Recon: ImmunityBio’s Anktiva clears FDA expansion in bladder cancer; “Gross contamination” found at Chinese site manufacturing GLP-1 components

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

In Focus: US

• FDA clears ImmunityBio’s Anktiva expansion in bladder cancer after regulatory whiplash (Fierce Pharma) (FDA)
• New FDA framework favors consistency over flexibility on rare disease drugs (Endpoints) (FDA)
• FDA generic drugs office director steps down amid ‘political pressure,’ admin burden (Pink Sheet)
• Former FDA officials blast DOGE as ‘one of the biggest disasters in American history’ (STAT)
• FDA eager to accelerate pediatric lupus research, change ‘tedious’ label update process (Pink Sheet)
• FDA cell and gene therapy adcomm is latest to shrink core voting membership (Pink Sheet)
• Ultragenyx makes swift $413M return on FDA review vouchers after summer of gene therapy nods (Fierce Pharma)
• The first new sunscreen type in 25 years has arrived on US store shelves (AP News)

In Focus: International

• Revolution Medicines wins EU committee backing for pancreatic cancer treatment (Reuters)
• Sanofi avoids fine as EU accepts offer to end antitrust probe over disparaging rival vaccine (STAT) (The Pharma Letter)
• South Africa revises rules around customisation of weight-loss drugs (Reuters)
• Malaysian pharmacy group Big Caring signs retail underwriting deal ahead of IPO (Reuters)
• Guinea-Bissau says it has not approved hepatitis B vaccine trial in newborns (Reuters)
• GSK could cut more than 1,200 jobs in Belgium (Endpoints) (BioSpace)
• EMA to tackle evidence hurdles for inherited retinal dystrophy candidates (Pink Sheet)
• Seven-year UK pharma pricing deal takes shape amid dispute over spending targets (Pink Sheet)
• European payers worried over regulatory sandboxes and evidence quality (Pink Sheet)
• NHS England delays commercial framework for medicines review as access reforms broaden (Pink Sheet)

Pharma & Biotech

• BlackRock to buy majority stake in Humana’s CenterWell clinics for $2.8 billion (STAT)
• Galderma bulks up dermatology portfolio with $1.5B acquisition of Zo Skin Health (Fierce Pharma) (Reuters)
• Gilead snags equity stake in Vir with up to $1.87B deal for three T cell engagers (BioSpace) (Endpoints)
• AstraZeneca inks $1.5B insitro deal for AI-enabled target discovery of liver, heart disease drugs (Fierce Biotech) (Bloomberg)
• Zealand inks up to $1.3B deal for AI-designed obesity treatments (Endpoints) (Reuters)
• Black mold, bugs found at Chinese plants making GLP-1 compounding agents (Bloomberg)
• IQVIA, Veeva expand on existing partnership for speedier clinical trials (Fierce Biotech)
• Verastem reports ‘robust’ response rate in pancreatic cancer subgroup where Rasonque struggled (BioSpace) (Endpoints)
• Vanda’s social anxiety drug flunks Phase 3 trial in female patients (Endpoints) (Reuters)
• Verdiva ends mid-stage study of oral GLP-1 amid ‘market evolution’ (BioSpace) (Fierce Biotech)

Medtech

• Steris inks $2.1B Xodus buyout to expand consumables portfolio (MedTech Dive)
• Orthofix pays former executives $24M in damages (MedTech Dive)
• ‘AI-native’ Notified Body Scarlet bucks sector woes with $50M funding (Medtech Insight)
• Consumer health firms should shape AI standards for self-care products, expert says (Medtech Insight)

Food & Nutrition

• FDA quietly included provision in GRAS proposed rule to expand one ‘loophole’ while tightening another (Food Safety Magazine)
• Consumer Reports wants FDA official to explain the agency's response to the Cyclospora outbreak (Food Safety News)
• Pennsylvania advances bill that would set limits on heavy metals in baby foods (Food Safety Magazine)
• Spanish authorities urged to share Salmonella outbreak details (Food Safety News)

Government & Legal

• Trump administration delays new rule that could restrict imported medicines from Canada and overseas (STAT)
• Medicare Part D plans stabilizing but 2030 premium cliff needs attention, CMS’ Brooks says (Pink Sheet)
• Could Medicare price negotiation tip the scales toward Part B drug payment reform? (Pink Sheet)
• Lobbyists and trade groups fight to shape how states regulate medical AI (STAT)
• As White House shifts focus toward AI and tech, US science leaders defend role of the American university (STAT)
• United lands 'clear-cut win' as Liquidia agrees to $380M settlement in Tyvaso patent infringement saga (Fierce Pharma) (Reuters)

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.