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The FDA has slapped India’s Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More
A federal appeals court has ruled that Caraco Pharmaceutical Laboratories’ assumption that its plants wouldn’t be closed for GMP violations was not legal justification for it to skirt layoff-notice labor laws. Read More
The UK’s National Institute for Health and Care Excellence delivered a stinging rebuke to Alexion Pharmaceuticals, saying it would not reimburse Kanuma for the treatment of lysosomal acid lipase deficiency until more evidence could support it. Read More
New FDA guidance is offering companies a way to test anti-clotting drugs for potentially fatal immune responses without the time or expense of additional clinical trials. Read More
Fresenius Medical Care will shell out $250 million to settle more than 400 lawsuits alleging harm from two of its drugs, GranuFlo and NaturaLyte, under a proposed settlement announced Wednesday. Read More
Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief before the U.S. Court of Appeals for the Federal Circuit. Read More