We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Regeneron’s successful Biologics License Application (BLA) for its Ebola treatment Inmazeb last October was an example of the FDA’s new integrated-review process in action, an agency official said yesterday at the Drug Information Association’s annual meeting. Read More
The EMA, which plans to expand its preferred list to include 10 treatments, released the list for use by regulatory authorities in EU member states. Read More
The FDA is increasingly using patient experience data when approving new drugs or biologics, but the agency’s use of the data “varies widely,” an agency-commissioned report concluded. Read More
The FDA’s three-year-old pilot program on model-informed drug development (MIDD) has attracted more demand from industry than it can accommodate, an agency official said yesterday. Read More
Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium and sodium oxybates) has earned the FDA’s coveted seven-year orphan drug exclusivity for treating cataplexy or excessive daytime sleepiness in narcolepsy patients age seven years and up. The exclusivity is a big win for the company, which already has a narcolepsy cash cow on the market. Read More
The Institute for Clinical and Economic Review (ICER) has revised upward what it thinks Biogen’s controversial Alzheimer’s disease treatment Aduhelm (aducanumab) ought to cost, but the new estimate is still only a fraction of the $56,000 a year the company proposes to charge. Read More
HHS previously halted U.S. deliveries of bamlanivimab in late March because the antibody wasn’t effective against certain coronavirus variants. Read More
The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal antibodies and Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib). Read More
The FDA is prioritizing preapproval inspections of generics based on whether the products can alleviate drug shortages, agency officials said at the Drug Information Association (DIA)’s 2021 global annual meeting yesterday. Read More
Real-world medical evidence is increasingly taking its place alongside clinical trial data in decision-making by prescription drug sponsors and the FDA, said participants in a panel discussion yesterday at the Drug Information Association’s 2021 global annual meeting. Read More