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.
With BioMarin’s Duchenne muscular dystrophy candidate drisapersen failing to garner FDA approval this week, a competitor close on its heels also is facing questions from the agency over whether it offers any benefit. Read More
A clinical trial in France has left six hospitalized with one brain-dead in a “serious accident” that is triggering an inspection and investigation. Read More
The U.S. Patent and Trademark Office dealt Amgen a blow in its bid to market a biosimilar version of AbbVie’s Humira, refusing to block existing patents for the blockbuster rheumatoid arthritis treatment. Read More
In an effort to stay ahead of the threat of evolving superbugs, the National Institutes of Health announced it will fund novel antibiotic research to either complement or replace existing drugs. Read More
Prizing collaboration and reduced burdens on drugmakers, the European Medicines Agency hopes to bolster a stronger drug development process in the coming years. Read More
The Biotechnology Innovation Organization and a Duchenne patient advocacy group are joining forces to help drugmakers design clinical studies with patient input and drive rare-disease research. Read More
The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded. Read More
The FDA has delayed BioMarin’s plans to market drisapersen, the company’s Duchenne muscular dystrophy candidate, with a complete response letter calling for more evidence of the therapy’s benefits. Read More
Following the 2014 Ebola outbreak, the FDA is weighing the best options for testing and rapidly deploying treatments for emerging infectious diseases and wants to hear from you on the subject. Read More