Recon: CDC recommends Pfizer’s maternal RSV vaccine; Medtronic earns CE mark for CGM sensor

• What ever happened to biotech’s big comeback? (STAT)
• Cancer drug shortages widen disparities between big systems and small (STAT)
• BrainStorm’s case for ALS approval relies on ‘grossly deficient’ data, FDA finds (STAT)
• US CDC backs Pfizer's maternal RSV vaccine to protect infants (Reuters)
• Scynexis to recall GSK-partnered antifungal on cross-contamination risk (Reuters)

• Japan approves Alzheimer's treatment Leqembi by Eisai and Biogen (Reuters)
• WHO releases step by step guide to help countries develop their national genomic surveillance strategy for pathogens with pandemic and epidemic potential (Pharmabiz)
• Pakistan probes distributors of Roche cancer drug after patients go blind (Reuters)
• Medtronic receives CE mark for CGM sensor, boosting challenge to Abbott and Dexcom (MedTech Dive)
• After FDA rejection, Lilly's ulcerative colitis drug Omvoh picks up support from England's NICE (Fierce Pharma)
• Products Targeting Alzheimer's, Duchenne & COVID-19 Among New EU Filings (Pink Sheet)
• Gene Therapy HTA: How Do The European, Australian And Canadian Systems Shape Up? (Pink Sheet)

• ImmunityBio lays off 50 employees in Florida and California after bladder cancer BLA rejection (Endpoints)
• AbbVie fully ditches I-Mab's CD47 drug after initial 2022 pullback from $1B+ bet (Endpoints)
• Novartis confirms Sandoz spin-off for October 4, 2023 (Reuters)
• Novartis targets first-line use for radiotherapy Lutathera after trial win in neuroendocrine tumors (Fierce Pharma)
• Novo Nordisk and Valo to research cardiometabolic treatments (Reuters)
• BridgeBio inks $250M PIPE two months after PhIII heart pill win, hints at more financing (Endpoints)
• For decades, cancer drug developers have focused on inhibition. Now, a GV-backed startup is eyeing activation (Endpoints)
• Coherus hits FDA hurdles for PD-1 drug, Neulasta biosimilar on-body injector (Fierce Pharma)

• Artificial heart maker Carmat says it will miss sales target, could run out of cash (Reuters)
• Enovis to buy surgical implants maker LimaCorporate for $850 mln (Reuters)
• Intarcia’s diabetes drug-device combo voted down again by FDA panel (MedTech Dive)
• Is bigger better? McKinsey predicts the return of large medtech mergers (MedTech Dive)
• Boston Scientific expects ‘dramatic shift’ to pulsed field ablation to fuel fast growth through 2026 (MedTech Dive)
• Hologic allies with Bayer to support uptake of contrast-enhanced mammography (MedTech Dive)
• Labcorp backs Adela’s $48M Series A1 to advance methylation-based head and neck cancer test (Endpoints)

• CPSC Decision Highlights Some Don’ts of Agency Rulemaking (FDA Law Blog)
• FDA Gene Therapy Office Chief Prefers Flexibility With Accelerated Approval Confirmatory Trials (Pink Sheet)
• Finding The Sweet Spot For Real-World Evidence: Aetion Stresses Early Feasibility Assessment (Pink Sheet)