Recon: Sanofi, Regeneron expand partnership after Dupixent success; Lilly amylin-Zepbound combo succeeds in mid-stage trial

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

In Focus: US

• HHS announces new efforts to speed up, expand clinical trials with AI (STAT) (BioSpace)
• US Senate committee advances Nicole Saphier as Surgeon General nominee (Reuters) (AP News)
• Testosterone use in women: FDA urges sponsors to try again despite failures (Pink Sheet)
• FDA hits second Fresenius site with contamination-related warning letter in less than a month (Fierce Pharma)
• Top House advocates for psychedelics hear mixed opinions on provider credentialing (Endpoints)
• Merck’s ifinatamab deruxtecan BLA withdrawal highlights accelerated approval’s hidden risks (Pink Sheet)
• FDA starts review of Roche’s multiple sclerosis pill (BioPharma Dive)
• October could see FDA approval actions cool after torrid summer (Pink Sheet)
• FDA built oral Wegovy’s approval on a bridge from Novo’s injectable GLP-1 (Pink Sheet)

In Focus: International

• Australia sets five-year transition to new medicines labeling standards (Pink Sheet)
• GMP failures drive duplicate inspections despite gains in global API oversight (Pink Sheet)
• Industry invited to shape UK regulator’s AI medicines sandbox (Pink Sheet)
• EU medtech AI regulation still has a long way to go, scientists say (Pink Sheet)
• Europe’s 'forever chemicals' proposal and the impact on pharma (The Pharma Letter)
• Hansoh’s Tagrisso rival loses EU approval after AstraZeneca legal challenge (Fierce Pharma)
• Netherlands reports four more deaths from West Nile virus (Reuters)
• In Shanghai’s ‘Science City,’ China’s ascendant biotechs make their pitch to the world (STAT)
• America’s biotech race with China must be won at home (STAT)

Pharma & Biotech

• Sanofi, Regeneron expand partnership after Dupixent success (STAT) (BioSpace)
• Varda gets $251M to make medicines in space, a long-sought area for drugs (Endpoints) (Fierce Pharma)
• Lilly's amylin-Zepbound combo posts best-ever weight loss in patients with obesity and diabetes (Endpoints) (STAT)
• Samsung Bioepis and Teva expand strategic partnership (The Pharma Letter)
• Atara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again (BioSpace)
• Merck's tulisokibart hits primary endpoint in first phase 2 anti-TL1A dermatology trial (The Pharma Letter) (Fierce Biotech)
• Zasocitinib delivered superior efficacy versus deucravacitinib, says Takeda (The Pharma Letter)
• Boehringer's weight loss candidate trails rivals in diabetes and obesity (Endpoints)
• Regeneron's antibody helps patients regain muscle after stopping GLP-1 therapy (Endpoints)
• Invivyd’s pursuit of a Covid vaccine alternative gets a lift, but an FDA hurdle may await (STAT)

Medtech

• Oura delays IPO (MedTech Dive) (Endpoints)
• Abbott launches Freenome’s colorectal cancer screening test (MedTech Dive)
• EU puts AI and EHDS at center of cardiovascular screening plan (Medtech Insight)
• GE HealthCare hires new global chief AI officer (MedTech Dive)
• Sofinnova raises 82M euros to fund medtech startups (MedTech Dive)
• Carlsmed names new CFO (MedTech Dive)
• From IVF to at-home testing: How elective egg-freezing is redrawing fertility medtech (Medtech Insight)

Food & Nutrition

• CDC declares end to Salmonella outbreak traced to backyard flocks (Food Safety News)
• New Listeria outbreak under investigation (Food Safety News)
• Italian reports cover Cyclospora and Salmonella cases (Food Safety News)

Government & Legal

• CMS finalizes GLOBE rule as projected Medicare savings fall from $11.9B to $440M (Endpoints) (STAT)
• Lawmakers urge Trump to rethink new rule that could restrict imported meds from Canada and overseas (STAT)
• New biotech alliance tells Congress to fight for US dominance (Endpoints)
• US says two Indian nationals indicted in counterfeit Ozempic smuggling scheme (Reuters) (FDA)
• Two key Senate health committees face major shake-ups (STAT)
• US poised to boot legal immigrants from Medicaid, including refugees and sex-trafficking victims (STAT)
• Beam Therapeutics sues Chinese biotech, VC-backed startup, alleging theft of intellectual property (STAT) (Endpoints)
• Three GOP states go to US Supreme Court to challenge three Democratic-led states’ abortion ‘shield’ laws (AP News)
• A cure for ‘medical tyranny’: RFK Jr. puts a positive spin on AI (Politico)
• Rural MAHA followers say Trump hasn’t improved health of their communities, poll finds (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.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.