WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Everyone wants to know what’s coming next. FDA chief Stephen Hahn was summoned to the White House this week to explain the agency’s timeline for reviewing Pfizer and BioNTech’s COVID-19 vaccine. Meanwhile, Anthony Fauci slammed the U.K.’s speedy approval of the shot, saying moving too quickly could lose the public’s trust. Moderna also submitted its mRNA-based vaccine to the FDA, which scheduled it for an open advisory committee meeting Dec. 17, seven days after Pfizer’s next Thursday. And elsewhere, AstraZeneca staff were targeted by North Korea in a hacking scheme aimed at COVID-19 research. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Eric Sagonowsky Throughout the pandemic, White House officials have twisted arms at the FDA—and sometimes succeeded. Now, in the final months of the Trump administration, agency chief Stephen Hahn, M.D., has been summoned to explain why FDA hasn't authorized Pfizer's vaccine yet, Axios reports. read more |
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Top Stories Of The Week By Nick Paul Taylor The U.K. government has asked the national regulator to consider clearing AstraZeneca’s COVID-19 vaccine for temporary supply as soon as it receives safety, quality and efficacy data. Requesting use of the fast track positions the U.K. to be among the first countries to begin a COVID-19 vaccination campaign. read more By Angus Liu Some AstraZeneca staffers may have thought they were talking to corporate recruiters on LinkedIn and WhatsApp, but these job offers were merely fabricated by North Korean hackers as part of a scheme to breach its computer systems and steal COVID-related research, Reuters reported. read more By Fraiser Kansteiner Pfizer, alone among its peers, has faced fever-pitch scrutiny over the stringent cold storage requirements for its COVID-19 vaccine—and the logistical challenges that could pose. Looking to ease the doubters' concerns, Pfizer has now shipped its first doses by air to the U.S., and distributors are watching closely. read more By Ben Adams As Moderna continues to drip-feed the latest data from its late-stage COVID-19 vaccine effort, it has updated the shot’s efficacy figure. read more By Eric Sagonowsky The U.K.’s monumental approval for Pfizer and BioNTech’s COVID-19 vaccine turned heads worldwide, but one of the leading voices in the U.S. pandemic response argues the country’s regulators acted too quickly. read more By Nick Paul Taylor Biogen is paying $1.5 billion upfront for a stake in Sage Therapeutics’ once-failed depression therapy zuranolone and an earlier-phase asset. The agreement gives Biogen rights to a drug that is closing in on data from three late-phase trials that will shape its future. read more By Kyle Blankenship With two players in the race for a COVID-19 vaccine nearing the finish line on world-first regulatory approvals, Maryland biotech Novavax continues to lag behind in getting its candidate into a late-stage trial in the U.S. Now, that trial has been pushed back further as the FDA targets its manufacturing plans. read more By Conor Hale After a brief stint in the antidote business, Boston Scientific has moved to hive off the specialty pharmaceuticals division it picked up through last year’s $4.2 billion acquisition of the British oncology devicemaker BTG. A new, $800 million cash deal will transfer the entire operation to the European pharma group Serb. read more By Arlene Weintraub Researchers at the Centre for Genomic Regulation in Barcelona are developing a stem cell treatment for retinal degeneration that focuses on two chemokine receptors that play an important role in cell signaling. The altered cells migrated in high numbers to degenerating retinal tissue and preserved its function, they reported. read more By Beth Snyder Bulik The FDA and American Association for Cancer Research debuted Project Livin’ Label, an educational program that explains new oncology drug approvals in videotaped sessions with experts. The premiere episode focuses on Seagen's metastatic breast cancer drug Tukysa. read more Enrollment Showcase | Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper |
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| Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand. |
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Resources 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: Cytiva Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand. 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: Veeva New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress. 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: Thermo Fisher Scientific One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline. 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. | 
