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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
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
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
In an unusual move for a pharma company, New Jersey-based Pacira Biosciences has filed a libel lawsuit against the American Society of Anesthesiologists over several articles published in the society’s medical journal, charging the organization with unfairly disparaging its nonopioid painkiller Exparel. Read More