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A nearly two-year antitrust investigation by the Justice Department that involves more than a dozen generics makers could result in price-collusion charges before the year ends, according to a source familiar with the matter. Read More
The UK Court of Appeal affirmed an earlier ruling that invalidated Pfizer’s patent claims for Lyrica and ruled generics would not lead to infringements. Read More
Industry groups have endorsed the FDA’s commitment goals for BsUFA II, asking Congress to reauthorize the user fee program intended to improve review efficiency. Read More
The FDA’s commitment goals for GDUFA II were backed by industry at a recent meeting, bringing the user fee program closer to reauthorization. Read More
A federal judge ruled that Apotex’s biosimilars of Amgen’s Neulasta and Neupogen do not infringe on a patent that covers a protein refolding process. Read More
A federal judge awarded Fresenius a preliminary injunction that blocks Fera Pharmaceuticals from marketing a levothyroxine sodium generic for the treatment of an underactive thyroid. Read More
A federal appellate court upheld a district court dismissal of Mylan’s antitrust case against Warner Chilcott and Mayne Pharmaceuticals, which alleged that the name-brand drugmakers modified their acne treatment Doryx to block generic competition and maintain a monopoly on the market. Read More
Alcon Pharmaceuticals is asking the FDA to apply stricter requirements on bioequivalence studies intended to supplement applications for Durezol and Ciprodex generics. Read More
The FDA doesn’t have explicit penalties for failing to self-identify as a generic facility, but noncompliance can raise the likelihood of a pre-approval inspection, the agency. Read More
A federal judge rescinded his own verdict backing the FDA’s decision to not grant Ferring exclusivity for its bowel preparation drug Preponik, ruling that the agency must give the company five-years of retroactive exclusivity. Read More