Recon: Eisai’s injectable version of Alzheimer’s drug Leqembi as effective as infusion; J&J weighs bankruptcy as it faces baby powder suits

• Pfizer’s Pentavalent Meningococcal Vaccine Gets CDC Cmte. Recommendation For Off-Label Use (Pink Sheet)
• Insulin Costs Remain Top Target Beyond Biden’s Drug Price Cuts (Bloomberg Law)
• Advocacy groups call on Congress to reauthorize global HIV initiative (The Hill)
• Pfizer’s twice daily pill for obesity hopes to rival Wegovy and Mounjaro (STAT)
• Looking to retain billions, hospitals warn Medicare’s drug payment fix is ‘unlawful’ (STAT)
• NIH nominee Monica Bertagnolli clears Senate panel with bipartisan support despite Sanders’ drug pricing qualms (Endpoints)
• US CDC recommends routine use of Bavarian Nordic mpox vaccine for adults at risk (Reuters)

• Europe takes steps to head off drug shortages, even as U.S. proposals stall (STAT)
• International Regulators Say Collaboration Is Key To Tackling Pharma Globalization Challenges (Pink Sheet)
• EMA Explains Modeling Approaches To Predicting PK In Neonates (Pink Sheet)
• Europe’s Sofinnova raises first $200M digital medicine fund, looking to back over 15 startups (Endpoints)
• EuroAPI CEO steps down; Samsung Biologics looks to Europe; Merck recalls pneumococcal vaccines (Endpoints)

• Under-the-skin injection of Eisai’s Leqembi is as effective as IV infusion, new Alzheimer’s data show (STAT)
• Biogen’s tau-lowering drug slows cognitive decline in early study of Alzheimer’s disease (STAT)
• When treating Alzheimer’s, earlier is better, according to analysis of Lilly and Eisai trials (Endpoints)
• Pfizer, BioNtech say flu-COVID shot generates strong immune response in trial (Reuters)
• Novartis claims Takeda is stonewalling efforts to review trade secrets taken by a former employee (STAT)
• Takeda takes $770M writedown on failed stem cell therapy and withdrawn cancer drug (Endpoints)
• ManaT Bio, a KRAS biotech from Bert Vogelstein and Catalio, targets $153M with Third Rock partner as CEO (Endpoints)
• Triveni Bio launches with $92M Series A to fund eczema antibody treatment (Endpoints)
• Zocdoc’s CEO shares how the 16-year-old company weathered Covid-19, and why some startup ideas fail (Endpoints)
• GSK's common respiratory virus vaccine shows potential in adults aged 50-59 (Reuters)
• Merck quarterly profit tops expectations on COVID pill surprise (Reuters)
• Bristol Myers says it needs another year to hit target for new drugs (Reuters)

• Take Steps Now To Comply With IVDR Now Or Face The Consequences, Industry Told (MedTech Insight
• Abbott to cease sale of infant probiotic products after FDA warning (Reuters)
• Labcorp beats quarterly profit estimates on strength in routine testing segment (Reuters)
• Boston Scientific looks to new devices in 2024 to drive growth (MedTech Dive)
• Boston Scientific lifts earnings forecast on solid demand for heart devices (Reuters)
• Edwards reported double-digit Q3 sales growth, but some analysts are skeptical about 2024 (MedTech Dive)
• Abbott’s resorbable scaffold improves outcomes in below-the-knee artery disease, study finds (MedTech Dive)
• Thermo Fisher grows into CGT manufacturing, while Samsung Biologics expands into ADCs (Endpoints)
• Thermo Fisher cuts 2023 forecast, citing volatile economic conditions (MedTech Dive)
• Edwards, Medtronic post low-risk TAVR data, allaying fears of market disruption (MedTech Dive)
• Icahn’t Believe It Isn’t Over: Investor Sues Illumina (MedTech Insight)
• Digital Health Roundup: HLTH, LSX, AdvaMed; FDA And Pre-Determined Change Control Plans (MedTech Insight)

• J&J Faces 18 Talc-Cancer Trials as It Weighs Bankruptcy (Bloomberg)
• Oncologists more likely to provide low-value care after receiving pharma money, study finds (STAT)
• ‘We’re absolutely making it too hard’: The complexity of adult immunization delivery hinders vaccine uptake (STAT)
• Trade Commission Finds Mixed Effects From Patents In COVID-19 Fight (MedTech Insight)