WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Pfizer made it clear that it won’t need federal help to distribute up to 100 million doses of its COVID-19 vaccine, once it’s authorized by the FDA, saying it will use its own system instead of the government’s chosen partner McKesson. Elsewhere, Regeneron’s antibody cocktail was hit with a safety signal, with an independent data monitoring board telling the company to stop enrolling the sickest patients. And recently this week, FDA reviewers said Biogen’s aducanumab data were “highly persuasive,” in briefing documents for an agency committee gathering to discuss the fate of the controversial Alzheimer’s drug. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Arlene Weintraub If Pfizer's COVID-19 mRNA vaccine is approved, it will not use the government’s chosen distribution provider, McKesson Corp., but rather its own just-in-time system to deliver it, a top executive said. The need to keep the vaccine at an ultra-cold temperature is one reason for that choice. read more |
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Top Stories Of The Week By Ben Adams The saga of COVID-19 antibody R&D continues as the REGN-COV2 antibody cocktail used by President Donald Trump and touted as a cure has been hit by safety worries as it continues to push for an FDA emergency authorization. read more By Fraiser Kansteiner Lonza is plowing ahead in the COVID fight with production work on Moderna's mRNA-based vaccine and Humanigen's monoclonal antibody lenzilumab. Now, it's signed on to manufacture AstraZeneca's dual-antibody hopeful, AZD7442, too. read more By Nick Paul Taylor AstraZeneca has a good chance of delivering late-phase data on its COVID-19 vaccine this year, the chief investigator of the Oxford Vaccine Trial said. The timing gives AstraZeneca a “small chance” of being able to start distributing the AZD1222 vaccine in the U.K. before Christmas. read more By Conor Hale By casting a broad, digital net to pick up the signs of coronavirus outbreaks, researchers hope to build an early warning system that uses data from people’s wearable activity trackers. read more By Eric Sagonowsky Gilead Sciences has the most successful COVID-19 drug so far in Veklury, an antiviral also known as remdesivir that was originally developed as part of research programs into hepatitis C and respiratory syncytial virus. While there’s an ongoing debate about the med’s efficacy against the novel coronavirus, the drugmaker is already reeling in big sales in the indication—and has also gained an added benefit it doesn't deserve, a patient advocacy group argues. read more By Ben Adams A drug that was very nearly culled and needed some serious data digging to find glimmers of efficacy has been broadly backed as “highly persuasive” from the FDA’s briefing documents out Wednesday morning. read more By Angus Liu Fifteen months since the deal announcement, Mylan and Pfizer can finally move ahead with their generics merger after a COVID-related delay and a closer examination by U.S. antitrust regulators that has now ended with a settlement for product selloffs. read more By Angus Liu All public attention for Pfizer these days is centered on its BioNTech-partnered COVID-19 vaccine. But while key phase 3 efficacy data for the experimental shot remain blinded, the company’s tafamidis franchise is cruising on a clear growth trajectory that now looks sure to take it to blockbuster status. read more By Angus Liu Existing immuno-oncology therapies primarily leverage adaptive immunity to fight cancer. A research team led by scientists at the Icahn School of Medicine at Mount Sinai has discovered a possible way to tap the innate immune system, using a nanobiologic to boost the effectiveness of checkpoint inhibitors in mice. read more Resources Sponsored By: Medidata Responding to site challenges. Approaching virtualization. Leveraging real-time data. Medidata shares 8 parameters to implement your virtualization strategy during COVID-19 and beyond. Download Now. Sponsored By: WCG Need additional site resources for your current or upcoming clinical trial? Sponsored By: AmerisourceBergen How pharma's supply chain partners are paving the way for coronavirus therapies. Sponsored By: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. Sponsored By: Thermo Fisher Scientific Anticipate early development challenges to avoid rework and costs. Sponsored By: Cytiva Accelerating the production of viral-vector based therapy requires both understanding of strategies to address viral vector manufacturing and how to select the most cost-effective solution for your therapeutic. Read more in this article. Sponsored by: LexisNexis Risk Solutions Get insights into healthcare decision-makers networks. Sponsored By: Veeva Learn how to plan immersive digital event experiences Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Cascade Chemistry, API CDMO Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Formedix Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Catalent 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. 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. | 