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The U.S. will have 300 million or more surplus COVID-19 vaccine doses by the end of July, a stockpile that could and should be shared with countries in need to reduce uneven vaccine distribution, says former FDA Commissioner Mark McClellan and the co-authors of a new report. Read More
The FDA has published additional minutes from its talks with industry on PDUFA VII, detailing two January meetings centered on review process improvements. Read More
The UK’s National Institute Health and Care Excellence (NICE) has released a new five-year plan to accelerate patient access to new treatments as it moves forward independently of the EU’s regulatory authority now that the UK has fully separated from the bloc. Read More
A California lawsuit against Johnson & Johnson (J&J), Teva Pharmaceuticals, AbbVie’s Allergan and Endo International, charging the companies with fueling the nation’s opioid epidemic, got under way yesterday, marking only the second such lawsuit to go to trial. Read More
The EU has exercised its option to purchase 100 million additional doses of Pfizer/BioNTech’s two-dose COVID-19 vaccine, putting the trade bloc in line to receive 600 million shots in total this year as it clamors for additional supplies to boost its vaccination efforts. Read More
Emergent BioSolutions has agreed to an FDA request to temporarily cease manufacturing at its Baltimore, Md.-based Bayview site, a pause that will last at least until the agency’s ongoing inspection concludes and remediation action is taken to clear the way for production of the Johnson & Johnson (J&J) vaccine. Read More