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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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