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)
- 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)
- 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)
- 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 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)
- 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)
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