In a citizen petition filed Monday, Pfizer asked the FDA to issue draft guidance to prevent misleading communications by reference drug sponsors on the effectiveness of biosimilars. Source: Drug Industry…

Compounding pharmacy Kelley-Ross & Associates in Seattle drew a warning letter from the FDA after an agency inspection in July found numerous sanitation violations. Source: Drug Industry Daily

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…

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FDA draft guidance on assessing a new drug’s impact on blood pressure does not adequately explain the agency’s thinking on the use of smaller clinical trials and should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…

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…

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…