The Food and Drug Administration regulates more than a third of the U.S. economy. And its new commissioner, Scott Gottlieb, is trying to shake up how it does so.
Merck’s Keytruda combo therapy succeeds in Phase-III lung cancer trial; FDA launches pilot to address trial transparency; Spark’s Luxturna overpriced, ICER says
BI to pay $13.5 million for misleading marketing; ICER: CAR-T therapies more cost-effective than chemotherapy; FDA approves Roche’s breast cancer combo therapy
Pharma industry spent $57 million on lobbying in 2016; Humana, private equity firms to buy Kindred for $4 billion; price of old glaucoma drug skyrockets
CVS/Aetna deal will affect healthcare benefits; lawmakers pressure DEA to curb painkiller supply; Allergan and Richter’s Vraylar sees positive results for bipolar depression
FDA approves first topical skin growth treatment; Teva to cut 14,000 jobs; Novartis Oncology CEO resigns
FDA issues prescription drug promotion guidance; FDA approves first follow-on biologic of Lilly’s Humalog; drugmakers allegedly hired nurses to promote drugs
FDA approves first nebulized LAMA COPD treatment; more than 2,000 cancer immunotherapies in development; FDA issues 3D-printing guidance