Recon: Kennedy urges Americans to quit SSRIs; BioNTech to scale back production, cut 1,860 jobs

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

In Focus: US

Kennedy Starts a Push to Help Americans Quit Antidepressants (The New York Times) (HHS)
Drug pricing deal to generate savings of $64.3 billion over 10 years, White House says (Reuters)
FDA commissioner defends agency’s drug approval decisions after wave of backlash (CNBC) (Reuters)
Axsome increases Auvelity's peak sales projection to $8B (Fierce Pharma)
Bipartisan senators press Trump admin on funding vaccines for poor countries (The Hill)
Use of Gilead's HIV prevention shot rises, but US insurance gaps remain (Reuters)

In Focus: International

Swiss manufacturing, biotech industry so far unfazed by geopolitics (Endpoints)
Novartis cuts 220 jobs as it closes German site (Fierce Pharma)
BioNTech to slash 1,860 jobs, exit sites in Germany and Singapore in major manufacturing pullback (Fierce Pharma)
Sanofi expands AI capabilities, investing $294M to scale Toronto hub (Fierce Pharma)
Human to human hantavirus transmission suspected on cruise but risk to public low, WHO says (Reuters)

Pharma & Biotech

Cytokinetics drug Myqorzo meets twin efficacy goals in study of genetic heart disease (STAT)
Johnson & Johnson advances IBD therapy, despite trial miss (STAT)
Exclusive: One cancer survivor's super poop is behind microbiome startup's $48M raise (Endpoints)
Madrigal extends MASH deal streak with Arrowhead drug that J&J didn't want (Endpoints)
Pfizer cuts final Trillium-related program, but R&D spend jumps on cancer, obesity studies (Endpoints)
Vertex drops mRNA cystic fibrosis program over 'tolerability' issues (Endpoints)
Pfizer posts strong first-quarter, sees boost from recent legal wins (Reuters)
Viridian eye disease drug surpasses expectations in late-stage trial; shares soar (Reuters)
Novo Nordisk's weight-loss pill boom faces price war test (Reuters)
Prolific's light-controlled manufacturing system sets mAb record (Fierce Pharma)
Leo Pharma Eyes $800 Million Deal Push as IPO Plans Advance (Bloomberg)

Medtech

Edwards names Theodora Mistras as CFO (MedTech Dive)
Olympus, EndoRobotics forge distribution pact (MedTech Dive)
How A Cigarette Legal Battle Could Change AI Medtech Regulation (MedTech Insight)
Lack Of Growth Troubles German IVD Sector (MedTech Insight)
FDA Updates Medical Device Charging Guide With Warning Against Liquid Spillage (MedTech Insight)
IVL Competition Heats Up As Medtech Giants Circle The Market (MedTech Insight)

Food & Nutrition

Popular potato chips recalled over salmonella concerns (The Hill)
Democrats seize on MAHA’s growing frustration with GOP (The Hill)

Government, Regulatory & Legal

Mifepristone court ruling makes drug development riskier for everyone (STAT)
Trump Pressures FDA Commissioner to Approve Flavored Vapes (WSJ)
Top lawmaker takes aim at doctor lobby, linking AMA’s billing codes to fraud fight (STAT)
Healthcare organizations are increasingly building their own AI tools (Endpoints)
Parsley Health goes in-network nationwide (Endpoints)
Pennsylvania sues Character AI, says chatbot poses as doctors (Reuters)

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.