Recon: Zevra prices newly approved Neimann-Pick disease drug at $106k per month; Novo faces Senate committee grilling over weight loss drug prices

• Zevra Therapeutics prices rare genetic disorder drug at up to $106,000 per month (Reuters)
• Millions of Americans want to quit smoking. Critics say drugmakers and the FDA are failing them (STAT)
• 40 doesn’t look good on Hatch-Waxman (STAT)
• PhRMA scores a small win in legal challenge to Medicare’s drug price negotiation (STAT)
• Wegovy is among drugs set to be targeted in the next round of Medicare price negotiations, researchers say (STAT)
• New HHS rules can’t address the primary reason for research misconduct (STAT)
• Q&A: Bristol Myers’ tech chief on the promises and perils of AI bio (Endpoints)
• FTC Targets PBMs In Lawsuit On Insulin Rebates But Says Pharma Also Culpable (Pink Sheet)
• Novo Nordisk faces US Senate committee grilling over price of weight loss drugs (FT) (Reuters)

• Sanofi CEO believes company poised for growth from new drugs (Reuters)
• UK vaccine startup Vicebio snags $100M to take on GSK, Pfizer and Moderna (Endpoints)
• EU HTA Regulation: Expect The Unexpected When It Comes To PICOs (Pink Sheet)
• Orphans Elahere, Hetronifly & Hympavzi Among Eight New Products Set For EU Approval (Pink Sheet)
• Urgent Action Needed To Address Deficiencies In EU's IVD Regulation – As Well As MDR (MedTech Insight)

• Is Sanofi making a move into obesity? French pharma invests $27M into Ventyx (Endpoints)
• Telix buys radiopharmacy network for $230M up front to expand US capacity (Endpoints)
• Context makes a T cell engager deal; Ginkgo Bioworks backers have a new SPAC (Endpoints)
• AstraZeneca, Daiichi’s TROP2 drug misses overall survival goal in Phase 3 breast cancer trial (Endpoints)
• Black Diamond treads water on small snapshot of Phase 2 lung cancer data (Endpoints)
• Ideaya outlines regulatory path for rare eye cancer drug after positive mid-stage data (Endpoints)
• John Carroll on his cancer diagnosis; #ESMO's biggest surprise; Lykos' bad trip; Rate cuts, and more (Endpoints)
• Regulatory RNA startup CAMP4 files for IPO as more biotechs line up listings (Endpoints)
• Context makes a T cell engager deal; Ginkgo Bioworks backers have a new SPAC (Endpoints)
• Stark Reminders Of Why Antibiotic Space Remains Unattractive On Display At FDA Advisory Cmte. (Pink Sheet)
• Decentralized Trials: FDA Final Guidance Eliminates Need For Local Provider Activity Tracking (Pink Sheet)

• Most cardiovascular devices with serious safety recalls aren’t tested in patients (STAT)
• 4 steps to minimize the threat of legacy medical devices (MedTech Dive)
• Stryker adds devices to remove brain tumors, clots with Nico buy (MedTech Dive)
• FDA posts draft guidance on biocompatibility testing of devices (MedTech Dive)
• Masimo investor claims proxy war win as CEO Kiani fails to retain board seat (MedTech Dive)
• Abbott ramps up Libre 3 production amid shortages (MedTech Dive)
• GE Healthcare wins FDA clearance for Alzheimer’s imaging software (MedTech Dive)
• FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule (FDA Law Blog)

• Electronic health records giant Epic Systems sued over alleged monopolistic practices (STAT)
• A mysterious anti ‘Big Pharma’ bus is barnstorming swing states (STAT)