Recon: Amgen sues Samsung Bioepis over bone drug biosimilars; Carlyle to buy Baxter’s kidney care unit for $3.8B

• Amgen sues Samsung biotech unit over bone drug copies (Reuters)
• Biden targets tumors with $150 mln funding for 'Cancer Moonshot' program (Reuters)
• Lawmakers renew calls for government to finalize march-in guidance (Endpoints)
• Pressure from anti-China legislation begins to ripple through biopharma (Endpoints)
• Carlyle to buy Baxter's kidney-care spinoff Vantive for $3.8 billion (Reuters)
• Novartis loses initial bid to block generic of best-selling heart drug (Reuters)
• Current, Former US FDA Adcomm Members' Reform Idea: Allow Conflicted Experts To Participate (Pink Sheet)
• The politics of mifepristone in the 2024 election (STAT)
• Atai advances oral psychedelic in depression (STAT)

• Amgen announces plans for new site in India to strengthen AI, data and life sciences (Endpoints)
• Africa public health body declares mpox emergency (Reuters)
• WHO Invites Vaccine Manufacturers to Join Fight Against Growing Mpox Outbreak (Pink Sheet)
• EMA Considers Changing Scientific Advice Briefing Doc To Enhance Patient Input (Pink Sheet)
• EMA’s PRIME Sees New Targets, More Approvals But Few Fast-Track Reviews (Pink Sheet)

• Mark Cuban's Cost Plus to import penicillin to address US shortage (Reuters)
• Halda adds $126M to test oral drugs for prostate, breast cancer (Endpoints)
• CSL Behring says uptake of hemophilia B gene therapy slower than expected (Endpoints)
• After icodec rejection, Novo Nordisk won't file application for once-weekly insulin and semaglutide combo in US (Fierce Pharma)
• Exclusive: Gates Foundation backs startup using optogenetics to manufacture biologics (Endpoints)
• Kyverna shares safety data for CAR-T; Evotec gets $75M milestone (Endpoints)
• Legend continues Carvykti factory builds to cement CAR-T territory with J&J (Endpoints)
• Galderma wins FDA approval for IL-31 drug in chronic skin disease (Endpoints)
• Revance to be acquired for $900M+ as Botox trade secrets lawsuit continues (Endpoints)
• At least half of doctors and patients find DTC pharma ads helpful: report (Fierce Pharma)

• Illumina, CRISPR-pioneer Broad Institute to work on new gene sequencing kits (Reuters)
• How UnitedHealth turned a questionable artery-screening program into a gold mine (STAT)
• Otsuka prices depression digital therapeutic to make it widely accessible, says it’ll lose money (STAT)
• Why a new health tech venture firm is investing only in founders with a healthcare background (Endpoints)
• Advances In Reimbursement: Prostate Cancer AI Mapping Receives CPT Code (MedTech Insight)
• Hello Heart Says Update To Cardiovascular Health Tracker Could Benefit Women Especially (MedTech Insight)

• Controlling obesity is a noble goal. Controlling mpox is a far more urgent one (STAT)
• Why U.S. health care cybersecurity laws are better at protecting a corpse’s privacy than patients’ lives (STAT)
• Aspirin after a broken bone: health equity in a $5 bottle (STAT)
• What’s in a drink? U.S. regulators consider new alcohol label, but health advocates want even more (STAT)
• US FDA Advisory Committee Conduct Could Take Center Stage in Lykos Appeal of MDMA Rejection (Pink Sheet)
• False Claims Collections Top $1B In First Half Of Year (MedTech Insight)
• Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious (FDA Law Blog)