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Companies that have developed a COVID-19 vaccine that is approved in the European Union will have to submit monthly safety reports during the pandemic to the European Medicines Agency (EMA), the agency said. Read More
The EMA’s outgoing head, Guido Rasi, welcomed Cooke as “a strong leader who is committed to steering EMA during this very challenging period.” Read More
The drugmakers also finalized an agreement with the European Commission this week to supply 300 million doses of their vaccine starting by year’s end. Read More
President Trump said Friday that his administration is “working to secure an Emergency Use Authorization” from the FDA for Pfizer’s vaccine candidate for COVID-19 and that it will be available to the general population for free “as soon as April,” but will be withheld from states like New York whose governors have expressed qualms about a vaccine approved by the FDA under the current administration. Read More
The Senate Appropriations Committee has released the draft of a bill that would grant the FDA $3.2 billion in fiscal 2021 funding — an amount that mirrors what the House allocated in July and is in line with the Trump administration’s budget request for the agency. Read More
Democrats in both the House and Senate have penned letters to the Department of Justice protesting its $8.3 billion settlement with Purdue Pharma that would see the beleaguered opioid maker become a public benefit company as it emerges from bankruptcy over its role in the opioid crisis. Read More
The head of the Butantan Institute, which is leading the trial, does not believe the adverse event is related to the vaccine, Sinovac claims. Read More
The UK’s National Institute for Health and Care Excellence (NICE) is considering changes to how it evaluates the cost-effectiveness of medicines and is inviting public comment. Read More
Rick Bright, who was leading the vaccine effort at NIH’s Biomedical Advanced Research and Development Authority (BARDA) but was pushed aside by the Trump administration, has joined President-Elect Joe Biden’s Transition COVID-19 Advisory Board. Read More
As Novavax gears up to put its investigational COVID-19 vaccine through a phase 3 U.S. trial this month, the FDA has granted the candidate a Fast-Track designation in order to speed up its regulatory review process. Read More