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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
FDA Delays NDA Decision on Heron’s Chemo Treatment
Nivalis Therapeutics Garners Orphan Drug Status for N91115
ALK’s Asthma Prevention Therapy Whiffs on Primary Endpoint
Loxo Oncology Wins EMA Orphan Drug Designation for LOXO-101
Ohio Citizen Drug Price Initiative Moves to Federal Court 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
Tweaking even one part of a clinical trial’s protocol — which happens more than half of the time in global trials — takes a toll on research, according to an analysis from the Tufts Center for the Study of Drug Development. Read More
Patent cases involving payments to delay generic competition have dropped 27 percent following a 2013 challenge to the practice, according to the Federal Trade Commission. Read More
Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for following the law. Read More
While the FDA is speeding many drugs to the market, the agency lacks reliable, accessible data needed to conduct systematic oversight and meet postmarket safety reporting responsibilities, says a GAO report released Thursday. 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