Recon: Pfizer wins RSV vaccine patent fight; Baxter uncertain when hurricane-hit plant will reopen
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Janet Woodcock, former FDA official, joins board of patient group focused on ‘rediscovering’ old drugs (STAT)
- 2024 Nobel prize in medicine: Ruvkun, Ambros win for discovery of microRNA (STAT)
- After a rocky debut for new RSV tools, hopes are high as a new season approaches (STAT)
- Pfizer targeted by activist, following post-pandemic stumbles — reports (Endpoints)
- Pfizer wins bid to invalidate GSK's patents over RSV vaccine (Reuters)
- 12 people changing the course of the Chinese biopharma industry (STAT)
- Rwanda to receive experimental vaccines, therapeutics to combat Marburg outbreak (STAT)
- AstraZeneca makes another cardio deal, betting $100M on China company’s lipid drug (Endpoints)
- AstraZeneca signs $1.92 bln licencing deal with HK-listed CSPC (Reuters)
- EU Launches Safety Review Of Finasteride & Dutasteride Over Suicidal Thoughts & Behavior (Pink Sheet)
- Singapore Releases eCTD Specification Package As Companies Prepare For Portal Launch (Pink Sheet)
- EMA Clarifies Quality & Equivalence Testing Expectations For Cutaneous Products (Pink Sheet)
- Japan Patients To Pay Part Of Price Difference When Insisting On Branded Drugs (Pink Sheet)
- Scholar Rock drug for spinal muscular atrophy succeeds in late-stage study (STAT)
- Galapagos investor gets board seat; OnKure completes merger with Reneo (Endpoints)
- Oaktree creates third life sciences SPAC, following success with Hims & Hers and Alvotech (Endpoints)
- Judo Bio launches with $100M for kidney-targeted siRNA therapies (Endpoints)
- Exact Sciences wins FDA approval for improved stool-based colon cancer test (STAT)
- Opinion: The Only Thing That’s Permanent in Life Is Change (Medtech Insight)
- Medtronic recalls Minimed insulin pumps for reduced battery life (MedTech Dive)
- MHRA Promises UK Devices Regulation Will Enter ‘New Era Of Evolution’ (Medtech Insight)
- Smiths recalls ventilators over risk of oxygen flow disruption (MedTech Dive)
- Baxter unsure when North Carolina facility hit by Hurricane Helene will be operational (MedTech Dive)
- Elucid wins FDA 510(k) nod for heart plaque image analysis software (MedTech Dive)
- Q&A: AI is coming for lots of jobs. What about that of the cancer researcher? (STAT)
- 340B Rebate Dispute: HRSA Threat To Bar J&J From Medicare Part B, Medicaid ‘Unprecedented’ (Pink Sheet)
- Prior Authorization Reform: 2025 Could Be A Year Of Changes (Pink Sheet)
- US FDA’s New Voucher Fee Reveals Standard, Priority Review Cost Spike (Pink Sheet)
- First Constitutional Challenge to FDA’s Civil Money Penalty Authority (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.
