FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan for EGFR+ NSCLC
Merck known as MSD outside the U.S. and Canada, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment…
Roche Forms Partnership with COUR in Autoimmune Disease Deal Worth Over $900M
COUR Pharmaceuticals, a biotech company based in Chicago, has entered into a significant partnership with Roche’s Genentech to develop and commercialize treatments for an undisclosed autoimmune disease. This collaboration follows…
Intra-Cellular Seeks Depression Approval for Caplyta as Stock Remains Under the Radar
Intra-Cellular Therapies has submitted a supplemental New Drug Application (sNDA) to the FDA for its drug Caplyta (lumateperone) for the treatment of Major Depressive Disorder (MDD) in adults. The approval…
Ipsen & Biomunex Sign Global Deal for MAIT Cell Engager in Immuno-Oncology
Ipsen and Biomunex Pharmaceuticals have entered into an exclusive global licensing agreement for BMX-502, a promising bispecific antibody designed to target and activate Mucosal-Associated Invariant T cells (MAIT cells) to…
Intra-Cellular Therapies Files sNDA for CAPLYTA® as Adjunctive MDD Treatment
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company dedicated to central nervous system (CNS) therapeutics, has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food…
Report from the 40th Polio IHR Emergency Committee Meeting
The World Health Organization (WHO) convened the 40th meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on November 6, 2024. The committee, composed of members, advisers,…
Ono and Congruence Partner on Oncology Drug Discovery
Ono Pharmaceutical Co., Ltd. (Ono), headquartered in Osaka, Japan, has entered into a strategic collaboration agreement with Congruence Therapeutics, a biotechnology company based in Montreal, Canada. This partnership aims to…
Revolution Medicines Prices $750M Public Offering
Revolution Medicines a clinical-stage oncology company focused on developing therapies for RAS-addicted cancers, has announced the pricing of its upsized public offering. The offering consists of 14,130,436 shares of common…
Daiichi Sankyo Showcases Oncology Progress at ESMO Asia, SABCS, and ASH
Daiichi Sankyo will present over 45 abstracts highlighting the progress across its oncology portfolio at the 2024 ESMO Asia Congress,San Antonio Breast Cancer Symposium and The American Society of Hematology…
New Biovanta Study Demonstrates Highest Efficacy in Treating Common Cold
Common cold viruses cause substantial productivity losses and negatively impact overall well-being, with an estimated $40 billion lost annually in the United States alone. However, a new study published in…
Melinta Joins NHIA’s Future of Infusion Advisory Council
The National Home Infusion Association (NHIA) and Melinta Therapeutics, LLC, a biopharmaceutical company specializing in innovative therapies for acute and life-threatening conditions, are excited to announce Melinta’s membership in NHIA’s…
Revolution Medicines Shares Clinical Updates on RAS(ON) Inhibitor Portfolio
Revolution Medicines a clinical-stage oncology company developing targeted therapies for RAS-driven cancers, announced significant clinical updates from its RAS(ON) inhibitor portfolio. The data, presented during an investor webcast, focused on…