Recon: FDA declines to approve Eli Lilly eczema therapy over issues with contract manufacturer; Japan’s PMDA plans US office

• Court allows Medicare drug price negotiation to proceed (STAT)
• Sales from controversial drug discount program rose to $54 billion last year (STAT)
• CDC proposes new antibiotics policy aimed at reducing STIs (STAT)
• Novo Nordisk Files Lawsuit Challenging Medicare Drug Price Talks (Bloomberg Law)
• Walgreens Eyes Tim Wentworth, Ex-Cigna Executive, for CEO (Bloomberg)
• UPDATE 3-U.S. FDA declines to approve Eli Lilly's drug to treat eczema (Reuters)
• Biden administration looking to expand coverage of OTC birth control, other products (The Hill)

• J&J agrees not to enforce patents on a key tuberculosis drug in dozens of poor countries (STAT)
• Generic makers fall short when providing access to low- and middle-income countries, analysis finds (STAT)
• Japan’s Drug Agency Seeks US Office with Eye on Washington to Help Japanese Obtain New Effective Treatments (The Japan News)
• EU Regulatory Roundup, September 2023: Dismantling Regulatory Barriers To Medtech Innovation (MedTech Insight)

• Drugmaker Viatris to divest some businesses for $3.6 bln (Reuters)
• Biogen claims first with FDA nod for biosimilar Actemra (Pharmaphorum)
• US FDA approves Novo Nordisk's therapy for rare genetic condition (Reuters)
• Novartis to seek accelerated approval for oral complement inhibitor in rare kidney disease (Endpoints)
• 2023 Nobel Prize in Medicine: Karikó, Weissman awarded prize for mRNA research (STAT)
• Here’s what’s moving the needle in biotech stocks, in the final quarter of a dismal year (STAT)
• Q3 snapshot: The IPO market shows fresh signs of improvement, but the biotech crunch continues to bite (Endpoints)
• Syndax’s leukemia drug succeeds in pivotal study (STAT)
• Mirum’s Chenodal succeeds in late-stage trial for rare metabolic disorder (STAT)
• What we owe ALS patients — and why one company fell short (STAT)
• Can the world still invent an HIV vaccine? Progress in one area creates new problem (STAT)
• Rocket’s gene therapy gets a PDUFA date; SAB Biotherapeutics’ $130M; Acurix to move to PhIII (Endpoints)
• Syros lays off 35% of workers, replaces CEO and loses CSO after axed pacts (Endpoints)
• Exclusive: Dimension leads $40M round for lab automation company Automata Technologies (Endpoints)
• Infinity Pharmaceuticals files for bankruptcy after layoffs, scrapped merger with MEI Pharma (Endpoints)

• US Supreme Court rebuffs CareDx patent lawsuit over organ-rejection tests (Reuters)
• Exclusive: Providence just launched a startup for one of hospitals’ biggest problems — maintaining patient relationships (Endpoints)
• Exclusive: Carlyle in exclusive talks for $7 billion-plus Medtronic units deal (Reuters)
• Accuray’s Suzanne Winter to lead AdvaMed radiotherapy sector (MedTech Dive)
• Mayo Clinic partner earns 510(k) clearance for heart failure screening algorithm (MedTech Dive)
• Friend, not foe: How AI will revolutionize patient care (MedTech Dive)
• Abbott data suggests GLP-1 drugs a ‘modest accelerator’ for CGMs: analysts (MedTech Dive)

• Former FDA official lays out how to keep patients safe from risky medical devices (STAT)
• Cigna to pay $172 million in Medicare Advantage fraud settlement (STAT)