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The European Medicines Agency (EMA) has approved the scale-up of manufacturing of messenger RNA-based COVID-19 vaccines from Pfizer/BioNTech and Moderna to increase supply to the EU, which now appears to be strongly favoring mRNA vaccines over viral vector-based products from AstraZeneca and Johnson & Johnson. Read More
Hiring and retention of FDA talent needed for PDUFA VII reviews were a focus of several meetings of a PDUFA finance subgroup, according to recently posted FDA meeting summaries from January and February. Read More
Public Citizen says “the agency was aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit.” Read More
Speaker Nancy Pelosi (D-Calif.) announced the reintroduction of the House Democrats’ flagship drug pricing legislation, H.R. 3, on Thursday, signaling their intention to fight for its inclusion in President Biden’s next spending package. Read More
Public Citizen is urging the FDA to convene an expert panel to discuss rescinding approval for Gilead Sciences’ Veklury (remdesivir) as a COVID-19 treatment. Read More
In January, the UK launched an accelerated drug approval mechanism, the Innovative Licensing and Access Pathway that involves multiple government entities, including NICE. Read More
The FDA has granted Breakthrough Therapy designation for Amgen’s investigational antibody bemarituzumab as a first-line treatment for gastric cancer. Read More
In a move that clears the way for EU member states to resume inoculations with the Johnson & Johnson (J&J) vaccine, the European Medicines Agency (EMA) concluded yesterday that the vaccine’s labeling should include a warning about the risk of blood clots and the company said vaccine deliveries in Europe will resume. Read More
A group of healthcare attorneys and economics experts is rallying the FDA to offer lower user fees for smaller generics companies in the agency’s third iteration of the Generic Drug User Fee Act (GDUFA), arguing the move would encourage more companies to enter the generics market. Read More
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