Recon: FDA says Replimune's pivotal melanoma study failed to show benefit; FDA guidance on peptides could affect development of GLP-1 generics

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

In Focus: US

• US FDA staff cast doubt on Replimune cancer drug's benefit; shares slide (Reuters)
• US FDA Peptide Guidance Moves Could Affect GLP-1 Generic Development (Pink Sheet)
• Preliminary trial results suggest a path to a safer Alzheimer’s treatment (STAT)

In Focus: International

• HIV resurgence is feared as global funding to combat the disease falls 18% (STAT)
• A day in the life of Congo's overstretched Ebola surveillance teams (Reuters)
• GSK to invest £400 million in Britain over three years as it ramps up R&D efforts (Reuters)
• Spain’s No To Kisunla, Leqembi Funding Draws Backlash As UK’s NICE Reconsiders (Pink Sheet)
• Canada’s Top Court Backs Janssen’s Invega Patent, Adopts ‘Balanced’ Position On Dosing IP (Pink Sheet)

Pharma & Biotech

• From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD (STAT)
• GSK lays out plans to cut costs, pursue more late-stage drug trials (STAT)
• Dementia finally has a business model (STAT)
• Alnylam's stock is down 30% despite a booming biotech market. Here's why. (Endpoints)
• Updated: AstraZeneca foresees blockbuster sales for Claudin 18.2 ADC, but Ultomiris flops in rare disease (Endpoints)
• Exclusive: Mirae raises $5.4M to turn patient texts into data for doctors (Endpoints)
• Capricor’s Changing Trial Protocols Could Undermine Deramiocel At US FDA AdComm (Pink Sheet)
• BC Partners Agrees to Buy Stake in Pharma Firm InfoRLife (Bloomberg)

Medtech

• Boston Scientific to restructure, taking up to $800M in charges (MedTech Dive)
• Why Aidoc is taking a generative AI device to the FDA (MedTech Dive)
• Philips largely recoups struck-down Trump tariffs in Q2 (MedTech Dive)
• EssilorLuxottica Doubles AI Glasses Sales in Second Quarter (Bloomberg)

Food & Nutrition

• US to lift Mexico cattle ban to combat high beef prices (Food Dive)
• Grocery volumes contract for fifth consecutive month, report finds (Food Dive)

Government, Regulatory & Legal

• CMS evaluates one year of health tech progress, announces eight new pledge categories (STAT)
• Centene flags weakening Medicaid membership, shares fall (Reuters)
• Women’s Oncology Market Expected To Reach $110Bn By 2030, Gynecologic Cancers Remain Underfunded (MedTech Insight)
• J&J Aims to End 15-Year Talc Fight With $5.5 Billion Settlement (Bloomberg)

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.