Recon: FDA rejects Xspray’s Dasynoc over dosing and manufacturing concerns; EMA expands investigations into suicide risks of GLP-1 drugs

• FDA rejects Xspray’s would-be rival to Bristol Myers’ Sprycel on dosing, manufacturing concerns  (Fierce)
• Bristol Myers’ Opdivo stages comeback in bladder cancer, teeing up 2 ‘Merck’ showdowns (Fierce)
• Cell/Gene Therapies: US FDA Wants ‘Quantitative Correlation' Between Surrogate And Clinical Outcome, Former Reviewer Says (Pink Sheet)
• New Translational Science Team Created In US FDA’s CDER To Aid Rare Disease Drug Development (Pink Sheet)
• Melinta secures $142M BARDA deal to target pediatric and 'biothreat' indications for antibiotics (Endpoints)
• Explosion of Overdoses Prompts Biden Action on Deadly Drug Combo (Bloomberg) (STAT)
• Exclusive: Most patients using weight-loss drugs like Wegovy stop within a year, data show (Reuters)

• EMA Probe Into Suicide Risk With Liraglutide & Semaglutide Extended To Other GLP-1 Receptor Agonists (Pink Sheet) (Seeking Alpha)
• Novo Nordisk says Wegovy launch in Germany won't hit U.S. supplies (Reuters)
• China launches campaign to crack down on illegal fertility treatments (Reuters)
• Brazil and Argentina Join Talks To Create Latin American & Caribbean Regulator (Pink Sheet)
• Poisoned Cough Syrup Killed Kids. An Investigation Stalled (Bloomberg) (Financial Express)
• Companies Could Get £20m Under Expanded UK Payment Model For Incentivizing Antibiotic Development (Pink Sheet)
• UK Generics Body Denied In Bid To Negotiate Over VPAS Rebate Scheme (Pink Sheet)

• Astellas Licenses 4DMT’s Vector Delivery Platform in Potential $962M Deal (BioSpace) (Fierce)
• Septerna’s $150M infusion will help prove whether it’s got the right pill for hypoparathyroidism (Endpoints) (Fierce)
• BMS Pays Combined $95M to Evotec, Prothena for Neuro-Focused Options (BioSpace)  (Fierce)
• Exclusive: Pfizer to invest $25M into tiny UK biotech with epigenetics approach to cancer (Endpoints)
• Eisai executive who helped lead development of Alzheimer’s drug to retire (STAT) (Endpoints)
• Viridian looks over Horizon after eye disease med notches early improvements (Fierce)
• Apogee, Sagimet move forward with IPO plans, revealing $228M and $66M offers (Fierce)
• Cell death biotech BAKK dissolves in ‘challenging funding environment’ (Fierce)
• A new study of sick infants sees potential in DNA sequencing, but also a need for better ways to interpret the genome (STAT)

• Better Therapeutics’ first digital app earns FDA de novo nod in Type 2 diabetes (Fierce)
• Automated machine learning model identifies patients at risk for surgical complications (MedTech Dive)
• Medtech M&A, VC funding slowed to snail’s pace in the first half of 2023: Evaluate (Fierce)
• Medtronic secures Medicare coverage for MiniMed 780G insulin pump (MedTech Dive)
• CyMedica rebrands knee pain band under direct-to-consumer Motive Health (Fierce)

• Novartis faces one win, one loss in patent cases over blockbuster heart failure drug (Endpoints)
• Alabama Hospitals Hard Hit by Opioids Take Case to State Court (Bloomberg)