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Par Pharmaceuticals has sued the FDA for not granting the company 180 days of marketing exclusivity for its first generic of Takeda Pharmaceutical’s Colcrys, asking a federal court to enjoin the agency from approving any competing generics. Read More
Repatha demonstrated positive effects on plaque buildup in coronary artery disease in patients already treated with optimized statin therapy. 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 maintain a monopoly on the market. Read More
The EMA is appealing a temporary injunction from the General Court of the European Union that prevents the agency from releasing a clinical study report on PTC Therapeutics’ Duchenne muscular dystrophy drug Translarna. Read More
British drugmaker GlaxoSmithKline will pay $20 million to settle the Security and Exchange Commission’s charges that the company bribed healthcare professionals to boost drug sales in China. Read More
The Department of Justice indicted two executives from separate pharmaceutical companies, alleging that one engaged in a kickback scheme and the other relied on confidential study findings to purchase and sell stock. Read More