Recon: FDA approves Novo’s Wegovy to lower cardiovascular risks; Acadia’s schizophrenia drug misses primary goal in Phase 3 trial
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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