Recon: GLP-1 price war continues; Do AI device regs miss the human element?

In Focus: US

• Proposed FDA budget aligns Makary, Trump behind rivaling China biotech (Endpoints)
• FDA lays out policy wish list, including new trial pathway and new enforcement powers (Fierce Pharma)
• FDA backs proposals to entice pharma companies to test, make drugs domestically (STAT)
• FDA seeks legislative teeth to bite back against misleading DTC drug ads (Fierce Pharma)
• Novo Undercuts Lilly With High-Dose Wegovy at $399 a Month (Bloomberg)
• Exclusive: US upends global supply program for malaria and HIV amid warnings of gaps (Reuters)

In Focus: International

• BioNTech to shutter Singapore HQ after 'comprehensive review' (Endpoints)
• J&J launches enhanced PFA device in Europe (MedTech Dive)
• MHRA Wants To Keep US FDA Close, And EU Closer (MedTech Insight)
• With Gardasil demand shortfall in China, Merck and Zhifei adjust their partnership (Fierce Pharma)

Pharma & Biotech

• Merck’s experimental HIV prevention pill could be made for less than $5 a year, researchers say (STAT)
• How a four-month FDA delay forced a small biotech company to close its doors (STAT)
• Merck got a peek at Terns' leukemia data during its deal talks — and decided to lower its bid by $1B (Endpoints)
• Sanofi bispecific sails through asthma, sinusitis trials, but disappoints in eczema (Endpoints)
• Vertex taps Halozyme and its recently acquired Elektrofi tech in $15M drug delivery deal (Fierce Pharma)
• Gilead to buy cancer biotech Tubulis for more than $3 billion (STAT)

Medtech

• Many cancer patients don’t get genomic tests to guide treatment, study finds (STAT)
• Zimmer hires chief science, technology and medical affairs officer (MedTech Dive)
• VDyne secures FDA nod to start pivotal trial for tricuspid valve (MedTech Dive)
• Are AI Device Regulations Forgetting The Human Factor? (MedTech Insight)
• BCI Maker Epia Neuro Bets On ‘Intent-Driven’ Rehab For Stroke Patients With Implant, Glove (MedTech Insight)
• Philips Recalls Thousands Of X-Ray Systems Due To ‘Device Design’ Malfunction (MedTech Insight)

Food & Nutrition

• Swiss study finds E. coli, Yersinia and Listeria in raw milk (Food Safety News)
• FDA withholds company names in report on mango outbreak (Food Safety News)

Government, Regulatory & Legal

• ARPA-H selects three academic teams in $100M effort to repair and regrow ailing joints (Endpoints)

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.