Five Prime Therapeutics Inc., in collaboration Zai Lab Limited on the development of bemarituzumab – a novel therapy for front-line advanced non HER2+ gastric or gastroesophageal junction (GEJ) cancer – announced groundbreaking positive topline Phase II results.
AstraZeneca and Daiichi Sankyo’s Enhertu received supplemental Biologics License Application (sBLA) acceptance and U.S. priority review for the treatment of HER2-positive metastatic gastric cancer.
Bristol Myers Squibb announced positive data from two separate Phase III clinical trials of the company’s checkpoint inhibitor Opdivo (nivolumab).
AstraZeneca and Daiichi Sankyo’s Enhertu helped patients with three different types of cancer live longer in trials, pointing to potential broader use of the breast cancer treatment.
Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.
AstraZeneca announced that the company’s Brilinta (ticagrelor) hit the primary endpoint in the Phase III THALES trial in stroke.
Daiichi Sankyo is taking Seattle Genetics to court over the technology the two companies used to develop antibody-drug conjugates (ADCs) during a partnership that spanned seven years.
Oncologie Inc. announced a clinical collaboration agreement with Merck to evaluate the combination of Oncologie’s investigational drug Bavituximab – an antibody that blocks the activity of phosphatidylserine – and Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with advanced gastric or gastroesophageal cancer.
Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
Amgen Inc. and Allergan plc announced that the U.S. FDA approved Kanjinti (trastuzumab-anns) for all approved cancer indications of the reference product Herceptin.