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. | |
| 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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| | Webinar: Digitize Remote Site Monitoring with Box Tuesday, October 13 | 2pm ET / 11am PT Fierce Pharma is teaming up with Box to discuss how your life sciences organization can continue to propel therapies & devices through the value chain with faster and even more secure site monitoring and auditing. Accelerate R&D processes across the value chain, maintain GxP compliance and reduce your overall IT footprint. Save your spot! | 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. 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