Recon: Revolution's pancreatic cancer therapy improves survival, QOL; Oura adding blood pressure feature after FDA policy change

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

In Focus: US

• The hidden history of BPC-157, a favorite MAHA peptide (STAT)
• Moderna and other groups get $60 million to develop Ebola vaccine (Reuters)
• Servier to buy Edgewise Therapeutics’ muscular dystrophy drug (STAT)
• Executives reveal tech initiatives at Summa Health, eight months after General Catalyst acquisition (STAT)

In Focus: International

• Akeso lung cancer drug helps patients live 15% longer than immunotherapy in China trial (Reuters)
• Apotex Health seeks to raise up to C$1.2 billion, potentially reviving Toronto IPO market (Reuters)
• Lilly enters GLP-2 space in deal with Korea's Hanmi, also forges discovery pact with China's Haisco (Endpoints)
• Summit Falls as Chinese Data on Cancer Drug Fails to Impress (Bloomberg)
• Is European ‘Reliability’ Enough In The Moving Picture Of Global Markets? (MedTech Insight)

Pharma & Biotech

• Practice-changing results reported for Revolution Medicines pancreatic cancer drug (STAT), (Bloomberg)
• J&J prostate cancer drug reduces risk of spread and death in late-stage study (Reuters)
• Experimental Novartis radiopharma drug shows promise in early study (Reuters)
• AstraZeneca's triplet combo succeeds in some liver cancer patients (Endpoints)
• Turn Therapeutics' eczema drug shows rapid response in mid-stage data (Endpoints)
• Kelonia Therapeutics delivers impressive in vivo CAR-T update (Endpoints)

Medtech

• Natera’s Solomon Moshkevich on how MRD testing pinpoints cancer recurrence (MedTech Dive)
• Ōura to add blood pressure feature following FDA policy change (MedTech Dive)
• A Technology Problem Disguised As A Trust Problem: J&J’s Polyphonic Chief On Scaling Surgical AI (MedTech Insight)
• Ten-Year Data Show Edwards’ RESILIA Tissue Valves Hold Up Even In Younger Patients (MedTech Insight)

Food & Nutrition

• SNAP waivers could lead to $830M sales loss for soda, candy, energy drinks (Food Dive)
• The Litigated Dish: Climate change may be helping Salmonella become more drug-resistant (Food Safety News)

Government, Regulatory & Legal

• No Surprises Act arbitration rule could worsen flood of provider disputes (STAT)
• For prostate cancer patients set on surgery, new hormone regimen may improve outcomes, study finds (STAT)
• Medicare still won’t say how much covering obesity drugs will cost (STAT)
• California attorney general sues over 23andMe data breach (MedTech Dive)

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.