Novartis Pays $30M Upfront to Leqembi Creator BioArctic for Access to Blood-Brain Barrier Technology

Novartis; BioArctic; BrainTransporter platform; blood-brain barrier; neurodegeneration; Leqembi; partnership; antibody; milestone payments; royalties

Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder

Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials

Response Pharma: RDX-002 Limits Weight Regain After GLP-1 Therapy – Positive Phase II Results Announced

Response Pharmaceuticals; RDX-002; GLP-1 discontinuation; weight regain; obesity; Phase II clinical trial; postprandial triglycerides; cardiometabolic health; iMTP inhibitor

Insmed’s Brinsupri Receives First-Ever FDA Approval for Progressive Lung Disease

Brinsupri; Insmed; FDA approval; non-cystic fibrosis bronchiectasis; bronchiectasis; DPP1 inhibitor; brensocatib; progressive lung disease; neutrophil-mediated disease; first-in-class