WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST While the president has repeatedly said a vaccine could be available before the Nov. 3 election, new developments have all but closed that window. Operation Warp Speed’s Moncef Slaoui outlined a timeline for data drops beginning in late November through 2021, with Pfizer and Moderna expected in the first wave—while Moderna CEO Stéphane Bancel said it’ll be Nov. 25 at the earliest before they can deliver the goods to the FDA. Meanwhile, BioNTech and Pfizer have begun a rolling submission of their vaccine to the European Medicines Agency, and Eli Lilly is hustling its antibody treatment to FDA reviewers. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Eric Sagonowsky In recent weeks, COVID-19 vaccine timelines and expectations have increasingly become clearer. Moderna, a leading player, doesn’t expect to be able to file for an emergency use authorization until late November, its CEO told the Financial Times. read more |
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Top Stories Of The Week By Nick Paul Taylor BioNTech and Pfizer have started a rolling submission of their COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA). The news comes days after EMA named AstraZeneca's AZD1222 as the first COVID-19 vaccine to start the rolling review process. read more By Eric Sagonowsky President Donald Trump has repeatedly said a COVID-19 vaccine could be available around the election, but developments in recent days have all but nixed that possibility. Instead, officials are signaling a timeline of data releases that begins in November and continues into 2021, with emergency reviews along the way. read more By Ben Adams Eli Lilly is hustling to the FDA with its antibody therapy for a speedy emergency use authorization as it also reveals new data for a combo therapy. read more By Ben Adams After seven years running Merck’s R&D engine, much of which has revolved around cancer blockbuster Keytruda and, now, COVID-19 vaccines, Roger Perlmutter, M.D., Ph.D., is hitting the exit. read more By Angus Liu Gilead's remdesivir is one of only a few drugs to show benefits in COVID-19. After a somewhat chaotic initial rollout by the U.S. government and a drop in demand since, the company is now taking distribution of the antiviral into its own hands. read more By Beth Snyder Bulik Just days after Regeneron published early data on its COVID-19 antibody cocktail, the White House announced that President Donald Trump was taking it. What followed was a run-up in Regeneron shares, repeated shout-outs from the president and a fair share of media appearances for the company's already high-profile execs. read more By Amirah Al Idrus The first data are in for Regeneron’s COVID-19 antibody cocktail—and they’re encouraging. The top dose of the treatment lowered virus levels and relieved symptoms more quickly than placebo in patients infected with COVID-19 but not sick enough to be hospitalized. read more By Conor Hale Quidel snagged an FDA emergency authorization for what it describes as a rapid “ABC” test—a 15-minute, point-of-care diagnostic for influenza A, influenza B and COVID-19—as experts raise alarms about a potential "twindemic" this winter. It's the latest pandemic move for Quidel, which tripled third-quarter sales thanks to its Sofia-2 antigen test. read more By Kyle Blankenship In the months since the FDA identified a probable carcinogen in tested lots of generic diabetes med metformin, the list of companies pulling their versions off U.S. shelves has continued to grow. Now, an Indian firm is dramatically expanding an earlier recall to include a vast swath of its version of the drug. read more By Arlene Weintraub In some forms of retinopathy, blood vessels grow out of control in the eye, blocking light and causing irreversible vision loss. An experimental small molecule blocked proteins in the eye that cause the vessels to grow out of control, and in mouse models it tamped down their growth while leaving healthy blood vessels alone. read more Resources Sponsored By: The PerkinElmer Signals Screening Team Creating integrated HCS workflows in a single platform increases accuracy; reduces time and helps to identify the most appropriate hits or drug candidates. Learn more about a reliable method for creating a more efficient, faster, 3D image and multi-parametric data analysis workflow. Sponsored by: EVERSANA An integrated compliance model can be the competitive differentiator to commercialization and move the needle from cost center to value. Learn How. 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: LabVantage Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions. 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Sponsored by: 4G Clinical This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials. 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: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. 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. | 
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