Drug Industry Daily
Nov. 1, 2012
| Vol.
11 No.
215
| Full Issue in PDF Format
View the entire issue.
Ameridose is recalling all of its unexpired product as an ongoing FDA inspection of its Westborough, Mass., facility has raised sterility concerns.
Impax Laboratories’ reliance on a few key products — two generics and one brand drug — for the bulk of its revenue is likely to hurt the company in the near future as it loses its near monopoly on the drugs.
Biogen Idec’s positive Phase III results for its hemophilia A clotting factor candidate are pushing the company toward a U.S. filing in the first half of 2013.
The European Commission has approved Roche’s Avastin in combination with chemotherapy as a treatment for women with first recurrence of platinum-sensitive ovarian cancer.
The FDA has handed a warning letter to the Memorial Hospital of South Bend institutional review board (IRB) for failing to adequately protect child participants in clinical trials.
BioCryst Pharmaceuticals has decided to pull its IND for a new hepatitis C (HCV) drug after the FDA raised concerns about the drug’s toxicity profile.
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