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A joint FDA advisory committee has cleared the way for Otsuka and Lundbeck’s Rexulti (brexpiprazole) as a new treatment for dementia-related agitation. Read More
The FDA’s Office of Regulatory Affairs (ORA) needs technological advances to create “one source of truth” rather than the siloed data systems that currently hamper its efforts to modernize inspectional work, according to its chief. Read More
Over the past week, the FDA issued two final and three draft guidances, as well as requests for comments on several advisory committee meetings, user fees, IND applications and the agency’s data and technology strategic plan. In addition, CDRH released details of the center’s Radiation Sterilization Master File Pilot Program. Read More
CDER’s Office of New Drugs (OND) Director Peter Stein is a nationally recognized leader in pharmaceutical research and development. Before joining the FDA in 2016 as OND deputy director he was a vice president at Merck Research Laboratories and formerly a vice president at Janssen. Read More
The White House said Thursday that it will ask the U.S. Supreme Court to step in to defend the FDA’s 22-year-old decision to approve the abortion drug mifepristone after an appeals court denied the Justice Department’s request to allow full access to the drug on Wednesday. Read More
Bristol Myers Squibb (BMS) and Pfizer have together filed separate lawsuits against two generic drugmakers, seeking to prevent the release of generic versions of Eliquis (apixaban), the blockbuster anticoagulant the pharma giants jointly developed. Read More
Bluebird Bio’s lovotibeglogene autotemcel (lovo-cel) and Vertex Pharmaceuticals’ exagamglogene autotemcel (exa-cel) gene therapies for severe sickle cell disease (SCD) would probably be cost-effective if priced around $2 million, according to a draft review by the Institute for Clinical Evaluation and Research (ICER). Read More
The FDA offers several pathways to expedite approval of new drugs to help get them to market much more quickly while still evaluating their safety. Read More
Arbutus Biopharma — which has been going after makers of the two messenger RNA (mRNA)-based COVID-19 vaccine makers alleging patent infringement — suffered a loss this week when a U.S. appeals court affirmed a decision to cancel its patent related to Moderna’s vaccine. Read More