Recon: FDA denies Replimune’s cancer drug over trial issues; Revolution’s cancer pill boosts survival in Phase 3 trial

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

In Focus: US

• Amazon to stock Lilly's new weight-loss pill at US kiosks, offer same-day delivery (Reuters)
• Landmines await Vinay Prasad’s successor at the FDA (STAT)
• FDA rejects Replimune cancer therapy, saying company didn't resolve trial doubts (Endpoints)
• Medline Recalls Millions Of Angiographic Syringes After FDA Warning Letter (MedTech Insight)
• Plausible Mechanism Case Studies: Why US FDA Guidance Matters (Pink Sheet)
• FDA’s Fiscal Year 2027 Budget is Chock-Full of Legislative Proposals – Especially on Hatch-Waxman and the BPCIA (FDA Law Blog)

In Focus: International

• Bayer pharma executive predicts US-Europe price spreads will narrow (Endpoints)
• A ‘cure’ for five blood disease patients suggests Chinese genetic medicine can compete globally (Endpoints)
• South Korea bans stockpiling of medical needles, syringes to prevent supply disruptions (Reuters)
• Drugmaker Leo Pharma Is Said to Pick Banks for Copenhagen IPO (Bloomberg)
• Estonia Joins EU Race To Accelerate Clinical Trial Approvals (Pink Sheet)

Pharma & Biotech

• Revolution Medicines touts ‘unprecedented’ data for pancreatic cancer pill (STAT) (Reuters)
• Allogene Therapeutics’ CAR-T treatment eliminates residual cancer cells in B-cell lymphoma patients (STAT)
• Spyre Therapeutics IBD drug shows promise in early trial (STAT)
• Ideaya’s uveal melanoma drug exceeds success benchmark in late-stage trial (Endpoints)
• Kailera, Alamar launch US IPOs as biotech listings gather momentum (Reuters)
• GSK sees blockbuster potential in targeted cancer therapy after promising early data (Reuters)
• PolyPeptide Shares Surge Amid Takeover Interest From EQT, KKR (Bloomberg)
• Regulatory Alignment Helps Cereno Chart Faster, Cheaper Route For CS014 (Pink Sheet)

Medtech

• Stryker is fully operational after cyberattack (MedTech Dive)
• Pulse Biosciences hires Liane Teplitsky as COO (MedTech Dive)
• EU Data Act Brings Yet More Questions For Medtech (MedTech Insight)
• MHRA’s Commatteo Points To Pivotal Period For AI Regulation And Airlock 3 (MedTech Insight)

Food & Nutrition

• Jury orders Abbott to pay $70 million in preterm infant formula trial, company says (Reuters)
• How food manufacturers are rethinking product assortments (Food Dive)

Government, Regulatory & Legal

• Mail-order dominates US abortion pill dispensing (Reuters)
• GAO report shows gap between scale of illegal vapes and enforcement (STAT)
• Hospitals roll out chatbots, looking to reclaim their role in patients’ health conversations (STAT)
• Plan for remade CDC vaccine panel adds focus on vaccine safety, matching Kennedy’s push (Endpoints)
• States, insurers await needed details to implement new US Medicaid work rules (Reuters)
• UMSOM Researcher To Drive Innovation By Making New Cervix ‘Organ-On-A-Chip’ Widely Accessible (MedTech Insight)

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.