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China cleared the way for the FDA to add 10 new drug investigators to its local roster, following a Dec. 4 meeting between U.S. Vice President Joe Biden and Chinese President Xi Jinping. Read More
Alexion’s recall and replacement of vials of its rare disease drug Soliris could cost the company between $10 and $25 million in the fourth quarter, the drugmaker says in a recent SEC filing. Read More
Sloppy investigations into various deviations such as hair in finished drug vials are outlined by the FDA in a Form 483 for OSO Biopharmaceuticals Manufacturing. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
A group of pharmaceutical representatives has recommended ten product and site quality metrics that the FDA should consider collecting from manufacturers, helping the agency shape its new quality metrics program. Read More
Alimera Sciences’ negotiations with the FDA on Iluvien have put the diabetic macular edema drug on a glide path to potential approval — a startling about-face following three complete response letters (CRL) for the drug’s application. Read More
Gilead Sciences’ drug Sovaldi appears primed to dominate the hepatitis C market with the release of new Phase III trial data showing subjects with genotype 1 of the virus benefit from the drug, without coupling it with interferon. Read More
The FDA has denied Éclat Pharmaceuticals’ unorthodox request for the agency to shut down competitors the company says are making unapproved versions of its medicine. Read More
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
In a new enforcement initiative intended to boost drugmaker quality, the European Medicines Agency (EMA) has begun publishing the names of manufacturing facilities that fall out of compliance with good manufacturing practices (GMP). Read More
The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More
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