The U.S. FDA approved Acorda Therapeutics’ Inbrija, the first inhaled formula of levodopa (L-dopa) for the intermittent treatment of OFF episodes in Parkinson’s disease patients.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
The U.S. Food and Drug Administration approved Stemline Therapeutics Inc.’s Elzonris for the treatment of a rare blood disease in adults and children aged 2 years and older.
The U.S. Food and Drug Administration approved Alexion Pharmaceuticals Inc.’s rare blood disorder drug Ultomiris, an early backing that also solidifies the company’s dominant market position.
Merck received FDA approval for new indications for the PARP inhibitor Lynparza – which is jointly developed and commercialized by AstraZeneca – and the checkpoint inhibitor Keytruda.
China became the first country to approve a new anemia drug from AstraZeneca and FibroGen, well before decisions by regulators in the United States or Europe.
Celltrion Inc. and Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab).
Roche Holding AG’s Tecentriq immunotherapy in combination with Avastin and chemotherapy won U.S. Food and Drug Administration approval as a first-line treatment for a type of lung cancer.
The U.S. Food and Drug Administration approved the first test – a diagnostic from Meridian Bioscience Inc. – to help detect a type of herpes virus in newborns.
The U.S. Food and Drug Administration green-lit a new treatment for acute myeloid leukemia (AML) for patients who have a rare and life-threatening disease mutation, developed by Astellas Pharma Inc.