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December 10, 2024
by Jason Scott

Recon: Lilly plans to test weight-loss drugs for alcohol, drug addiction; PhRMA not lobbying against RFK Jr. nomination

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Budget negotiations heat up as ACA subsidy extension, BIOSECURE get dropped (STAT)
  • The pharma industry isn’t lobbying against RFK Jr.’s nomination for a top health role (STAT)
  • Walgreens in talks to sell itself to PE firm Sycamore, WSJ reports (Reuters)
  • Cases of severe RSV in two Moderna vaccine candidates' trials raise questions about future (Endpoints)
  • Lilly CEO says tax and regulation reform, drug affordability are focuses under Trump (Reuters)
  • Eli Lilly to test obesity medications as treatments for alcohol and drug addiction, CEO says (STAT)
  • High-flying Eli Lilly plots $15B share buyback plan (Fierce Pharma)
In Focus: International                                                                                                       
  • WHO's Tedros confident of finalising pandemic treaty in 2025 (Reuters)
  • BioNTech reports early survival data for VEGF bispecific, weeks after buying Chinese partner (Endpoints)
  • Inertia For Supply Chain Change May Stick Even If BIOSECURE Fails (Pink Sheet)
  • EU HTA-Co-ordination Group Prepares For New Wave Of Joint Clinical Assessments In 2025 (Pink Sheet)
  • Tackling Mpox: Global Regulators Call For Larger Trials And Coordinated Pathways (Pink Sheet)
  • Japan Recommends Approval Of Dato-DXd, Sipavibart (Pink Sheet)
  • BioMarin to add €60M lab to Irish manufacturing site in push to grow production capacity (Fierce Pharma)
  • Record dengue outbreak in Americas kills 7,700 this year, PAHO says (Reuters)
Pharma & Biotech
  • Stem cell transplant not needed for most mantle cell lymphoma patients, study suggests (STAT)
  • Young biotech venture firm raises $500 million for its second fund (STAT)
  • Uniqure gets FDA OK to seek accelerated approval (STAT)
  • Do GLP-1s work for Parkinson’s? A health tech startup pitches pharma on quick answers (STAT)
  • Johnson & Johnson seeks first drug approval for treatment of smoldering myeloma (STAT)
  • Siga's mpox drug did not improve lesion resolution or pain, NIH study finds (Reuters)
  • CervoMed's dementia drug fails mid-stage trial, shares slump (Reuters)
  • Zealand Pharma starts Phase 2b trial for obesity drug candidate petrelintide (Reuters)
  • Spruce Biosciences to wind down investment for genetic disorder drug (Reuters)
  • GSK's drug combo shown to cut risk of death by 42% in type of blood cancer (Reuters)
  • Roche initially didn't want to buy Poseida — and partner Astellas didn't submit an offer, new filings show (Endpoints)
  • New oncology biotech launches with $52M in its pocket (Endpoints)
  • Cardiff unveils positive Phase 2 data for colorectal cancer drug, $40M offering (Endpoints)
  • Halia Therapeutics takes NLRP3 inhibitor into final stage of Phase 2 trial (Endpoints)
  • Early data suggest Arvinas, Pfizer could combine their breast cancer drug with Lilly’s Verzenio (Endpoints)
Medtech
  • How Trump’s second term will affect the medtech industry (MedTech Dive)
  • Vicarious Surgical CFO William Kelly stepping down in January (MedTech Dive)
  • Intuitive’s da Vinci beats non-robotic surgeries in cancer meta-analysis (MedTech Dive)
  • AI-enabled apps top ECRI’s list of health tech hazards in 2025 (MedTech Dive)
  • PharmStars’ Founder Aims To Bridge ‘Pharma Start-Up Gap’; Alumni Are Ready To Pounce On Pharma Deal (MedTech Insight)
Government, Regulatory & Legal
  • Police arrest suspect in killing of UnitedHealthcare CEO Brian Thompson (STAT)
  • Jamie Foxx calls on the Senate to pass a bill funding Down syndrome research (STAT)
  • Researchers are betting on cockroaches as the cure to elitism in neuroscience (STAT)
  • Pharmacies prevail in appeal of $650-million opioid award in Ohio (Reuters)
  • HPM and Riparian to Co-Host Webinar on CMS Misclassification Penalties Rule (FDA Law Blog
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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