In a complaint filed in the District Court of the Central District of California, Immunex asserts Sanofi and Regeneron infringed on the Immunex patent for Dupixent, which the FDA approved…

A federal judge has ruled that a class-action antitrust lawsuit against several generics manufacturers, alleging price-fixing of propranolol capsules and tablets, can proceed in court. Source: Drug Industry Daily

GlaxoSmithKline has asked the U.S. Supreme Court to rule on the proper jurisdiction for a suit over birth defects and its antidepressant Paxil. Source: Drug Industry Daily

The Maryland state legislature has approved a bill to ban excessive price increases for generics and off-patent drugs, and is sending it to the state’s governor for final approval. Source:…

PhRMA has endorsed the FDA’s plan to release more timely inspection information relevant to drug product reviews. Source: Drug Industry Daily

The PTO’s Patent Trial and Appeal Board upheld Shire’s patent claims — following a challenge from Green Cross — over methods for the manufacture of Elaprase (idursulfase), an enzyme replacement…

The FDA rejected Merck’s bid to add cardiovascular safety data to its oral diabetes medication Januvia and its combinations. Source: Drug Industry Daily

Less than a month shy of mandating electronic submissions of drug and biologic master files in the eCTD format, the FDA has decided to postpone the requirement until May 2018.…

The FDA cited drug manufacturer Aurobindo Pharma for inadequate computer access controls and written procedures. Source: Drug Industry Daily

The FDA received a fresh wave of ANDAs in March, nearly doubling the total amount from the first two months of the year. Source: Drug Industry Daily