WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Moderna’s mRNA vaccine continues to speed toward authorization and nationwide distribution, after collecting endorsements from the agency’s reviewers and advisory panel this week. But coming in second place after Pfizer and BioNTech’s shot is far from a consolation prize—the country needs every dose it can get to supply a massive immunization campaign, especially since clinical data from Sanofi and GSK may push their vaccine to mid-2021. And besides, with Pfizer’s international stock already spoken for, the U.S. government has doubled its order with Moderna, to 200 million total doses for an extra $1.68 billion. Those stories, plus our top reads of the week, follow below. | |
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Featured Story | By Amirah Al Idrus Moderna’s COVID-19 vaccine is checking the boxes en route to an emergency nod. FDA staffers endorsed the shot as safe and effective in briefing documents published (PDF) on Tuesday, ahead of a COVID-19 vaccine advisory committee meeting scheduled for Thursday. read more |
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Top Stories Of The Week By Fraiser Kansteiner The U.S. government snapped up 100 million more doses of Moderna’s COVID-19 vaccine candidate, boosting supplies ahead of a potential FDA authorization later this week—and after officials struck out in procuring additional shots from Pfizer before next summer. The mRNA specialist plans to deliver all 200 million doses now pledged to the U.S. by the second quarter of next year. read more By Angus Liu Just when Gilead's $21 billion acquisition of Immunomedics looked to be 2020's biggest biopharma deal, AstraZeneca came up with an even larger one—and it involves one of the industry’s top takeover targets, Alexion. But one analyst argues the British pharma isn't paying enough for a "scarce and high-quality asset." read more By Nick Paul Taylor Sanofi and GlaxoSmithKline’s COVID-19 vaccine has failed to trigger the desired immune response in people aged 50 years and older, forcing the partners to rethink the antigen formulation. The setback is expected to delay the availability of the vaccine from mid-2021 to near the end of next year. read more By Fraiser Kansteiner Newly minted Viatris‚ a marriage of Pfizer's Upjohn unit and generics giant Mylan, is plotting thousands of post-merger layoffs. The company plans to close, sell or shrink up to 15 global manufacturing facilities in a move that could hit 20% of the company's workforce, translating to some 9,000 jobs on the line. read more By Angus Liu The respiratory airway, as the primary entry point of the novel coronavirus, could be a good target for delivery of drugs that aim to protect people against the disease. An antibody nasal spray designed by Eureka Therapeutics protected mice against the virus for at least 10 hours, even at the lowest concentrations tested. read more By Eric Sagonowsky Even as headlines raised alarms about coronavirus breaking out in the U.S. early this year, many events still went on—and Biogen's February management conference was one calamitous example. Just how calamitous? Researchers have now linked the event with hundreds of thousands of U.S. cases. read more By Arlene Weintraub Even amid setbacks at the FDA, biopharma companies have been improving gene therapies to treat rare diseases like PKU, Fabry and gangliosidosis, with advances that range from new gene-insertion methods to technologies that can get the treatments to hard-to-reach areas of the body. read more By Angus Liu Novartis’ Entresto chalked up a high-profile flop in a heart failure study last year, but the Swiss pharma shot for an FDA approval anyway. Now, reviewers at the agency appear to be rooting for the drug even at the expense of a gold-standard statistical bar. read more By Ben Adams Medtronic is shifting its C-suite after its cardiovascular portfolio lead and 11-year veteran Mike Coyle jumps ship at year-end to run wearable electrocardiogram maker iRhythm Technologies. read more Resources Sponsored By: Metabolon Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline. Sponsored by: ZS Learn how Aerie fueled their product launches with advanced analytics. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Thermo Fisher Scientific Lack of resources to move from lab concept to the manufacture/delivery of GMP clinical supplies to patients, key milestones can be missed. Sponsored by: Covance Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: BBK Worldwide The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement. Sponsored By: BioAnalytix Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics. Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Sponsored By: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. 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: 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: 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: 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. | 