Recon: Amazon to sell Lilly’s weight-loss drug at kiosks in US; CDC delays report on COVID vaccine benefits

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)
• CDC delays publishing report showing covid vaccine benefits (Washington Post)
• PhRMA head Steve Ubl to step down at end of year (Endpoints)
• FDA rejects an industry proposal to deregulate some AI devices (STAT)
• Trump promised to clamp down on health insurers. His policies are enriching them (STAT)
• A decade ago, these drugs tore apart the FDA. Today, they might be some patients’ best hope (STAT)
• Patients scramble to find estrogen patches as shortage worsens after US FDA champions use (Reuters)
• FDA And Industry Reach ‘Agreement In Principle’ On MDUFA VI Framework (MedTech Insight)

In Focus: International

• Exclusive: US upends global supply program for malaria and HIV amid warnings of gaps (Reuters)
• Exclusive: China's Ailux adds AstraZeneca vet as CSO in hiring spree while eyeing clinic in 2027 (Endpoints)
• China removes national TV medical advertisements with false claims (Reuters)
• Boston Oncology in cancer drug deal with China's Xuanzhu Biopharmaceutical (Reuters)
• AI Act Updates Risk ‘Consumer Harm’ From Medical Devices, EU Civil Society Orgs Say (MedTech Insight)
• Singapore’s Asian Population Cohort Dataset To Move Forward With Seer’s Proteograph Platform (MedTech Insight)

Pharma & Biotech

• Biotech VCs, used to a winning formula in drug development, face disruption (STAT)
• 5 years after lupus breakthrough, CAR-T is still surprising autoimmunity researchers (STAT)
• Team approach to lowering high blood pressure worked even in ‘a tough landscape’ (STAT)
• Roche dips into DACs with existing partner C4 Therapeutics for $20M upfront (Endpoints)
• Pulmonary fibrosis biotech Avalyn Pharma files for IPO (Endpoints)
• Everyone has a mental health chatbot. Now what? (Endpoints)
• Gilead takes another big swing at expanding beyond HIV (Endpoints)
• C4 Therapeutics, Roche expand partnership with new cancer deal worth over $1 billion (Reuters)

Medtech

• US FDA approves Waters' at‑home cervical cancer screening kit (Reuters)
• One year in: How medtech companies are coping with tariff challenges (MedTech Dive)
• CDRH targets hospital readmissions with home device innovation challenge (MedTech Dive)
• Hologic hires former Baxter leader José Almeida as CEO (MedTech Dive)
• Philips warns not to use certain nebulizers in Trilogy Evo ventilator recall (MedTech Dive)
• CorTec’s CEO Says FDA Breakthrough Marks Shift To Therapeutic BCI For Stroke (MedTech Insight)

Food & Nutrition

• FDA delays approval of 2 natural food dyes following safety objections (Food Dive)
• High gas prices are crimping grocery spending, research finds (Food Dive)

Government, Regulatory & Legal

• As a palliative care physician, I’m nervous about the Medicare infusion of $100 million for ‘functional or lifestyle medicine’ (STAT)
• Kennedy to launch public health podcast ahead of US midterm elections (Reuters)
• McKinsey to contribute $125 million to Purdue bankruptcy over opioid sales advice (Reuters)
• Bipartisan Push for FDA “Pre-Review” of DTC Drug Ads (FDA Law Blog)

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.