Recon: Lilly to acquire Kelonia for up to $7B; Trump issues order to speed psychedelic drug access

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

In Focus: US

How Trump is pushing psychedelics reform through the health agencies (STAT)
A controversy over research monkeys highlights ambiguity over health standards (STAT)
PBMs warn Trump’s proposal to disclose drug prices is illegal (STAT)
Cheap Weight-Loss Drugs Are Great — When They're Legal (Bloomberg)
After Layoffs, HHS Plans 12,000 New Hires Aligned With Trump Administration Priorities (Pink Sheet)

In Focus: International

Biogen buys China rights to immune disease drug in up to $850 million deal with TJ Biopharma (Reuters)
Boehringer Ingelheim launches AI centre for pharma research in London (Reuters)
South Korea Targets Syringe Hoarding as War Rattles Supply (Reuters)
EU Pharma Reform Supply Obligations ‘Burdensome’ For SMEs, Warns EUCOPE (Pink Sheet)
India’s Trademark Regime: Regulatory Blind Spot, Patient Safety And Case Laws To Heed (Pink Sheet)

Pharma & Biotech

Lilly to buy Kelonia Therapeutics for up to $7 billion to boost cancer pipeline (Reuters)
Extended use of Nektar Therapeutics drug shows promise in alopecia (STAT)
The race to catch KRAS, pancreatic cancer’s ‘greasy ball,’ and create the most promising drug in decades (STAT)
US figures suggest HIV aid was maintained; but data show drops in testing, diagnoses (Reuters)
Gilead declines another Arcus option after Phase 3 TIGIT fail (Endpoints)
Updated: Novo Nordisk’s sickle cell therapy hits in Phase 3, but data lag expectations (Endpoints)
UCB plots epilepsy expansion with $650M Neurona cell therapy acquisition (Endpoints)
Odyssey Therapeutics will try again to IPO, this time in a warmer market (Endpoints)
Three gene therapy pioneers just won the Breakthrough Prize. This is their story (Endpoints)
Obesity Drugmaker Kailera Soars 63% After $625 Million IPO (Bloomberg)

Medtech

McKesson sells minority stake in surgical supplies unit to Apollo Funds for $1.25 billion (Reuters)
Biotech Odyssey, Medical Device Firm Mobia File for US IPOs (Bloomberg)
Medical Device Maker Alamar Bio Jumps 29% After Upsized IPO (Bloomberg)
Medtronic closes $585M purchase of CathWorks (MedTech Dive)
Siemens plans shareholder vote on Siemens Healthineers spinoff (MedTech Dive)
Philips secures FDA clearance for AI-enabled CT system (MedTech Dive)
GE HealthCare, RadNet expand AI mammography collaboration (MedTech Dive)
CMS proposes repeal of add-on payment path for breakthrough devices (MedTech Dive)
Harbinger Raises $100M, Presents New Data For Cancer Tests At AACR (MedTech Insight)
Medtronic, Pulnovo Join Forces On Pulmonary Denervation After $100M Financing (MedTech Insight)

Food & Nutrition

Rat poison found in HiPP baby food jar in Austria, police say (Reuters)
Food waste began to decline 4 years after the pandemic, Refed finds (Food Dive)

Government, Regulatory & Legal

Politicians are using low teen birth rates to further restrict access to birth control, abortion (STAT)
Measles outbreak means my immunocompromised son can’t leave the house without extreme safety measures (STAT)
As Measles Takes Toll on Kids, Anti-Vaxxers Have Change of Heart (Bloomberg)
US judge rejects Bayer bid to block Johnson & Johnson prostate cancer drug claims (Reuters)
UnitedHealth Isn’t Out of the Woods With $6 Billion Medicare Hit (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.