Recon: FDA denies Lykos MDMA drug; Pfizer reports positive late-stage results for RSV vaccine in immunocompromised adults
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA declines to approve first MDMA-based PTSD treatment (Reuters)
- A tough week for MDMA-assisted psychotherapy (STAT)
- Getting to ‘Plan B’ for psychedelic medicine: Lessons from reproductive health (STAT)
- Some ‘inconvenient’ truths about pharmacy benefit managers (STAT)
- The FDA should withdraw approval of more than 400 tainted medicines (STAT)
- Pfizer touts strength of RSV vaccine in subgroup of younger immunocompromised patients (Endpoints) (Reuters)
- FDA delays approval decision on Humacyte’s lab-grown blood vessels (Endpoints)
- Ohio federal judge dismisses IRA suit brought by US Chamber of Commerce (Endpoints)
- Hello, neffy: FDA approves first nasal spray for severe allergic reactions (Endpoints)
- Genentech, Gilead push FDA to modernize research inspections (Endpoints)
- Amgen announces plans for new site in India to strengthen AI, data and life sciences (Endpoints)
- EU Experts Vollebregt and Melvin Agree Over Nature Of Changes Needed To MDR (Endpoints)
- Unilabs Signs Multi-Year Deal With C2N To Expand Alzheimer’s Test In Europe And Beyond (MedTech Insight)
- EMA Advances Use Of Real-World Data By HTAs And Payers (Pink Sheet)
- India Trial Waivers: New Drugs, CGTs Cleared In Specific Countries To Qualify (Pink Sheet)
- India's Zydus Lifesciences Q1 profit beats estimates on strong US demand (Reuters)
- Halda adds $126M to test oral drugs for prostate, breast cancer (Endpoints)
- Botox rival Revance to go private in $924 million deal (Reuters)
- Bill Haney's Dragonfly nabs former Cerevel CFO; Cellectis' new CMO (Endpoints)
- Exclusive: MIT spinout launches with focus on improving DNA payloads for gene insertion (Endpoints)
- Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath (Fierce Pharma)
- AbbVie’s Skyrizi, Rinvoq retake the top TV drug ad spenders’ crown as top climber Rexulti continues strong run (Fierce Pharma)
- Analysts tip Madrigal to target digestive scientific meetings to kick-start MASH growth (Fierce Pharma)
- AbbVie taps Melissa Joan Hart to explain it all at annual ‘Science of Skin’ event (Fierce Pharma)
- Legend Biotech CEO takes ‘close look at business’ amid geopolitical risk, M&A rumor (Fierce Pharma)
- How UnitedHealth turned a questionable artery-screening program into a gold mine (STAT)
- Developers of vapes for migraine, asthma will need to win over sceptics (Reuters)
- Smiths Medical recalls infusion pumps over software issues (MedTech Dive)
- Axogen names ex-Abbott exec Michael Dale as CEO (MedTech Dive)
- Solventum raises earnings forecast after first independent quarter (MedTech Dive)
- News We’re Watching: Medtronic Recall; FDA Approves Injector For Opioid Overdose; EKO Teams Up With LSU Tigers For Heart Monitoring (MedTech Insight)
- Digital Health Advisory Committee Announces Voting Members, Pool Of Industry Representatives (MedTech Insight)
- Big Health Gets Good Night Sleep With FDA Approval Of Insomnia Digital Therapeutic (MedTech Insight)
- Slow Burn: US FDA RMAT Designations Surge While Breakthrough Pace Softens (Pink Sheet)
- Controlling obesity is a noble goal. Controlling mpox is a far more urgent one (STAT)
- Cancer Drug Dosage Optimization Starts With US FDA Meetings Early In Development (Pink Sheet)
- J&J has enough support from claimants for $6.5 billion talc settlement – Bloomberg (Reuters)
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