Archive for August 2018

A New York couple filed a class-action lawsuit against a distributor and two dispensers of valsartan products, claiming they were exposed to carcinogenic materials. Source: Drug Industry Daily

A federal court in Delaware Monday refused to undo a 2017 decision awarding $70 million to Amgen in its patent infringement battle with Hospira. Source: Drug Industry Daily

Illinois consumers covered under the Affordable Care Act will have access to expanded coverage for opioid addiction in 2020. The move comes after the Centers for Medicare and Medicaid Services Monday approved the state’s request to add the new benefits. Source: Drug Industry Daily

The FDA cited ADMA Biologics for failure to implement proper document controls and prevent unauthorized changes to data in its computer systems. Source: Drug Industry Daily

The U.S. Court of Appeals for the Federal Circuit Friday denied a request by generic drugmakers for a rehearing to challenge an epilepsy drug patent’s validity. Source: Drug Industry Daily

FDA draft guidance on assessing a new drug’s impact on blood pressure does not adequately explain the agency’s thinking on the use of smaller clinical trials and should incorporate a more risk-based approach, according to comments from three leading drug sponsors. Source: Drug Industry Daily

The FDA is proposing to exclude three substances from its 503B Bulks List of substances for outsourcing facilities to use in compounding drugs — including one that’s the subject of an Endo lawsuit against the agency. Source: Drug Industry Daily

The Senate passed an amendment Thursday to require drugmakers to list prescription drug prices in direct-to-consumer ads in an effort to promote lower prices through increased transparency. Source: Drug Industry Daily

The FDA rapped finished drugmaker Higiene + Salud for shoddy recordkeeping and deficient investigations after a November inspection of the company’s Toluca, Mexico facility. Source: Drug Industry Daily

A federal appeals court affirmed last week that Novartis did not engage in antitrust violations to protect a patent on its leukemia drug Gleevec (imatinib). Source: Drug Industry Daily