Recon: FDA approves J&J’s, Legend’s Carvykti for treating second-line multiple myeloma; FDA rejects Supernus’ Parkinson’s disease combo yet again

• FDA agrees to review a rare disease drug that its developer was about to give up on (STAT)
• FDA approves J&J and Legend’s Carvykti for second-line multiple myeloma (Endpoints)
• FDA grants Enhertu tumor-agnostic accelerated approval (Endpoints)
• US FDA declines to approve Supernus' Parkinson's combination again (Reuters)
• HCA reports almost $1 billion more in charity care to Medicare than to its shareholders, drawing more taxpayer money (STAT)
• The time has come for over-the-counter antidepressants (STAT)
• About half of cancer drugs given accelerated approval don’t show improved survival or quality of life (STAT)

• EU regulator to review reports of suicidal thoughts and weight loss drugs (Reuters)
• WHO scientists question Grail’s plan for evaluating its multi-cancer Galleri blood test (STAT)
• Novo Nordisk parent refiles US application on Catalent deal (Reuters)
• Catalent had several suitors, including another of its business partners, before Novo won out (Endpoints)
• Sanofi to cut jobs in pipeline restructuring (Endpoints)
• EU Health Experts On How ‘Optimization’ Could Improve Benefit Of New Cancer Drugs (Pink Sheet)
• Model Contract To Expedite UK Clinical Trial Negotiations Between Non-Commercial Sponsors & Companies (Pink Sheet)

• How resurrecting extinct species might impact medicine (STAT)
• Large trial challenges common practice of prescribing beta blockers after heart attack (STAT)
• Merck signs small acquisition to make ADCs safer (Endpoints)
• Medicxi backs Chinese biotech's next-gen KRAS G12C drug with $40M injection (Endpoints)
• Alnylam’s RNAi therapy passes second Phase 2 hypertension test, with third underway: #ACC24 (Endpoints)
• Ionis presents pivotal rare disease data, builds toward first solo launch: #ACC24 (Endpoints)
• Bristol Myers touts long-term efficacy of recently acquired Karuna drug (Endpoints)
• US-China tensions persist; Genmab's $1.8B ADC bet; New obesity startup in town; ALS drug withdrawal; and more (Endpoints)
• Arrowhead reports full Phase 2b data for lipid drug, but Ionis is a step ahead: #ACC24 (Endpoints)
• Geneos cancer vaccine shrinks liver tumors in small trial (Reuters)
• Docs sing praises of Madrigal's Rezdiffra, predict rapid uptake (Fierce Pharma)
• Cloudbreak clears up truth of pterygium symptoms, treatment in survey of eye disease med trial volunteers (Fierce Pharma)

• In first big randomized trial, Abiomed’s heart pump reduced deaths in heart attack patients (STAT)
• Patient with transplanted pig kidney had a ‘tense’ rejection episode before leaving the hospital (STAT)
• Synchron, a rival to Musk’s Neuralink, readies large-scale brain implant trial (Reuters)
• Medtronic beats Edwards on valve dysfunction in TAVR study (MedTech Dive)
• Medtronic survey finds older women face gap in awareness of and screening for aortic stenosis (Fierce Pharma)
• J&J to acquire Shockwave Medical for $13.1B (MedTech Dive)
• Freenome’s colorectal cancer blood test data underwhelm analysts (MedTech Dive)

• OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts (FDA Law Blog)
• Quick And Flexible Vaccine Approval Must Include Postmarket Simplicity, US FDA’s Kaslow Says (Pink Sheet)
• Biosimilar Substitution In Medicare Part D Formularies Mid-Year Established In Final Rule (Pink Sheet)
• Abecma Approval In Earlier Myeloma Carries Caution On Early Death Data (Pink Sheet)