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)
- 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)
- 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)
- 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)
- PTAB Told To Punish Mylan For Allegedly Breaking Fintiv Vow (Law360)
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