Recon: Feds propose Medicare coverage of GLP-1s for weight loss; Roche purchases CAR-T developer Poseida for $1 billion upfront
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- In the MAHA-verse, ex-Bernie die-hards and conservative moms find a political home (STAT)
- Medicare moves to expand coverage for weight-loss drugs Wegovy, Zepbound (STAT)
- Vaccine Head Sees Scope for Support Despite Trump’s RFK Jr. Pick (Bloomberg)
- Trump calls for 25% tariffs on imports from Canada and Mexico (MedTech Dive)
- US FDA Commissioner Nominee Not ‘Pro-Industry Choice,’ GLP-1 Compounding Could Be First Clash (Pink Sheet)
In Focus: International
- Updated: Roche buys out CAR-T partner Poseida for $1B upfront (Endpoints)
- New mpox vaccines for Congo's children held up by old problem (Reuters)
- Germany’s DRGs And Hospital Reform Cleared For January Launch (MedTech Insight)
- EU HTA Regulation A Positive Move For Rare Disease Therapies, says EURORDIS Chief (Pink Sheet)
- UK MHRA Calls On Pharma To Embrace RWD Early (Pink Sheet)
- Deal-Making May Not Be Easier Despite Illumina and Grail’s European Court of Justice Victory (MedTech Insight)
Pharma & Biotech
- Sarepta, Arrowhead Pharmaceuticals partner to advance RNA-based drugs in rare diseases (STAT)
- Amgen drug leads to substantial weight loss in study, but questions remain about competitiveness (STAT)
- Roche records setback in phase III study of two lung cancer drugs (Reuters)
- Food allergy biotech Alladapt closes after Phase 3 talks with FDA (Endpoints)
- Soleno’s rare pediatric disease drug faces PDUFA delay by three months (Endpoints)
- Agilent reveals plans to remodel operations as annual revenue dips (Endpoints)
- Aviceda aims to raise $200M; Nerviano gets back rights to PARP1 inhibitor (Endpoints)
- Shorla gains FDA nod for first oral liquid version of Novartis' Gleevec (Fierce Pharma)
- Guardant awarded $293M in false advertising case against fellow cancer test maker Natera (Fierce Pharma)
- Fast-growing Adragos snaps up Swiss CDMO Baccinex, significantly expanding fill-finish firepower (Fierce Pharma)
Medtech
- Biden administration wants to rein in use of AI in Medicare Advantage, among other fixes (STAT)
- Embecta discontinues insulin patch pump development (MedTech Dive)
- Zimmer wins FDA approval for cementless partial knee implant (MedTech Dive)
Government, Regulatory & Legal
- Government watchdog calls out HHS for not auditing health care’s privacy compliance since 2017 (STAT)
- Inside the telehealth-fueled GLP-1 alternative market (STAT)
- UnitedHealth pays its own physician groups considerably more than others, driving up consumer costs and its profits (STAT)
- Getting into the weeds on marijuana excise taxes: trends and outliers in the largest markets (Reuters)
- New EU Fee Regulation: Smaller Firms & Orphan Drugs Will Still Benefit From Full Reductions (Pink Sheet)
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.
