of COVID-19 antibody in nursing homes

Eli Lilly has started a phase 3 trial to evaluate whether its antibody LY-CoV555 stops the residents of nursing homes from developing COVID-19. Lilly has created customized mobile research units to run the clinical trial at nursing homes as the long-term care facilities lack experience running studies. 

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With AstraZeneca deal, Wockhardt joins U.K.'s coronavirus vaccine manufacturing push

Mumbai, India-based pharma Wockhardt has signed up for fill-finish duties on AstraZeneca's Oxford-partnered COVID-19 shot, using a manufacturing site in Wales. It's setting aside capacity there for other candidates as well, as part of a broader deal to build out U.K. stores of vaccine hopefuls.

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Struggling Redx out-licenses fibrotic asset to AstraZeneca, sees stock sky rocket

AstraZeneca is picking up a delayed preclinical fibrosis candidate from Redx in a deal that gives the U.K. biotech a much needed cash boost which also saw its shares sky rocket.

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Top vaccine players Sanofi, GSK win $2.1B Warp Speed funding for COVID-19 shot

Sanofi, already working with BARDA on a GlaxoSmithKline-partnered COVID-19 vaccine, has won further support from the U.S. government—this time, to the tune of $2.1 billion for clinical development and delivery of 100 million doses. It's a hefty bet, but on a proven vaccine technology from two of the biggest vaccine makers in the business.

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U.K. antibody test approved to support government's free coronavirus screening efforts

A coalition of U.K. research institutions and diagnostic developers backed by the British government has secured regulatory clearance to move ahead with their hand-held antibody blood test for COVID-19.

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Priming HER2 breast cancer with a vaccine to improve PD-1 inhibition

Scientists at Duke University showed that priming the immune system with a vaccine targeting an oncogenic variant of HER2 helped existing checkpoint inhibiting drugs work better in mouse models of HER2-positive breast cancer. A phase 2 clinical trial testing the theory is already underway.

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Pfizer, BioNTech keep COVID vaccine deals rolling with 120M-dose Japan pact

Pfizer and BioNTech recently snared $1.95 billion from the U.S. to deliver 100 million doses of their leading COVID-19 vaccine candidate, and before that, the partners inked a supply pact with the U.K. Now, they've agreed to deploy 120 million shots to Japan by the first half of 2021, in that country's first major vaccine pre-purchase.

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Novartis’ Ilaris unexpectedly slashes need for joint replacements from osteoarthritis in key study

Novartis has been laboring for the last few years to expand the market for Ilaris, a drug that’s currently approved to treat a few rare inflammatory diseases. Now it has data from a 10,000-patient trial showing that people with osteoarthritis taking the drug had 40% to 47% lower rates of total knee or hip replacements than did those taking a placebo.

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Amarin spurns would-be marketing partners to launch Vascepa in Europe on its own

Amarin's wild 2020 ride continues. The company rolled out second-quarter numbers weighed down by COVID-19, but unveiled plans to launch Vascepa in Europe without a bigger marketing partner. That's on top of preparing to appear in appeals court this fall to try to salvage Vascepa's key patents.

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Resources

Whitepaper: More Powerful Analytics Capabilities

Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI.

eBook: Navigating the Insulin Affordability Act

Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Whitepaper: How to find today's TOP emerging market trends via medical claims data

Pharma marketing ROI soars when powered by claims data insights.

Whitepaper: High-Loaded Dosage Forms: Novel Platform Expands Spray-Dried Dispersion Utility

A novel spray-dried dispersion platform has been developed to faciliate high drug load applications

Executive Summary: Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

Presentation: Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

Executive Summary: Strategies for Flexible Manufacturing

This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market.

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study.

eBook: Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study.