Recon: FDA expands labels for J&J’s Imaavy, Jazz's Ziihera; Teva faces Turkish antitrust probe over patent moves

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

In Focus: US

• FDA approves Jazz's Ziihera in frontline gastric cancer (Endpoints)
• FDA expands approval for J&J's drug for rare blood disorder (Reuters) (Fierce Pharma)
• Avulux wins FDA de novo authorization for special lens to reduce migraine-related light sensitivity (Medtech Insight)
• Payers limited animal-derived thyroid drugs before FDA delayed guidance, enforcement (Pink Sheet)
• Comments on OMB research rule mysteriously removed from federal website (STAT)
• FDA's testosterone workshop starts from acknowledged uncertainty (Pink Sheet)
• FDA addresses device constituents in new draft guidance on container closure systems (FDA Law Blog)
• Vitruvias Therapeutics issues nationwide recall of thyroid tablets due to potential super potency (USA Today) (BioSpace)
• Two dead from measles in Pennsylvania, state health department says (Reuters)

In Focus: International

• Turkish antitrust authorities probe Teva for allegedly gaming the patent system, disparaging rival drugs (STAT)
• OmicsBank raises $2.25M to bring overseas patient data to biopharma (Endpoints)
• China’s Haisco forms immunology biotech with up to $1.5B from American VCs (Endpoints) (BioSpace)
• Hungary foreign ministry files report on $964 million pandemic-era ventilator deals (Reuters)

Pharma & Biotech

• Bristol Myers ends deal with Cellares, cell therapy manufacturer to reorg (Endpoints)
• McKesson strikes $2.25 billion Precision Medicine deal in clinical research bets (Reuters)
• Bausch + Lomb plans Phase 3 trial for dry eye drop, despite missing mid-stage goal (Endpoints)
• Preparing for Novartis showdown, Curium touts value of radiopharma supply resiliency (BioSpace)
• Lundbeck strikes expanded pact with Eversana to broaden AI scope across US commercial business (Fierce Pharma)
• Hansa lays groundwork for Nasdaq debut ahead of US kidney transplant drug verdict (Fierce Pharma)

Medtech

• Qiagen names new CEO (MedTech Dive)
• Axoft announces latest iteration of its soft, fleuron-based materials for research use (Medtech Insight)
• Whoop brings wearable health technology to Medicare beneficiaries (Medtech Insight)
• Fitbit creators unveil screenless wearable to help track aging parents (Bloomberg)
• Medtech’s 2026 playbook: Buy into growth, sell out of slower assets (Medtech Insight)

Food & Nutrition

• India wanted red flags on chip packets and soda. Big Food fought back (Reuters)

Government & Legal

• Merck, AZ lawsuits against Medicare price negotiations swatted down (Fierce Pharma)
• US lawmakers question Health Secretary Kennedy on vaccine settlement disclosures (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.