Recon: FDA rejects ITM radiopharma therapy; WHO defends immunization schedules

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• In surprise decision, FDA rejects radiopharma therapy expected to rival Novartis treatment (Endpoints)
• CMS seeks feedback on faster coverage for breakthrough devices (MedTech Dive) (Medtech Insight)
• Generic drug user fee deals creates domestic-focused incentives, could lower application fees (Pink Sheet)
• When the math isn’t mathin’: FDA’s latest clinical investigator warning letter highlights why drug accountability matters (FDA Law Blog)

In Focus: International

• WHO defends immunization schedules after Trump orders fewer childhood shots (Reuters)
• India raises stakes: Fabricated drug data now risks permanent market exclusion (Pink Sheet)
• Global inspectors prepare for AI-powered pharmacovigilance era under PIC/S (Pink Sheet)
• New transmission from animals likely caused Congo-Uganda Ebola outbreak, study says (Reuters)
• India's Zydus Life quarterly profit slumps as costs weigh (Reuters)

Pharma & Biotech

• Austria’s new growth fund could further bolster its dynamic biotech innovation economy (BioSpace)
• Skylar Bio kicks off new gene therapy trial for deafness (STAT)
• MoonLake Immunotherapeutics isn’t releasing detailed data on its drug candidate (STAT)
• AbCellera’s menopause medicine ‘sets new efficacy bar’ for hot flashes (BioSpace)
• Cardinal Health forecasts full-year profit above estimates on specialty drug strength (Reuters)
• Vaderis fuels up with $152M series B to test rare vascular disease in Phase 3 (BioSpace) (Endpoints)
• Epicrispr, Infinimmune snag combined $165M in VC cash (BioSpace)
• Ying Huang's post-Legend life takes shape at K2, with $250M goal to license Asia assets (Endpoints)
• Scribe’s Benjamin Oakes on a rare IPO and bringing CRISPR to the masses (BioPharma Dive)
• Hims 'able to move extremely quickly' if FDA greenlights six wellness peptides, CEO says (Endpoints)
• Hims & Hers shares slide as costly weight-loss push squeezes margins (Reuters)
• Did Novo’s phase 3 flop kill the inflammation hypothesis in heart disease? (PharmaVoice)

Medtech

• Teledyne inks $1.1B takeover of Varex Imaging (MedTech Dive)
• Ortho firms unfazed by Medicare joint replacement changes (MedTech Dive)
• IRhythm grows heart monitoring leadership with $288M VitalConnect buy (MedTech Dive)

Food & Nutrition

• US FDA urges sanitation, supplier checks to curb fresh-cut produce contamination (Reuters)
• CEOs pushed White House to delay ultra-processed food policy (Bloomberg)
• Somalia malnutrition response hit by more than 80% funding drop as child hunger surges, MSF says (Reuters)

Government & Legal

• IRBs have a problem. Can North Star’s nonprofit model save it? (STAT)
• A federal policy is complicating how organizations battle the opioid crisis (KFF Health News)
• Burdensome Medicare GLP-1 program may keep patients from accessing $50 per month weight loss drugs (STAT)

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.

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