WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST AstraZeneca is amassing vaccine partners, with eyes on producing 2 billion doses per year to inoculate the world against COVID-19. With a candidate from Oxford, the Big Pharma has been pushing supply deals with Daiichi Sankyo to bring the vaccine to Japan, and with the government of Brazil, where the outbreak is surging. In the U.S., the FDA said any approved vaccine must be at least 50% effective against the coronavirus—on par with a flu shot in a good year. But others think they can make a homegrown vaccine, themselves. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Kyle Blankenship AstraZeneca has picked up manufacturing partners at a rapid clip with a goal to produce 2 billion doses per year of the University of Oxford's COVID-19 vaccine candidate. And it may be close to adding to that partner list: The British drugmaker and Daiichi Sankyo are in talks to knock together a supply deal for Japan. read more |
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Top Stories Of The Week By Ben Adams When you spend $63 billion on a company, your hope is that investment will come back; sometimes, however, you get hit with problems. read more By Nick Paul Taylor A second patient has died after receiving Audentes Therapeutics’ gene therapy against a rare genetic neuromuscular disorder. Audentes, which Astellas Pharma acquired for $3 billion, has dropped plans to file for approval imminently and paused a clinical trial while it reviews the situation. read more By Beth Snyder Bulik After months of waiting, Gilead’s pricing for COVID-19 treatment remdesivir inspired the backlash many expected. Patient advocacy groups and legislators howled over the $3,120 price tag as greedy and excessive, while analysts and even an industry watchdog pegged the price as acceptable—and in some cases, lower than expected. read more By Eric Sagonowsky Coronavirus vaccine developers now have some advice from the U.S. FDA. To win an approval, any vaccine must be at least 50% more effective than placebo in preventing the disease, the WSJ reports, citing guidance to be presented today. That's about as effective as a flu shot in a good year—but it falls short of some expert recommendations for arresting the virus' spread. read more By Amirah Al Idrus While governments inject cash into a COVID shot, one DIY vaccine maker thinks he can beat biopharma to the punch—and he'll start by injecting himself. Nevermind that companies like Moderna and AstraZeneca are racing vaccine candidates into and through the clinic at unprecedented speeds with plans to bring vaccines to Americans this year. read more By Arlene Weintraub Antivirals from Roche, Bristol Myers Squibb, Viiv and Gilead, or modified versions of them, could prove effective against COVID-19, reported researchers from Columbia University and the University of Wisconsin-Madison. What's key is their ability to disrupt a protein called polymerase. read more By Angus Liu Pfizer’s rare heart disease med Vyndaqel, at $225,000 a year, is too pricey for many patients. To help Medicare participants afford the expensive drug—and maintain its hefty sticker price—the Big Pharma is going so far as to argue the U.S. government’s anti-kickback policy is unconstitutional. If it succeeds, pharma would escape some rules it's chafed against for years. read more By Eric Sagonowsky Novartis has faced years of investigations into bribes paid to doctors in Greece, and this week, the company inked a $347 million deal with U.S. authorities to put the issue to rest. In a new deferred prosecution agreement, the DOJ lays out details behind the scheme and the company's efforts to conceal its illicit payments. read more By Conor Hale New data from a three-year registry of more than 2,500 international patients with uncontrolled high blood pressure showed real-world improvements in their numbers following treatment with Medtronic’s Symplicity renal denervation system, regardless of any medications they were taking. read more Resources Sponsored by: PRA Health Sciences Collaboration across the industry will be key to meeting the demands of the RACE Act and ensuring pediatric patients receive the care and treatments they need. Sponsored by: Systech Get an inside look… Merck shares its next-generation approach to supply chain protection with new digital platforms, including Blockchain. Sponsored by: Automation Anywhere Built on advances in Artificial Intelligence (AI), data mining, and information integration into various systems at 100% accuracy, the new era of intelligent automation is integral to life sciences for devising new treatments faster and at a lower expense. Sponsored by: Research Solutions Learn four ways to squeeze more value from your limited R&D resources. Sponsored by: BioAnalytix Download this eBook and Learn the Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies Sponsored by: Blue Matter, strategic consultants in the life sciences White paper describing 7 keys to success for any biopharma company that is entering (or thinking about entering) Europe. Sponsored by: Catalent 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. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent 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. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent 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. Sponsored by: Catalent 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. | 
