Recon: Novo restarts shipments of 1.7 mg dose of Wegovy in US; FDA approves Merck’s Keytruda combo for expanded cervical cancer use
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- New congressional bill would thwart patent thickets in order to speed generic drugs to market (STAT)
- US FDA Resists Proposals For Mideast Presence To Boost Pharmaceutical Imports From Allies (Pink Sheet)
- Medicare Price Offers, Due Feb. 1, Will Be Informed By Therapeutic Alternatives; That’s A Tall Order (Pink Sheet)
- Four buyouts (and one rumor that didn’t materialize); Isomorphic Labs' first pharma deals; A CAR-T IPO; #JPM24 highlights; and more (Endpoints)
- PhRMA, Eli Lilly, other drug companies push back on FDA's draft guidance about communicating off-label use (Endpoints)
- Economists, health policy experts say J&J's IRA arguments are 'overly simplistic' (Endpoints)
- Novo Nordisk resumes shipments of Wegovy 1.7 mg dose in US (Reuters)
- Merck's Keytruda combo gets FDA nod for expanded use in cervical cancer (Reuters)
- Record budget for Gates Foundation as wider global health funding stalls (Reuters)
- WHO appeals for $1.5 bln to address crises from Gaza to Afghanistan (Reuters)
- January Is A Busy Month For Cross-Sectoral Health Partnerships Under The EU’s IHI (MedTech Dive)
- Is EU Medtech Regulatory Reform On The Horizon? Seven Expert Perspectives Entering 2024 (MedTech Dive)
- EU Regulators Told To ‘Normalize’ Decentralized Clinical Trials (Pink Sheet)
- EMA Recommends Precautions When Prescribing Valproate for Men (Pink Sheet)
- Boehringer Ingelheim pledges €120M to expand Greek plant, add capacity for Jardiance (Fierce Pharma)
- Trade union opposes possible split-up of Germany's Bayer (Reuters)
- For-profit biomedical institute, backed by billionaires, launches in Cambridge to speed drug discovery (STAT)
- CAR-T hype faces infrastructure reality check (Fierce Pharma)
- Lilly’s Direct-to-Consumer GLP-1 Service Likely Doesn’t Threaten PBMs (Pink Sheet)
- Novartis reportedly decides to pass on Cytokinetics (STAT)
- For-profit biomedical institute, backed by billionaires, launches in Cambridge to speed drug discovery (STAT)
- Mid-stage CNS biotech Alto Neuroscience files for NYSE listing (Endpoints)
- Exclusive: Autoimmune CAR-T biotech Kyverna Therapeutics is considering an IPO next month (Endpoints)
- BioMarin's chief commercial officer stepping down, search for successor begins (Endpoints)
- Evaluate buys forecasting group to build out prediction software and services (Endpoints)
- Artificial heart maker Carmat misses 2023 revenue target (Reuters)
- Resmed’s magnetized masks linked to 6 patient injuries, FDA says (MedTech Dive)
- Roundup: AI-Powered Assistive Hearing Devices Scream With Personalization; Femtech From Baby Makers To Menopause (MedTech Insight)
- News We’re Watching: V-Champs Winners Named, Recalls for Fresenius Infusion Pumps and GE Vents, FCC Updates Rural Telehealth Rule (MedTech Insight)
- JPM 2024: Intuitive And J&J Both Weigh In On Growth For 2024 (MedTech Insight)
- 'Blah-Blah' May Subside, But Harnessing AI Ethically, Impactfully Is Key For Medtech In 2024 (MedTech Insight)
- Nonprofit health systems plug their strong cash reserves at JPM — a very different pitch than they make elsewhere (STAT)
- Fiery MedPAC meeting highlights massive overpayments in Medicare Advantage (STAT)
- “Thaw Out” with Pharma Thought Leaders at the 2024 Puerto Rico Pharmaceutical Summit: HPM Directors to Discuss Drug Approvals and Puerto Rico “Exportation” Best Practices (FDA Law Blog)
- ESG In 2024: Stakeholder Views From ‘Strategic Imperative’ To ‘Largely A Nonsense’ (MedTech Insight)
- FDA’s LDT Proposal, AI Oversight, Cybersecurity Top US Regulatory Interests In 2024 (MedTech Dive)
- FDA Finds no Link Between GLP-1 Drugs and Suicidal Thoughts (BioSpace)
- Appeals court allows unique argument in Gilead's legal battle over HIV meds (Fierce Pharma)
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