Recon: Insilico, Eli Lilly strike $2.75B AI drug development deal; FDA clears Butterfly Network’s AI ultrasound pregnancy tool

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

In Focus: US

AI drug developer Insilico Medicine and Lilly ink commercialization deal worth up to $2.75 billion (STAT)
Merck's cholesterol drug meets main goal in head-to-head trial (Reuters)
Butterfly Network gets FDA clearance for AI ultrasound pregnancy tool (Reuters)
Royalty Pharma and J&J partner to develop autoimmune treatment (Reuters)
In private meetings, White House works to win pharma companies’ support for drug pricing bill (STAT)

In Focus: International

China’s biotech boom is rewriting everything (STAT)
Kailera plans IPO to raise money for its China-licensed obesity pipeline (Endpoints)
AstraZeneca’s in vivo CAR-T showed promise against multiple myeloma, but also one death in China trial (Endpoints)
CHMP recommends subcutaneous form of Sanofi's Sarclisa and four new drugs (Endpoints)
Eli Lilly seeks higher NHS drug prices, rebate overhaul to restart UK investment, FT reports (Reuters)
China's Hansoh Pharmaceutical Group beats net profit expectations in 2025 (Reuters)
Russia overhauls vaccine production after cattle disease triggers mass culling (Reuters)

Pharma & Biotech

Novartis to pay up to $2 billion for US biotech firm Excellergy (Reuters)
Sanofi reports underwhelming Phase 3 OX40 data in eczema, second case of Kaposi’s sarcoma (Endpoints)
Merck leans toward lower Winrevair dose for pivotal trial in rare form of heart failure (Endpoints)
Biogen declares Phase 2 lupus success for anti-BDCA2 antibody (Endpoints)
Exclusive: Tanabe’s Phase 3 win for drug targeting rare diseases that cause pain upon light exposure (Endpoints)
Otsuka acquires private neuropsych biotech Transcend for $700M upfront (Endpoints)
Viridian's thyroid eye disease drug succeeds in late‑stage trial but falls short of expectations (Reuters)
Incyte's skin disease drug shows long-term symptom relief in late-stage trials (Reuters)
AstraZeneca drug reduces flare-ups of chronic lung disease in late-stage trial (Reuters)

Medtech

Medtronic gets US FDA nod to use surgical system in cranial, ENT surgeries (Reuters)
FDA Finalizes Guidance On Including Patient Preference Information In Device Submissions (MedTech Insight)
Stryker restores most manufacturing after cyberattack (MedTech Dive)
Glucotrack plans US trial of implantable glucose monitor this year (MedTech Dive)
Philips wins FDA clearance for imaging device developed with Edwards (MedTech Dive)
Cancer Biomarker Test Advertising Largely OK, NAD Says (MedTech Insight)
Algorithm Outperforms Human Glucose Monitoring In T2D Study (MedTech Insight)

Food & Nutrition

Amid focus on food, FDA leader briefs lawmakers on priorities (STAT)
Researchers identify top causes of foodborne illnesses (Food Safety News)

Government, Regulatory & Legal

‘We’re on the inside now’: Meet the man building a political empire behind RFK Jr. (STAT)
7 big challenges for the next CDC director (STAT)
Washington is on the verge of true PBM reform (STAT)
Health care jobs growth is stagnating at the biggest for-profit firms (STAT)
NIH restrictions on foreign research partnerships significantly impacted 1 in 4 U.S. scientists (STAT)
Hospital Employee Controlled Substance Diversion Is a Topic at Upcoming IAHSS Conference (FDA Law Blog)

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.