Recon: Pfizer wins RSV vaccine patent fight; Baxter uncertain when hurricane-hit plant will reopen

• 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)