WHO Approves First Prequalified Tuberculosis Diagnostic Test
The World Health Organization (WHO) has granted prequalification to the Xpert® MTB/RIF Ultra molecular diagnostic test, making it the first tuberculosis (TB) diagnostic and antibiotic susceptibility test to meet WHO’s…
Teva Reports Positive Phase 3 Results for AJOVY in Preventing Migraines in Youth
Teva Pharmaceutical Industries has announced encouraging results from its Phase 3 SPACE study, which evaluated the efficacy and safety of AJOVY (fremanezumab) for preventing episodic migraines in children and adolescents…
Novo Nordisk to Present New Data on Sickle Cell Disease and Hemophilia at ASH 2024
Novo Nordisk has announced that 13 abstracts from its research will be presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH) in San Diego,…
CVS Health Appoints New Leaders in Pharmacy and Consumer Wellness Divisions
CVS Health has announced two key leadership appointments to further strengthen its Pharmacy and Consumer Wellness division. Len Shankman has been appointed as president of Pharmacy and Consumer Wellness (PCW),…
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…