Disease or Syndrome
Amgen’s Repatha Cholesterol-Lowering Shot Poised for Sales Boost After Landmark CV Prevention Trial Success
Amgen; Repatha; cholesterol-lowering; PCSK9 inhibitor; cardiovascular trial; VESALIUS-CV; primary prevention; heart disease; sales; LDL cholesterol
Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress
Vanda Pharmaceuticals; FDA; Hetlioz; jet lag disorder; tradipitant; lawsuit dismissal; collaborative framework; clinical trial hold; drug approval; sNDA; motion sickness
Behind-the-Scenes Details of 89bio’s $2.4B Deal with Roche
Roche; 89bio; pegozafermin; MASH; liver disease; contingent value rights; biotech acquisition; pharmaceuticals; deal structure; milestone payments
Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease
Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback
FDA Rejects CUTX-101 for Rare Copper Deficiency Due to Manufacturing Issues
FDA rejection; Menkes disease; CUTX-101; copper deficiency; manufacturing deficiencies; Cyprium Therapeutics; Sentynl Therapeutics; Fortress Biotech
Novartis Receives FDA Approval for Rhapsido: First Oral BTK Inhibitor for Chronic Hives
Novartis; Rhapsido; FDA approval; Bruton’s tyrosine kinase inhibitor (BTKi); remibrutinib; chronic spontaneous urticaria (CSU); chronic hives; immunology; oral therapy; competition
Novo Nordisk Terminates $598M Heart Failure Cell Therapy Collaboration with Heartseed Amid Major Restructuring
Novo Nordisk; Heartseed; heart failure; cell therapy; HS-001; collaboration termination; strategic restructuring; Maziar Mike Doustdar; diabetes; obesity; biotechnology
Star Therapeutics Raises $125M as Bleeding Disorder Therapy Enters Phase III
Star Therapeutics; Series D financing; bleeding disorders; VGA039; Phase III clinical trial; biotech funding; rare diseases; antibody therapy
Metsera’s New Obesity Data Raises Efficacy Profile, Key Side Effect Questions for Pfizer After Acquisition
Metsera; Pfizer; obesity drug; MET-097i; GLP-1; side effects; efficacy; Phase 2 trial; weight loss; Pfizer acquisition
Barinthus Biotherapeutics Announces Reverse Merger with Clywedog Therapeutics to Form New Metabolic Disease-Focused Company
Barinthus Biotherapeutics; Reverse Merger; Clywedog Therapeutics; Metabolic Diseases; Autoimmune Diseases; Topco; Shareholder Ownership Structure; UK Scheme of Arrangement; Delaware Merger; Self-Tender Offer; Lock-Up Period; Board Composition