Intellia Therapeutics Announces FDA Lifts Clinical Hold on MAGNITUDE-2 Phase 3 Trial for ATTRv-PN Intellia Therapeutics, Inc., a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has removed…
Will Forte Partners with Teva to Launch “Honestly HD”—A Candid Conversation About Huntington’s Disease Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced a partnership with actor, comedian and advocate, Will Forte, to…
Neurocrine Biosciences Launches Phase 2 Trial of NBI-1065890 for Tardive Dyskinesia in Adults Neurocrine Biosciences, Inc. today announced the initiation of its Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD). NBI-1065890 is a next-generation,…
BioMarin Moves to Strengthen BalanceBioMarin Announces Proposed Private Offering of Senior Notes and New Senior Secured Term Loan Syndication BioMarin Pharmaceutical Inc. announced today that it intends to offer, subject to market and other conditions, $850 million of senior unsecured…
Trelegy Ellipta Gains Approval in China for Adults with Uncontrolled Asthma GSK plc today announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of patients…
Aspect Biosystems and Novo Nordisk Advance Partnership to Develop Curative Diabetes Therapies Novo Nordisk and Aspect Biosystems today announced they are entering a new phase of their partnership to develop advanced cellular medicines for diabetes. Since 2023, Aspect andNovo Nordisk…
Lilly’s Sacituzumab Govitecan Receives U.S. FDA Breakthrough Therapy Designation for Platinum-Resistant Ovarian Cancer Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for the treatment of adult patients…
FDA Awards Orphan Drug Designation to BlueRock Therapeutics’ Investigational Cell Therapy OpCT-001 Bayer AG and its wholly owned, independently operated subsidiary BlueRock Therapeutics LP, a clinical stage cell therapy company, today announced that its investigational cell therapy, OpCT-001, has received…
Bristol Myers Squibb Teams Up with Microsoft to Accelerate AI-Powered Early Lung Cancer Detection Bristol Myers Squibb, a global leader in oncology, today announced an agreement with Microsoft, a market leader in AI-powered radiology and clinical workflow technologies, aiming to…
ENHERTU® Plus Pertuzumab Moves Closer to EU Approval as First-Line Therapy for HER2-Positive Metastatic Breast Cancer In a significant milestone for oncology innovation, the European Medicines Agency (EMA) has officially validated the Type II Variation marketing authorization application for ENHERTU®…
Shionogi Receives Minister of Health, Labour and Welfare Award for Cefiderocol at the 8th Japan Medical Research and Development Grand Prize Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereinafter, “Shionogi”) announced that it had…
Neurocrine Biosciences Presents Head-to-Head Data Showing INGREZZA® (valbenazine) Capsules Achieve Higher VMAT2 Target Occupancy Than AUSTEDO XR Neurocrine Biosciences, Inc. today announced the presentation of the first head-to-head data comparing vesicular monoamine transporter 2 (VMAT2) target occupancy between INGREZZA® (valbenazine) capsules and AUSTEDO XR…