WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Though an FDA advisory panel gave its long-awaited blessing to Pfizer and BioNTech’s COVID-19 vaccine yesterday, top executives in the race say an agency green light will be just the beginning. In the months ahead, Pfizer, Moderna and J&J will need to scale up their manufacturing lines and establish equitable and ethical schemes to deliver their shots across the country. At the same time, new data this week from Moderna raised hopes, while Pfizer’s side effects have raised some flags—but not enough to sink its chances, analysts say. The immediate goal, according to Operation Warp Speed’s Moncef Slaoui, is to begin shipping doses within 24 hours of FDA authorization, and within 48 of the all-clear from the agency’s vaccine committee. | |
|
Featured Story | By Fraiser Kansteiner The next challenge drugmakers will face after a COVID-19 shot snares approval? Distribution and access, top execs from Pfizer, Moderna and Johnson & Johnson told NBC News. Making sure those shots reach communities of color, disproportionately hit by the virus and underserved by the healthcare system, is one major concern, the execs said. read more |
| |
|---|
|
Top Stories Of The Week By Nick Paul Taylor Antibody levels stayed elevated in the 90 days after people received the second dose of Moderna’s COVID-19 vaccine, raising hopes that the prophylactic can provide protection for one year. read more By Nick Paul Taylor Eli Lilly’s tirzepatide has significantly reduced blood sugar and body weight in Type 2 diabetics in a late-phase clinical trial. The release of the top-line data provides early validation of Lilly’s decision to place a big bet on the dual GIP/GLP-1 agonist. read more By Arlene Weintraub A few surprises cropped up in FDA documents released ahead of an advisory committee meeting on Pfizer's COVID-19 vaccine candidate, including some side effects reported in the phase 3 trial. They'll trigger discussion at Thursday's confab, but not enough alarm to prevent a quick emergency authorization, analysts predicted. read more By Kyle Blankenship With the first regulatory approval for a COVID-19 vaccine under its belt, Pfizer is gearing up for the global launch of its mRNA-based vaccine—and with the world watching and other competitors in the wings, any rollout hitch could be a bad omen for Pfizer's investors. Like a supposedly sudden revision to its distribution plan, for instance. read more By Conor Hale Researchers in California aim to develop a new CRISPR-based test for COVID-19 that can be read anytime, anywhere, by turning a basic smartphone camera into a microscope capable of detecting the coronavirus’ genetic material. read more By Ben Adams Canada’s speedy R&D engine AbCellera, now world-renowned for its tech producing the Eli Lilly COVID-19 drug authorized by the FDA, has set terms for a monster IPO. read more By Carly Helfand Johnson & Johnson and AbbVie’s Imbruvica currently reigns supreme in the previously untreated chronic lymphocytic leukemia market. But newer members of its class are threatening, and both of them put up data in other cancer types that might catch the attention of CLL prescribers down the line. read more By Arlene Weintraub Many people with Alzheimer’s start to suffer a loss of the brain’s white matter—a key regulator of cognition—long before their disease is diagnosed. A research team led by Case Western Reserve showed in mice that eliminating the protein Drp1 can halt this decline, and it's developed a drug that regulates the protein. read more By Sharon Klahr Coey Novartis wants to help patients overcome the hurdles in specialized eye disease treatment with the help of a new digital tool. The Swiss drugmaker worked with disease management app company smartpatient to create an educational module specifically for wet age-related mascular deneration to help patients better understand and manage their condition. read more Resources 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: 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: 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. | 
