Recon: UK picks Pfizer to supply RSV vaccine jabs; Alnylam touts positive Phase 3 results for heart drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Project Optimus: Sponsors Register Concerns, Questions (Pink Sheet)
- Lykos’ pain is others’ gain as psychedelic biotechs take notes from adcomm vote (Endpoints)
- Déjà Vu: CBER Director’s Intervention Saves Sarepta’s Elevidys Again (Pink Sheet)
- News We’re Watching: Boston Sci Buys Silk Road Medical; EOFlow Injunction Blocked; LDT Compliance Dates Announced (MedTech Insight)
- Appeals court does not block US mandate to cover cancer screenings, HIV drugs (Reuters)
- Steward Health Care executives are mired in trouble at home. In Malta, it’s much worse (STAT)
- UK taps Pfizer over hometown GSK to supply RSV vaccine doses (Endpoints)
- EU RWE Projects Show The ‘Data Revolution In Health Research' Is Here (Pink Sheet)
- Council Of EU Aligned With Parliament Over Need For Future MDR Amendments (MedTech Insight)
- UK NHS, Industry Agreement On Artificial Pancreas Pricing Clears Way For Takeoff (MedTech Insight)
- Alnylam reports positive results for heart drug in pivotal study, likely clearing path to approval (STAT)
- Commercial-stage blood cancer biotech files for US dual listing (Endpoints)
- Schizophrenia biotech LB Pharmaceuticals eyes near-term IPO filing — source (Endpoints)
- Amylyx, searching for post-ALS future, licenses a GLP-1 drug (Endpoints)
- Alumis aims for this year’s third-largest biotech IPO as it readies for Phase 3 (Endpoints)
- ‘Is This Doomsday Concern, Or Is It Reality?’ Verily CMO On AI’s Future, Lightpath Metabolic, More (MedTech Insight)
- A biotech’s binary bet ends badly (STAT)
Medtech
- Orthofix’s president of global orthopedics resigns (MedTech Dive)
- Tandem names Jean-Claude Kyrillos as chief operating officer (MedTech Dive)
- Philips Respironics to end manufacturing at two Pennsylvania plants: report (MedTech Dive)
- J&J creates open digital platform for surgical applications (MedTech Dive)
- ONC’s Micky Tripathi on laying the digital floor for healthcare AI (MedTech Dive)
- Former Stimwave CEO gets 6 years in prison for fake device scheme (MedTech Dive)
- Q&A: How Kaiser Permanente tracks and weeds out risky medical devices (STAT)
Government, Regulatory & Legal
- The FDA needs to embrace phage therapy to help fight antimicrobial resistance (STAT)
- Ateev Mehrotra, the researcher the telehealth lobby loves to hate, isn’t backing down (STAT)
- Bird flu snapshot: USDA secretary urges farmers to take protective measures (STAT)
- Two years since Dobbs, reproductive freedom must be protected from assault (STAT)
- FDA Finalizes Definitions Of Delaying Or Denying Inspections (MedTech Insight)
- Doctor's recommendation does not bar patient's lawsuit over device -California top court (Reuters)
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.
