Recon: Amgen plans $300M manufacturing expansion in Puerto Rico; France fines Novo, Lilly over weight-loss drug ads

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

In Focus: US

US Supreme Court lets abortion pill mail delivery restart for now (Reuters)
Moderna in talks with FDA over post-marketing Covid shot data, with eyes on wider access (Endpoints)
Paranoia, Turmoil and Backlash: Inside the FDA Under Marty Makary (Bloomberg)
FDA Announces New Real-Time Clinical Trial Initiative to Expedite Development, but at What Cost? (FDA Law Blog)
FDA expectations create potential friction in new Form 483 response guidance (Fierce Pharma)
Warned off vaccine actions, Kennedy seeks quick health wins ahead of midterms (Reuters)

In Focus: International

French regulator fines Novo and Lilly over weight loss ad campaigns (STAT)
China’s strict new supply chain regulations could create massive problems for Western biopharma companies (STAT)
Windward Bio gets $165M to take China-derived drug into Phase 3 asthma trial (Endpoints)
Acelyrin founder Shao-Lee Lin emerges at Cue, as it becomes latest to license from China (Endpoints)
Zambia says US health deal must be uncoupled from minerals access (Reuters)
Evacuations planned as suspected hantavirus outbreak traps 150 on ship off Cape Verde (Reuters)

Pharma & Biotech

Weight-loss revolution sparks new appetite for aesthetics firms (Reuters)
Amgen to invest additional $300 million to boost US manufacturing footprint (Reuters)
Biotech raises $42 million to run Huntington’s disease trial (STAT)
Takeda's next-gen experimental immune drug comparable to approved treatment in study (Reuters)
Amgen launches late-stage obesity trial in patients who switch from rival drugs (Endpoints)
Biotech firm Odyssey targets $810 million valuation in US IPO (Reuters)
UCB bets $2B on Candid's T cell engager ambitions (Endpoints)
Q&A: Seaport CEO and CSO on learning from Karuna and the future of CNS research (Endpoints)
Samsung Biologics workers begin five-day strike over wage disputes (Endpoints)
Carlyle Acquires Healthcare RCM Providers Knack and EqualizeRCM (Bloomberg)
FDA hands Pfizer, Arvinas’ Veppanu early approval for breast cancer subtype (Fierce Pharma)
Cardio drug developer Esperion to go private in potential $1.1B buyout by ArchiMed (Fierce Pharma)
Summit's PD-1xVEGF interim trial miss surprises analysts, shares tumble (Fierce Pharma)

Medtech

Medical Device Maker Mobia Seeks to Raise $160 Million in US IPO (Bloomberg)
Tariffs Drag Down Profits For Cardinal’s Medical Products Division, Even As Overall Revenues Up 11% (MedTech Insight)
Dexcom Posted Strong Q1 Results; Medicare CGM Coverage Will Be Key For Growth (MedTech Insight)
Illumina ‘Off To A Great Start’ As Company Raises Full-Year Outlook On Strong Earnings (MedTech Insight)
ResMed Says GLP-1s Won’t Affect Business As Earnings Beat Expectations (MedTech Insight)
Robotic Mastectomy Comparable To Open Surgery, But Ergonomics May Shift Surgeon Preference (MedTech Insight)

Food & Nutrition

‘Forever chemicals’ in baby formula? Scientists unpack FDA results (STAT)
New York poised to become first state to close food ingredient ‘loophole’ criticized by RFK Jr (Food Dive)

Government, Regulatory & Legal

Immigration changes are driving foreign researchers to leave the U.S. — or not come to begin with (STAT)
State Healthcare Sites Are Sharing Personal Data with Big Tech (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.