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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 engaged in deceptive marketing. Read More
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. Read More
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. Read More
Spending on prescription drugs sold through retail pharmacies in 2015 were estimated to comprise nearly 12 percent of total personal health care services spending in the United States. Read More
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. Read More
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 and severe pain. Read More