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August 5, 2024
by Michael Mezher

Recon: Lawmakers press FDA on Lykos MDMA drug ahead of PDUFA date; FDA approves Adaptimmune’s Tecelra for rare cancer

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Lilly, Novo Nordisk battle for weight-loss market lands at the pharmacy shelf (Reuters)
  • Neuralink implanted second trial patient with brain chip, Musk says (Reuters)
  • US FDA approves Adaptimmune's therapy for rare type of cancer (Reuters)
  • US FDA says all doses of Lilly's weight-loss and diabetes drug are now available (Reuters)
  • Medicare scrambles to keep prescription drug plan premiums stable ahead of elections (STAT)
  • Psychedelic divide: Lawmakers clash with FDA (Politico)
In Focus: International
  • BioNTech counts on shift to cancer drugs after second quarter losses quadruple (Reuters)
  • India's GlaxoSmithKline Pharma posts higher Q1 adjusted profit on strong demand (Reuters)
  • Novo Nordisk spends record amounts on research to fend off weight-loss rivals (FT)
  • Third Rock and Arie Belldegrun’s firm come together for CD20/CD3 bispecific out of China (Endpoints)
  • Fifth of medicines in Africa may be sub-par or fake, research finds (The Guardian)
  • Canada Expands Expedited Reimbursement Mechanism To Include All New Medicines (Pink Sheet)
Pharma & Biotech
  • What the meltdown in the stock market means for biotech and pharma (Endpoints)
  • Bristol Myers telegraphs layoffs in New Jersey, trimming 117 jobs in staggered wave of cuts (Fierce)
  • Mallinckrodt to sell Therakos unit to CVC Capital for $925 mln (Reuters)
  • FDA ad comm favors Zevra’s Niemann-Pick drug (STAT)
  • Weight loss drugs without a prescription? Study warns it’s a ‘very risky business’ (STAT)
  • Bayer plans label expansion for Kerendia after Phase 3 win in heart failure (Endpoints)
  • Bristol Myers returns TIGIT bispecific to Agenus, frees itself from $1B+ milestones (Endpoints)
  • MBX Biosciences rakes in $63.5M for peptide therapies (Endpoints)
  • FDA wants new trial of Actinium’s radioactive iodine drug, company to seek partner (Endpoints)
  • Florida CNS gene therapy biotech shuts down (Endpoints)
Medtech
  • Genetic testing firm 23andMe rejects CEO's take-private offer (Reuters)
  • Testmaker Cepheid to cut more than 600 jobs at Silicon Valley headquarters (Fierce)
  • Inspire wins FDA approval for obstructive sleep apnea neurostimulator therapy (MedtechDive)
  • J&J launches Velys Spine surgical robotics and navigation platform (MedtechDive)
  • Experts fear patient harm from FDA’s lab developed test rule (MedtechDive)
Government, Regulatory & Legal
  • PTAB Told To Punish Mylan For Allegedly Breaking Fintiv Vow (Law360)
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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