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April 15, 2025
by Jason Scott

Recon: EC authorizes Eisai, Biogen Alzheimer’s drug for early treatment; CDC advisers begin review of vaccine guidelines

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

In Focus: US
  • Attorneys general want Congress to prohibit PBMs from owning affiliated pharmacies (STAT)
  • At Harvard, scientists worry over the consequences of resisting the Trump administration: $2.2B in grants frozen (STAT)
  • US steps up probes into pharmaceutical, chip imports, setting stage for tariffs (Reuters)
  • US CDC advisers begin review of vaccine guidelines after months-long delay (Reuters)
  • Transcript: Dr. Peter Marks on "Face the Nation with Margaret Brennan," April 13, 2025 (CBS)
  • Johnson & Johnson CEO warns US tariffs may disrupt drug supply (Reuters)
In Focus: International
  • Canada advances an antitrust probe into Express Scripts over ‘patient steering’ and pharmacy fees (STAT)
  • European pharma companies issue demands to stay in EU ahead of expected US tariffs (Reuters)
  • Tariff wars to hit popular US-made drugs in China, regulator data shows (Reuters)
  • GSK in breach for misleading prescription information on Omjjara, industry body says (Reuters)
  • China's Duality Biotherapeutics shares rise more than double in Hong Kong debut (Reuters)
  • EU authorizes Eisai-Biogen's drug for early Alzheimer's treatment (Reuters)
Pharma & Biotech
  • Doctors remove pig kidney from an Alabama woman after a record 130 days (STAT)
  • How a downturn in biotech may be felt in Kendall Square, an industry hub (STAT)
  • Sanofi’s Kymab-originated inflammatory drug flunks mid-stage asthma trial (Endpoints)
  • Mural Oncology ends clinical development, lays off most workers (Endpoints)
  • Attovia collects another $90M for I&I biologics in third funding round in two years (Endpoints)
  • Exclusive: A small biotech will bring Roche's Angelman drug back to life (Endpoints)
  • J&J, pharma's earnings bellwether, maintains guidance as tariffs loom (Endpoints)
  • Merck explores potential of oral peptides in deal with Austrian biotech (Endpoints)
  • Siddhartha Mukherjee’s cell therapy startup narrows focus as staff shrinks (Endpoints)
  • Boehringer's bispecific pact with Cue Biopharma; HepaRegeniX raises €21.5M (Endpoints)
Medtech
  • Tariffs top of mind for medtech firms this earnings season (MedTech Dive)
  • Late-stage digital health funding rebounds in Q1: Rock Health (MedTech Dive)
  • Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark (MedTech Insight)
  • MedStar Teams Up With Reimagine Care To Extend Cancer Care Into Patients’ Home (MedTech Insight)
  • Dexcom Promotes CGM As First-Line Tool In Type 2 Diabetes (MedTech Insight)
  • Gleamer Charts Multi-Modality Future With FDA Nod And MRI Acquisitions (MedTech Insight)
  • Unlocking Potential: Could EU’s New Surgical Centers Drive Demand For Advanced Medtech? (MedTech Insight)
Food & Nutrition
  • Food manufacturers rethink innovation to keep up with rapidly-changing consumer demands (Food Dive)
  • Lab-Confirmed Cases of Salmonella, Campylobacter Infections in England Increased in 2023 (Food Safety)
  • USDA-FSIS Delays Salmonella Verification Sampling of NRTE Breaded, Stuffed Chicken Products by Six Months (Food Safety)
Government, Regulatory & Legal
  • Fired FDA communications staff worry about impact on public health (Roll Call)
  • The NIH called my health equity research ‘antithetical to scientific inquiry’ (STAT)
  • US House committee seeks testimony from 23andMe co-founder after bankruptcy (Reuters)
  • An interview with Christi Grimm, and ‘existential’ upheaval at HHS (STAT)
  • Universities begin search for indirect-cost fix that might assuage Trump administration (STAT)
  • ASCA 2024 Performance Update: Can ASCA Improve Submission Predictability? (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.
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