Boehringer Ingelheim agreed to pay $13.5 million to all 50 states and the District of Columbia to settle a lawsuit alleging the company promoted unapproved uses of prescription drugs and…
The FDA removed its Boxed Warning regarding asthma-related death from the labels of medicines containing long-acting beta agonists in combination with inhaled corticosteroids, following postmarket studies of possible side effects.…
The FDA is revising its 20-year-old guidance on the appropriate categorization of changes in chemistry, manufacturing and controls information in approved BLAs, based on a tiered reporting system. Source: Drug…
The PTO’s Patent Trials and Appeals Board launched an inter partes review of two patents for Sanofi’s Lantus insulin glargine injection following a challenge from Mylan. Source: Drug Industry Daily
The French Competition Authority fined Johnson & Johnson €25 million ($27 million) for delaying market access to generic copies of its painkiller Durogesic, a fentanyl-based patch for treatment of chronic…
In a new policy initiative, the FDA outlined new enforcement measures for homeopathic products. Source: Drug Industry Daily
Retail prescription drug prices have nearly doubled since the 1990s according to a Government Accountability Office report issued Tuesday. Source: Drug Industry Daily
The House of Representatives moved closer to passing the final version of the Republicans’ tax reform legislation Tuesday, a sweeping $1.5 trillion measure that reduces or eliminates many deductions and…
Closing what it calls an “unintended loophole,” the FDA will no longer issue orphan drug designations for smaller pediatric subpopulations of more common diseases, unless certain criteria are met. Source:…
The FDA approved Spark Therapeutics’ novel gene therapy to treat an inherited form of vision loss — making it the first genetic therapy approved in the U.S. to target a…