Recon: US Patent Office to review Novo Nordisk semaglutide patent; WHO portal aims to simplify prequalification process
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Key Senate panel eyes action on drug shortages (STAT)
- Cancer drug shortage eases slightly, but it’s still ‘living from paycheck to paycheck’ (STAT)
- Was Amgen less than forthcoming about FDA’s concerns on its cancer drug? (STAT)
- Moderna’s plan to make a single vaccine for Covid, influenza, and RSV is on track (STAT)
- US Patent Office will review Novo Nordisk patent related to Wegovy, Ozempic (Reuters)
- US plans shift of Merck COVID treatment to commercial market (Reuters)
- 3 questions for the future of Biden’s cancer moonshot (STAT)
- FDA hands down partial clinical hold to Innate Pharma for cancer drug trials after patient death (Endpoints)
- FDA's oncology advisory committee backs potential high-risk neuroblastoma treatment (Endpoints)
In Focus: International
- Novo Nordisk's Wegovy bonanza looms large in Denmark (Reuters)
- New ePortal To Simplify Processing & Tracking Of WHO Prequalification Applications (MedTech Insight)
- Lonza expands antibody-drug conjugate production pact, plots 180 new hires (Fierce Pharma)
Pharma & Biotech
- Failed biotech gives a rare peek inside the tough breaks — and tough choices — that led to its demise (STAT)
- UniQure halves research, lays off 20% while CSO departs in major revamp (Endpoints)
- Gene therapy maker Orchard Therapeutics sells to Kyowa Kirin for $387M cash as lead program awaits 2024 FDA verdict (Endpoints)
- BMS-backed liquid biopsy biotech Precede Biosciences debuts to enhance precision medicine approaches (Endpoints)
- EQRx had limited buyer interest, tried acquiring other companies before Revolution came for its cash (Endpoints)
- With key Mounjaro decision ahead, Eli Lilly shuffles its C-Suite deck (Fierce Pharma)
- Public wants pharma to reveal carbon footprint of drugs (Pharmaphorum)
Medtech
- Why Andreessen Horowitz's Julie Yoo sees AI as a 'leapfrog opportunity' for healthcare (Endpoints)
- Health tech startup Atropos reveals generative AI tool for parsing patient records (Endpoints)
- Medtronic posts warning after stolen, defective intubation devices advertised for sale (MedTech Dive)
- Medtronic Hires New Neuromodulation Leader (MedTech Insight)
- Medtech Connect Episode 10: Breaking Down The Transitional Coverage Of Emerging Technologies (MedTech Insight)
- Minute Insight: Stimdia Starts Trial Of Phrenic Nerve Stimulator For Patients On Ventilators (MedTech Insight)
Government, Regulatory & Legal
- FDA cites Fresenius Kabi for contamination problems that CDC linked to deadly sepsis cases (STAT)
- Preliminary Injunction Decision in Chambers of Commerce Case Provides First Insights Into Merits of Medicare Negotiations Cases (FDA Law Blog)
- FDA calls for treatments for meth and cocaine addiction (STAT)
- Slew of pharma industry players form coalition to push back against antitrust reform (Endpoints)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
