Recon: FDA grants breakthrough designation to gen AI radiology tools; Oncology paper retraction casts doubt on China research

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

In Focus: US

• FDA gives generative AI in radiology two breakthrough designation nods (STAT)
• Democrats press White House on who got special access to Eli Lilly’s new obesity drug (STAT)

In Focus: International

• Biosecure didn’t stop China’s rise in biotech. Some lawmakers want to do more (STAT)
• Retraction of high-profile paper on cancer drug timing could hand ammo to China hawks (STAT)
• Merck KGaA makes largest deal in a decade in $11.3B buy for Bio-Techne (Endpoints) (Reuters)
• EU Set To Beat 2030 Target For EHR Access (MedTech Insight)

Pharma & Biotech

• Facing a brutal run, battered vaccine makers still see cause for hope (STAT)
• Ollin refuels with $330M to back pivotal tests of Vabysmo challenger (BioPharma Dive)
• Eli Lilly dives into hair loss treatments with investment in AI startup Absci (STAT)
• Next-gen CRISPR tools improve editing accuracy in embryos, but also stoke ethical concerns (STAT)
• How GSK's new CEO lined up a major buyout to start his time at the top (Endpoints)
• Compounder Olympia Pharmaceuticals eyes peptide opportunity (Endpoints)
• Antares gets $105M from Novartis for new cancer drugs (BioPharma Dive)
• Investors pour $115M into RQ Bio in search of a preventive flu drug (BioPharma Dive)

Medtech

• Tissium secures up to $68M to back rollout of nerve repair platform (MedTech Dive)
• FDA drops Whoop warning letter over blood pressure feature (MedTech Dive)
• MiniMed launches Abbott-made Instinct glucose sensor in Europe (MedTech Dive)
• Adhesives Giant H.B. Fuller Pushes Into Surgical Devices With £715m AMS Buy (MedTech Insight)

Government, Regulatory & Legal

• Novo's top US exec wants more insurance coverage for weight-loss drugs (Reuters)
• Riders on the Storm Part 2: The Drug Provisions (FDA Law Blog)
• Bipartisan bill seeks to allow direct prescribing of methadone for opioid addiction (STAT)
• US health spending spikes to $5.7T in 2025, though growth should moderate, CMS finds (MedTech Dive)
• One Normal FDA Meeting Isn’t Enough (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.