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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
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
The Biden administration announced Friday that it is dedicating $1.7 billion in funding from the COVID-19 relief package to ramp up U.S. capabilities for genomic sequencing, an effort to improve the ability of the Centers for Disease Control and Prevention (CDC) and the nation’s health departments to detect potentially deadly mutations. Read More
A potential new treatment for a severe form of Type 1 diabetes received a boost Thursday when the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted 12-4, with one abstention, that the benefits of the therapy outweigh its risks. Read More
The House has sent a pair of bipartisan bills aimed at lowering drug costs to the Oval Office for signature, including one that looks to improve the competitiveness of generics by tightening FDA exclusivities granted for drugs. Read More
A Centers for Disease Control and Prevention (CDC) expert advisory panel failed to vote yesterday or make any recommendation on Johnson & Johnson (J&J)’s suspended COVID-19 vaccine, opting to punt the issue until the committee reconvenes in approximately a week. Read More
In-person inspections of drug manufacturing plants by the FDA have been replaced by “remote interactive evaluations” only for the duration of the COVID-19 pandemic, the agency said in a new guidance released yesterday. Read More