Recon: FDA approves Novo’s Wegovy to lower cardiovascular risks; Acadia’s schizophrenia drug misses primary goal in Phase 3 trial

• Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label (STAT) (Reuters)
• US FDA declines to approve Viatris's injection for multiple sclerosis (Reuters) (Endpoints)
• US FDA delays Lilly Alzheimer's drug decision, calls for advisory panel (Reuters)
• Amylyx's approved ALS drug flunks crucial test, shares dive (Reuters)
• Why Covid Patients Who Could Most Benefit From Paxlovid Still Aren’t Getting It (KFF)
• FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health (FDA)

• Serum Institute of India looks beyond COVID with new vaccines for malaria, dengue (Reuters)
• China to increase number of response teams for new infectious diseases (Reuters)
• Novo Nordisk tackles harm from Ozempic fakes with global authorities (Reuters)
• U.K. researchers warn about biases in medical devices, health care algorithms (STAT)
• CSL Praises Austria’s ‘Pioneering Funding Solution’ For Gene Therapy Hemgenix (Pink Sheet)
• New UAE Drug Agency Calls On Companies To Help Shape Mandate (Pink Sheet)
• First ‘Critical Medicines’ To Undergo EU Vulnerability Assessment (Pink Sheet)

• Biotech stock fundings headed for best quarter in 3 years, Jefferies says (BioPharmaDive)
• Acadia Pharmaceuticals' schizophrenia drug fails in late-stage study (Reuters)
• Fortrea sells enabling services and patient access businesses for up to $345 mln (Reuters)
• Cancer patients 'at risk' due to treatment delays, doctors say (BBC)
• Startups raised millions to in-license drugs to China. Then the model fell apart (Endpoints)
• Lilly's lebrikizumab, delayed at FDA, clears eczema in people with skin of color (Fierce)
• Boehringer boosts schizophrenia strategy with €25M upfront for option on Sosei’s GPR52 agonists (Fierce)
• Lexicon gears up for another shot in diabetes as path forward agreed with FDA (Endpoint)
• Novartis' BTK inhibitor beats placebo in dermatology trial, lining up another potential indication (Fierce)
• US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks (Pink Sheet)
• Sensorion's hearing loss drug reaches target in comeback story after phase 2 failure (Fierce)
• BioVie cuts ‘most de-risked program,’ will seek partners for phase-3 ready ascites program (Fierce)
• Incyte's JAK cream Opzelura proves its worth in treating hidradenitis suppurativa in midstage study (Fierce)

• FDA hands Class I label to Medtronic cerebrospinal fluid tubing recall (Fierce)
• FDA panel backs Lumicell’s agent for breast cancer imaging tool (MedtechDive)
• Advamed report finds racial disparities in care, proposes fixes (MedtechDive)

• Judge trims US Justice Department lawsuit against Walmart over opioids (Reuters)
• US Senate Advances BIOSECURE Legislation As China Biotech Security Heats Up (Pink Sheet)
• US officials urge UnitedHealth to expedite payments to providers (Reuters)
• Bluebird bio inks first Medicaid coverage agreement for sickle cell gene therapy, signing on with Michigan (Fierce)
• BeiGene files patent suits against Sandoz, MSN Group (Endpoints)
• Pfizer Defeats French Org's Bid For Vax Docs At 2nd Circ. (Law360)