Recon: Novo restarts shipments of 1.7 mg dose of Wegovy in US; FDA approves Merck’s Keytruda combo for expanded cervical cancer use

• 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• PhRMA, Eli Lilly, other drug companies push back on FDA's draft guidance about communicating off-label use (Endpoints)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)