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AstraZeneca is suing the FDA in an exclusivity dispute over its anti-cholesterol drug Crestor, claiming that the agency’s interpretation of the FD&C Act unfairly subjects the drug to early generic competition. Read More
The FDA made strides in its quality metrics endeavors Friday, complementing a draft guidance for submitting quality metrics data with a host of technical recommendations. Read More
BioMarin is calling it quits for its Duchenne muscular dystrophy candidate and three related products in its pipeline after the EMA’s Committee for Medicinal Products for Human Use signaled that it would not back the candidate. Read More
In response to industry concerns about the FDA’s handling of biosimilar applications, the agency is looking to establish a dedicated biosimilar review unit as part of BsUFA reauthorizations. Read More