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.
FDA Rejects Merck’s 6-Week Dosing Schedule for Keytruda
Blockbusters, Checkpoint Inhibitors, Classical Hodgkin Lymphoma, Complete Response Letter, Dosing, FDA, FDA/Regulatory, Gastric Cancer, Hepatocellular Carcinoma, Melanoma, Merkel cell carcinoma, Primary Mediastinal B-Cell Lymphoma (PMBCL), Supplemental Biologics License Application (sBLA)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.
Top 200 Medicines Annual Report 2019: The king of medicines
Ankylosing Spondylitits, August 2019, Autoimmune Diseases, Biologics, Biosimilars, Blockbusters, Cervical Cancer, Classical Hodgkin Lymphoma, Crohn's Disease, Esophageal Cancer, Forecasts, Gastric Cancer, Head & Neck Cancer, Hepatocellular Carcinoma, Hidradenitis suppurativa, Issue Archives, Juvenile Idiopathic Arthritis, Market exclusivity, Melanoma, Merkel cell carcinoma, Metastatic Urothelial Carcinoma (mUC), Microsatellite instability-high (MSI-H) cancer, Monoclonal Antibodies, Non-Small Cell Lung Cancer (NSCLC), Plaque Psoriasis, Primary lediastinal large B-cell lymphoma, Product Launches, Psoriatic Arthritis, Renal Cell Carcinoma (RCC), Rheumatoid Arthritis, Therapeutics, Top 200 Medicines, Ulcerative Colitis, UveitisHumira’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’s Keytruda Cuts Death Risk by 31 Percent in Esophageal Cancer
Blockbusters, Chemotherapy, Clinical Trials, Esophageal Cancer, FDA/Regulatory, Gastric Cancer, Gastrointestinal cancer, Hepatocellular Carcinoma, J.P. Morgan Healthcare Conference, PD-1 Inhibitors, R&D, Squamous Cell Carcinoma, TherapeuticsMerck & 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.
Investing Into R&D Pays off for Some of Biotech’s Biggest Companies
Acute Myeloid Leukemia (AML), Atrial Fibrillation, Big Pharma, Biotech, Blood Cancers, Cancer, Chemotherapy, Clinical Trials, Ebola Virus, Esophageal Cancer, FDA, Hepatocellular Carcinoma, Immunohistochemistry (IHC) Test, Infantile fibrosarcoma, Juvenile breast cancer, R&D, Tropomyosin Receptor Kinase (TRK) proteinsPwC’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.