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The FDA has cited a Dr. Reddy’s manufacturing site for a slew of violations, including deficient air supply in aseptic processing areas and a lack of microbiological testing. Read More
The FDA issued a warning letter to an active pharmaceutical ingredient distributor in Chongqing southwestern China for serious problems with quality and certificates of analyses (COAs). Read More
Ohio Attorney General Dave Yost has asked the Sixth Circuit Court of Appeals to delay an upcoming trial of two bellwether cases brought by Cuyahoga and Summit counties against Purdue Pharma. Read More
The FDA hit API drugmaker Alps Pharmaceutical of Gifu, Japan with a Form 483 for contamination, inadequate written procedures for cleaning and other violations. Read More
In a win for Allergan, the U.S. Court of Appeals for the Federal Circuit upheld a federal court ruling blocking Sandoz’s proposed generic of Allergan’s eye drops Combigan (brimodine/timolol). Read More
The Patent Trial and Appeal Board (PTAB) said it’s opening an inter partes review (IPR) of patents covering Alexion Pharmaceuticals’ immunosuppressive drug Soliris (eculizumab), following a petition by Amgen. Read More
PhRMA said it “strongly encourages” the FDA’s new “integrated review process,” which combines assessments by the agency’s different disciplines into a single document for new drug applications and efficacy supplements. Read More