Epizyme’s oral potent, first-in-class EZH2 inhibitor tazemetostat won accelerated approval from the U.S. Food and Drug Administration for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Ireland’s Horizon Therapeutics became the first to win regulatory approval in the United States for the treatment of Thyroid Eye Disease (TED), a progressive autoimmune disorder that can threaten the vision of those afflicted.
Novo Nordisk is involved in a clinical trial using the company’s GLP-1 analog diabetes drug Victoza to evaluate if the medicine can improve brain function and cognition in Alzheimer’s patients.
Eli Lilly’s senior vice president and chief financial officer Josh Smiley announced plans for the Indianapolis-based pharmaceutical company to spend from $1 billion to $5 billion each quarter during 2020 to bolster the drug manufacturer’s product pipeline.
Novo Nordisk’s Ozempic (semaglutide) won approval from the U.S. Food and Drug Administration to reduce the risk of major adverse cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.
The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) generated an evenly split vote on whether to recommend approval of Durect Corporation’s Posimir.
The software of life is how Moderna Inc. CEO Stephane Bancel describes messenger RNA (mRNA), which is at the core of the company’s drug development process.
Amarin Corporation plc announced the launch of True To Your Heart, an educational campaign to help people learn more about cardiovascular disease and how to better protect against persistent cardiovascular risk.
Gilead Sciences Inc. will access Xencor Inc.’s Xtend extended half-life and Cytotoxic XmAb Fc technologies for developing and commercializing GS-9722, Gilead’s first-in-class effector-enhanced broadly neutralizing anti-HIV antibody.
Pfizer and EMD Serono – the biopharmaceutical unit of Darmstadt, Germany-based Merck KGaA – announced that the companies’ Phase III JAVELIN Bladder 100 trial hits the primary endpoint of overall survival (OS) at a planned interim analysis.