After touting positive Phase III results at the American Society of Hematology’s annual meeting, the U.S. FDA placed a clinical hold on uniQure”s hemophilia B treatment AMT-061 due to a patient developing liver cancer.
The U.S. Food and Drug Administration approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
The U.S. Food and Drug Administration reviewed several drugs under Priority Review ahead of their PDUFA target action dates scheduled during the week of March 8th, 2020.
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.
Cambridge, Mass.-based Dicerna Pharmaceuticals signed a research collaboration and licensing deal with Switzerland’s Roche for chronic hepatitis B virus therapies that could hit $1.67 billion.
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.
Merck & Co. released data from KEYNOTE-181, a Phase III trial of Keytruda as a monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma.
PwC’s annual R&D spending report showcases companies that stand out in the field of biotechnology.
Gilead Sciences and its cell therapy subsidiary Kite Pharma agreed to acquire Cell Design Labs.
Exelixis’s Cabometyx (cabozantinib) hit key endpoints of overall survival in its Phase III liver cancer trial.