Recon: Senators press FDA on device oversight after Philips recall; White House seeks to impose inflation penalties on drugmakers

• Why FDA product recalls have spiked in recent years (STAT)
• Is it time to worry about Moderna? (STAT)
• Benefits of Moderna and Merck melanoma vaccine plus Keytruda extend to three years (Reuters)
• In mifepristone case, the Supreme Court must affirm the FDA’s authority. Medical innovation is at risk (STAT)
• New federal rules demand transparency into AI models used in health decisions (STAT)
• Did the FTC have a good reason to block the Sanofi-Maze deal? (Endpoints)
• Sanofi and AstraZeneca to make 230,000 additional RSV immunizations available, White House says (Endpoints)
• Biden administration to impose inflation penalties on dozens of drugmakers (Reuters)
• In wake of Philips recall, senators urge review of FDA medical device oversight (MedTech Dive)

• Medtech Further Examines Repercussions Now EU On Cusp Of Adopting World-First AI Act (MedTech Insight)
• Europe’s lessons for the U.S. on how to cover weight loss drugs (STAT)
• Apellis expects EU to reject eye drug; Terray teams up with Bristol Myers; Vandria raises $20M (Endpoints)
• Novo Nordisk to boost oral GLP-1 manufacturing via $92.4M buy for Alkermes’ Ireland facility (Endpoints)
• UK Regulator To Simplify ‘Yellow Card’ Safety Reporting System (Pink Sheet)

• Jay Bradner, former Novartis research leader, to head up Amgen’s scientific efforts (STAT)
• Gene therapy offered this 7-year-old freedom. The price: a grueling year (STAT)
• After decade-long dispute over CRISPR-Cas9, Editas strikes deal with Vertex to cash in (STAT)
• 'Wonderful Christmas gift': Fed's surprise rate-cut plan springs hope of 2024 biotech market rebound (Endpoints)
• Former execs from Pfizer obesity drug program have started a new biotech with $52M from VC fund ATP (Endpoints)
• Publicis Health names new chief executive from its agency network (Endpoints)
• Playground raises $410M fund, Artis closes $200M as biology and tech VC convergence continues (Endpoints)
• NightHawk becomes pure-play CDMO; Lonza to make liver cancer drug; BioNTech gears up to open first site in Africa (Endpoints)
• Exclusive: Renowned immunology leader 'Skip' Virgin is out as Altos Labs medical chief (Endpoints)
• Updated: Metabolic drug developer HighTide Therapeutics eyes $36M raise with HK IPO (Endpoints)
• Pathos AI makes successful takeover bid for Rain Oncology (Endpoints)

• Medtronic snags first pulsed field ablation approval in US (MedTech Dive)
• Resmed hails ‘significant victory’ as patent board rules in dispute with NYU (MedTech Dive)
• The FDA approved 2 renal denervation devices. There are still questions about who will benefit (MedTech Dive)
• Integra to buy J&J’s Acclarent for $275M (MedTech Dive)
• Illumina prepares to divest Grail with Form 10 filing (MedTech Dive)

• Sanofi ends deal for a rare disease drug after FTC voices monopoly concerns (STAT)
• Upcoming FDA Reorg Overhauls Office of Regulatory Affairs (MedTech Insight)
• Humana used algorithm in ‘fraudulent scheme’ to deny care to Medicare Advantage patients, lawsuit alleges (STAT)
• Morning Rounds: For kids with high BMI, task force not ready to recommend weight loss drugs (STAT)
• US FDA warns Chewy, others over selling unapproved animal antibiotics (Reuters)
• FDA Creates a New Advisory Committee for Genetic Metabolic Diseases – Could This Be an Opportunity to Support Rare Disease Product Development More Broadly? (FDA Law Blog)