Recon: FDA denies Lykos MDMA drug; Pfizer reports positive late-stage results for RSV vaccine in immunocompromised adults

• 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)