Recon: FDA approves Axsome’s depression drug Auvelity after year-long wait; Gilead scores first global approval for HIV treatment
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA approves Axsome’s fast-acting treatment for major depression (STAT) (Endpoints) (Reuters)
- Bayer gets FDA nod to extend use of popular contraceptive IUD Mirena (Endpoints)
- FDA says Pharvaris’ HAE med is far from perfect, slaps on clinical hold (Fierce)
- Trick, or treat? FDA plans Halloween adcomm for Ipsen’s second chance at rare disease drug (Endpoints)
- FDA asks Pfizer to test second Paxlovid course in patients with COVID rebound (Reuters) (Bloomberg)
- Fauci to Step Down in December After Over 50 Years in Government (Bloomberg) (STAT)
- ICER panel says two ALS drug candidates have 'low' long-term value (Endpoints)
- FDA says it’s making recruitment strides, but problems with overseas inspections persist (Fierce)
- Major Indian generic drugmaker closes a U.S. facility after years of manufacturing problems (STAT)
- Pharma manufacturers in India, US latest to receive quality control hits from the FDA (Endpoints) (STAT)
- US NIH Testing Strategy To Stretch Monkeypox Vaccine Supply Even Further (The Pink Sheet)
- ‘I’m Still Here’: Janet Woodcock’s Swan Song At US FDA Looking Like A Longer-Term Job (The Pink Sheet)
- U.S. clinics scramble as courts, politicians battle over abortion restrictions (Reuters)
- After FDA rejection, Gilead’s long-acting HIV med Sunlenca snags first global nod (Fierce) (Biospace) (Endpoints)
- Monkeypox vaccines to be piloted in smaller but equally effective doses (UK Health Security Agency)
- Cost Of Providing CAR-T Therapies Could Derail Reimbursement In England (The Pink Sheet)
- Moderna to supply 12 million doses of Omicron-targeted COVID shot to Canada (Reuters)
- New Global Venture Offers Free Access To Promising Antimalarial Compounds (The Pink Sheet)
- WHO recommends use of two antibody drugs against Ebola (Reuters)
- New Ebola case confirmed in eastern Congo, linked to previous outbreak (Reuters)
- Teva charts 300-plus layoffs at troubled California plant (Fierce)
- Fierce Biotech Layoff Tracker: Clarus cuts 40% staff, Vedanta reveals workforce reduction (Fierce)
- Fresenius SE CEO to quit after earnings outlook sours (Reuters)
- Backed by Medicxi, Novartis vets launch rare blood disorder biotech with fresh take on drug class used in cancers (Endpoints)
- With Duchenne Filing Due, Santhera Moves Vamorolone Into Becker Muscular Dystrophy (Scrip)
- 2 biotechs swoop into monkeypox scene with new R&D licensing pact (Fierce)
- Elon Musk reportedly approached Neuralink competitor Synchron about potential deal: Reuters (Fierce)
- Eisai inaugurates new US HQ as closely watched Alzheimer’s decision draws near (Fierce)
- The top 10 global R&D institutes of 2021 (Fierce)
- Covid Incubation Gets Shorter With Each New Variant, Study Shows (Bloomberg)
- Insulet’s Omnipod 5 insulin pump scores FDA nod for toddlers with Type 1 diabetes (Fierce)
- Morcellation Use Drops After FDA Warning (MedTech Insight)
- US FDA Adds More MDRs To Philips Recall, Including Deaths (MedTech Insight)
- Medtronic gets third Class I label in 2022 for latest HVAD recall (MedTech Dive)
- Italy Boosts Per Capita Spend On Medtech, But Key Questions Hang Over Needs (MedTech Insight)
- Edwards gets CE mark for Pascal Precision system, allowing device to be marketed in Europe (MedTech Dive)
- Accessing Unapproved Medical Devices – Comparing The Singapore And US Experiences (MedTech Insight)
- Medical device recalls hit two-year high in Q2, report finds (MedTech Dive)
- Friday Q&A: ResMed CEO Mick Farrell discusses Philips recall, improving supply chain, prioritizing patients (MedTech Dive)
- GSK to SCOTUS: Don't take up 'skinny' generic drug label case (Endpoints)
- Endo loses Vasostrict patent battle as sales take a hit from generics (Endpoints)
- Vifor, Fresenius Win Long-Waited Ruling on Teva’s Velphoro Copy (Bloomberg)
- Elizabeth Holmes’s Victims Asked to Weigh in for Sentencing (Bloomberg)
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