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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
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