Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer cases

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

In Focus: US

• FDA orders new eye risk warnings for Ozempic, Zepbound (Reuters)
• FDA launches investigation of Novartis’ Zolgensma after cancer cases (Endpoints) (Reuters)
• J&J’s Rybrevant nets FDA approval in head and neck cancer (Endpoints) (FDA)
• FDA declines to approve Novocure's lung cancer device (Reuters)
• FDA creates cross-product supply chain council in new Office of National Health Security (Pink Sheet)
• MFN revisions, codification unlikely in divided US government, Pfizer’s Bourla suggests (Pink Sheet)
• Ad/promo: Multiple FDA advisory comment requests OK, but know their limits (Pink Sheet)
• FDA biologics center joins hiring binge, posts first net gain since pre-Trump administration (Pink Sheet)
• The PATIENT AI act: A new prescription for FDA software review, or more of the same? (FDA Law Blog)

In Focus: International

• Pharming wins MHRA approval to expand Joenja indication (The Pharma Letter)
• Caldera, Evommune sign China licensing deals for autoimmune drugs (Endpoints)
• Astellas exec calls for more coordinated EU drug access rules (The Pharma Letter)
• Industry fears making EU sandboxes ‘too exceptional’ will backfire on innovation (Pink Sheet)
• Ethics committees divided on value of UK trial diversity plans (Pink Sheet)
• EU risks ‘completely screwing up’ pharma sandboxes, academic warns (Pink Sheet)
• Recruitment to industry trials falls for fifth year in UK despite faster approvals (Pink Sheet)
• UK flexibility on non-OECD data could widen trial opportunities (Pink Sheet)
• EU pharma sandbox plans risk national regulatory pushback, EFPIA warns (Pink Sheet)
• MFN: EU anti-coercion instrument could counter US drug pricing threats (Pink Sheet)

Pharma & Biotech

• Argenx to acquire Unnatural Products in deal worth up to $1.15B (Endpoints) (Bloomberg)
• Vir says hepatitis D drug combination succeeds in first pivotal study (Endpoints) (Fierce Biotech)
• J&J's once-daily pill eases psoriatic arthritis symptoms in late-stage trial (Reuters) (The Pharma Letter)
• Immunocore's T cell engager combo shows early potential in uveal melanoma (Endpoints)
• Sarepta quits enrolling for confirmatory Phase 3 trial of Elevidys (Endpoints)
• Merck unwraps biopsy data for MASH drug it got from South Korea's Hanmi (Endpoints)
• Zura Bio's skin disease drug fails mid-stage trial (Reuters)
• Hims & Hers inks deal with Eli Lilly to offer branded weight loss drugs (Fierce Healthcare)
• Why the latest heart drug failures should make us all more skeptical of AI hype (STAT)

Medtech

• Siemens Healthineers to rebrand and separate its IVD business (MedTech Dive) (Medtech Insight)
• BD growth platforms lead fourth quarter as Alaris comparison weighs on fiscal 2027 (Medtech Insight)
• Device makers should start preparing for FDA genAI oversight now, MethodSense CEO says (Medtech Insight)
• Cardinal Health raises FY2027 guidance despite 28% profit drop in medical products segment (Medtech Insight)
• Reimbursement before approval: Blue Arbor’s strategy to avoid a common device trap (Medtech Insight)
• Solventum counts on penetration, not market growth, to power growth after HIS exit (Medtech Insight)

Food & Nutrition

• Food industry pushes back on WHO guidance for products with added colour, sweeteners (Reuters)
• US government tells food retailers to take refrigerators off the internet due to malicious cyberattacks (Food Safety Magazine)
• FDA finds Listeria on surfaces at California salsa maker (Food Safety News)

Government & Legal

• Medicare will cut billions from 340B, expand site-neutral payments in 2027 (MedTech Dive)
• States sue Trump administration again to delay Medicaid work requirements (STAT)
• BIO joins the legal fight against Medicare pilot that ties drug prices to peer countries (STAT)
• CMS finalizes combo drug policy as botox ruling clouds negotiation authority (Pink Sheet)
• GSK, Moderna settle patent dispute over Moderna COVID, RSV shots (Reuters)
• Justice Department joins Texas lawsuit against Planned Parenthood (Reuters)
• Head of family physician group seeks more congressional control over ACIP (Endpoints)
• Two incoming lawmakers plan to defend health equity from Trump administration cuts (STAT)
• MAHA leader Calley Means castigates White House officials as bending to industry (STAT)
• In America’s measles epidemic, RFK Jr. is now on trial (Politico)

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.