Recon: Pharma companies urge Trump administration to protect China deals; EU drugmakers seek faster trials, more spending to compete with US, China
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Members of Congress push back on plan to create a commission of political appointees to review NIH grants (STAT)
- Psychedelic REMS framework must start with data standardization, stakeholders tell FDA (Pink Sheet)
- Pfizer, Lilly 'most favored nation' deals to give US share of revenue from raised foreign prices (Endpoints)
- A federal AI experiment could transform chronic care — if doctors and patients want it (Endpoints)
- Pfizer CEO Bourla plans to attend White House state dinner for China's Xi, source says (Reuters)
In Focus: International
- European drugmakers call for faster trials, more spending to compete with US, China (Reuters)
- Pharmaceutical companies push Trump administration to protect China deals (Wall Street Journal)
- Pharma bosses warn European leaders future investment at risk (Bloomberg) (Reuters)
- Same QPPV obligations, different realities across pharma companies (Pink Sheet)
- EU cloud and AI development act: Pharma industry seeks exemptions (Pink Sheet)
- Study says GLP-1 apps can improve adherence, as UK addresses ‘evidence gaps’ (Medtech Insight)
Pharma & Biotech
- Boehringer, Envisagenics sign $1B multi-target oncology collaboration (Fierce Biotech)
- Mayo Clinic, Thermo Fisher partner to create Precure (MedTech Dive)
- Roche says Carmot-acquired shot delivers phase 2 win in overweight patients with diabetes (Endpoints) (Reuters)
- Amgen's autoimmune drug succeeds in late-stage trial (Reuters)
- Celldex's skin disease drug meets goals in two late-stage trials (Reuters)
- Otsuka, Ionis' experimental ALS drug meets main goal in late-stage study (Reuters)
- Viking Therapeutics' obesity drug shows durable weight-loss benefit, shares jump (Reuters)
- Novo offers low-dose CagriSema data as approval decision looms (Endpoints)
- Iambic releases next version of its Enchant model, signs deal with AbbVie (Endpoints) (Reuters)
- Novo Nordisk and UNICEF renew push to prevent childhood obesity (Reuters)
Medtech
- Medtronic wins FDA clearance for LigaSure instrument for Hugo surgical robot (Medtech Insight)
- Withings adds AI heart and lung analysis to FDA-cleared BeamO home health device (Medtech Insight)
- Dialybrid closes €15m Series A as Silkothane graft enters vascular access race (Medtech Insight)
Food & Nutrition
- UK FSA board decides to advance sweeping food system regulatory reforms (Food Safety Magazine)
- E. coli outbreak tied to frozen berries sold at Walmart and Publix has ended (Food Safety News)
- Swedish analysis reveals scale of unreported foodborne infections (Food Safety News)
- Hepatitis A outbreak traced to clams continues (Food Safety News)
Government & Legal
- Pentagon defends designating WuXi AppTec as Chinese military company (Endpoints)
- Trump’s largely redacted drug pricing deal docs include a decade of undisclosed terms (Pink Sheet)
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.
