| | 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! |
Regeneron seeks EUA for COVID-19 antibody as Trump vows to provide it for 'free' Azar lays out optimistic COVID-19 vaccine timeline of 100 million doses by end of 2020 AstraZeneca puts a time limit on its COVID-19 'no-profit' pledge: report Moderna won't enforce COVID-19 vaccine patents during pandemic FDA warns PPE decontamination manufacturer over lack of process for reporting adverse health events J&J inks European COVID-19 vaccine supply deal for 200M doses New U.K. report shows up 'precarious' nature of restarting non-COVID-19 research Pfizer, BioNTech bring on Germany's Rentschler for purification of mRNA-based coronavirus shot This is the presidential candidate more healthcare execs believe would be better for the industry: survey Biopharma roundup: Eli Lilly's Olumiant helps patients on oxygen; Vaccine in 2020 'unlikely,' European regulator says Gilead Sciences sends additional doses of COVID-19 therapy remdesivir to EU amid shortages Featured Story | By Nick Paul Taylor Regeneron has filed for FDA emergency use authorization of its COVID-19 antibody cocktail. President Donald Trump, who received REGN-COV2 after catching the virus, said he has “emergency use authorization all set” and will make the antibody cocktail available for “free.” read more |
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Top Stories By Robert King HHS Secretary Alex Azar laid out an optimistic timeline for the approval and distribution of a COVID-19 vaccine, but stopped short of promising approval before election day. read more By Arlene Weintraub AstraZeneca has pledged it won't try to profit off its COVID-19 vaccine during the pandemic phase of the disease. But it could declare the pandemic has ended as early as July of next year, according to a reported agreement with a manufacturer. read more By Eric Sagonowsky Moderna, a biotech advancing one of the leading COVID-19 vaccine candidates, has faced questions for several months over its patents and intellectual property. Responding to investor questions, the company now says it won't enforce its vaccine patents against other companies during the pandemic. read more By Robert King The Food and Drug Administration sent a warning letter to Battelle Memorial Institute over its system for decontaminating PPE, asking for information on how the institute will report adverse health events to the agency. read more By Eric Sagonowsky Two months after concluding exploratory talks over a COVID-19 vaccine supply pact with officials in Europe, Johnson & Johnson has finalized its deal. The company will provide 200 million doses of its vaccine—should it prove safe and effective in testing and win an approval—for an undisclosed price. read more By Ben Adams A new report out this week shows that the U.K. “has been leading the rest of Europe in early stage clinical research,” but the recovery for non-pandemic trials is on a knife-edge. read more By Kyle Blankenship Pfizer and BioNTech are in the home stretch for a late-stage clinical trial of their mRNA-based COVID-19 vaccine with data expected next month. But as logistical challenges dog the partners' prospects, a German manufacturer is jumping on board to help lighten the load. read more By Tina Reed In a survey provided first to Fierce Healthcare by Advis, executives also weighed in on the potential changes they'd expect under a Trump-Pence administration compared to a Biden-Harris administration. read more By Eric Sagonowsky, Angus Liu, Kyle Blankenship, Conor Hale, Fraiser Kansteiner After Eli Lilly unveiled positive findings for rheumatoid arthritis drug Olumiant in combination with Gilead's remdesivir, the company touted new findings Thursday. Meanwhile, a COVID-19 vaccine approval in 2020 remains "unlikely," the head of Europe's drug regulator told Bloomberg. Plus the latest headlines from HHS secretary Alex Azar, NIH and Anthony Fauci. read more By Kyle Blankenship As one of few COVID-19 therapeutics with global regulators on board, Gilead Sciences' remdesivir saw immediate U.S. demand that has somewhat tapered off in recent months. But in the EU, some nations have seen spot shortages, and Gilead is stepping in with more supply. read more | 