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The FDA has released more meeting minutes from its talks with industry on reauthorization of the Prescription Drug User Fee Act (PDUFA), noting that there is interest in seeing the agency commit to expanding its use of real-world data in drug reviews, its capabilities for cell and gene therapy products, and other changes. Read More
The Government Accountability Office (GAO) released a new report yesterday warning the FDA about the state of its COVID-19-era inspections backlog, cautioning that the agency needs to develop alternative inspections tools and address its lack of foreign inspections as soon as possible. Read More
The FDA has laid out its plan to modernize the way it interacts with data to inform regulatory decisions like drug reviews, unveiling a three-component Data Modernization Action Plan (DMAP) on Wednesday that will begin bringing its data strategies up to date. Read More
Ovid Therapeutics is selling the global rights to an investigational drug for rare epileptic diseases to Takeda Pharmaceutical in a deal worth potentially $856 million — as Ovid shifts gears and focuses on research of new neurological therapies. Read More
AstraZeneca (AZ) has won a patent lawsuit in a federal court against Mylan Pharmaceuticals and Kindeva Drug Delivery, which were planning to make generic versions of AZ’s blockbuster asthma drug Symbicort (budesonide/formoterol). Read More
The FDA has issued a warning letter to HealthQuilt, the sponsor of a clinical trial evaluating a drug product as a COVID-19 treatment, citing its failure to submit an Investigational New Drug (IND) application for the product being studied, among other problems. Read More
Indian drugmaker Bharat Biotech has announced that its COVID-19 vaccine candidate, Covaxin (BBV152), proved to be 80.6 percent effective in the initial interim analysis of its late-stage clinical trials. Read More
Merck is planning to launch a new late-stage trial of an experimental COVID-19 treatment, MK-7110 (CD24Fc), because the previous phase 3 study enrolled too few participants to support regulatory clearance from the FDA. Read More