Recon: FDA rejects Xspray’s Dasynoc over dosing and manufacturing concerns; EMA expands investigations into suicide risks of GLP-1 drugs
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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