Recon: Lilly reports 28% body weight loss in Phase 3 trial of new obesity drug; FDA to hold adcomm for Moderna flu vaccine

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

In Focus: US

• US FDA to hold expert committee meeting to review Moderna's flu vaccine (Reuters)
• Lilly’s ‘triple-G’ drug leads to bariatric-surgery levels of weight loss in trial (STAT)
• Lower cost Novo, Lilly weight-loss pills draw patients from compounded drugs, doctors say (Reuters)
• Congressional Democrats try to force a vote to end Medicare AI prior authorization pilot (STAT)
• Dark times ahead at the FDA (STAT)
• After warning letter, Whoop and FDA in discussions about controversial blood pressure feature (STAT)

In Focus: International

• Congo Ebola outbreak cases are 'top of the iceberg', coalition says (Reuters)
• India's top condom maker may hike prices on war-linked oil surge (Reuters)
• UK commits $26.87 million to contain Ebola outbreak in DRC (Reuters)
• Uganda Urges US to Rethink Funding Cuts as It Battles Ebola (Bloomberg)

Pharma & Biotech

• Hims offers Apotex's generic semaglutide in Canada after Novo patent expiry (Reuters)
• Exclusive: Another I&I biotech draws top-tier investors in $180M Series A (Endpoints)
• Driven by GLP-1s, pharma’s relationship with consumers is starting to change (Endpoints)
• Fetal gene therapy inches closer. Will embryo editing follow? (Endpoints)
• Ipsen details growing pains as teens transition to adult care (Fierce Pharma)
• Amgen lures new CFO back from Galderma with hefty bonus (Fierce Pharma)
• Gilead inks another deal with Korean API manufacturer Yuhan, this time worth $140M (Fierce Pharma)
• BeOne kicks off ‘One Save Changes Everything’ campaign with Tim Howard (Fierce Pharma)
• CG Life appoints Collette Douaihy as chief creative officer as C-suite buildout continues (Fierce Pharma)

Medtech

• Medical product maker Convatec warns of higher cost from Iran War (Reuters)
• Medtronic to buy SPR Therapeutics for about $650M (MedTech Dive)
• Medtronic data back renal denervation in the long term (MedTech Dive)
• Endologix buys clot removal system from Surmodics (MedTech Dive)
• Hyperspectral Imaging Aims To Give Surgeons ‘Superhuman’ Insight (MedTech Insight)

Food & Nutrition

• Celebrity beverages are crowding the spotlight (Food Dive)
• Independent grocers make up nearly 40% of US food retail sales, report says (Food Dive)

Government, Regulatory & Legal

• ‘Axe the Fax’: CMS Doubles Down On Efforts To Modernize Prior Authorization (MedTech Insight)
• US Response to Ebola in Africa Aims to Stop Virus From Reaching America (Bloomberg)
• US Senator Durbin urges RFK Jr. to resist easing vape rules (Reuters)
• US Enlists Small Biotech for Experimental Ebola Treatment (Bloomberg)
• US Ebola Spending Plunged 99% in Five Years Since Last Outbreak (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.