Recon: FDA approves Axsome’s depression drug Auvelity after year-long wait; Gilead scores first global approval for HIV treatment

Regulatory NewsRegulatory News | 22 August 2022 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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