Helixgate https://validator.w3.org/feed/docs/rss2.html How J&J paved the way for Compass’ coming psychedelic drug launch Telix buys ITM in bid to create a ‘radiopharmaceutical powerhouse’ Beacon eye gene therapy hits mark in late-stage study Novo talks up drug launches in effort to win back investors Telix to buy radiopharma rival ITM for $1.65bn upfront Beacon’s XLRP gene therapy set for filing after phase 3 win Advocacy group pokes holes in Trump’s MFN pricing claims PDUFA VIII aims to remove CMC bottlenecks, shore up FDA staffing Chugai’s Lasker winners aim to beat their own blockbuster Biotech IPOs, CAR T safety, and pharma tariffs — a BioCentury podcast Telix-ITM merger aims to create radiopharma juggernaut: Deals Report Beacon edges ahead in XLRP gene therapy race with Phase III hit Novo buys three early-stage obesity assets from Kallyope as investor pressure mounts Telix buys ITM for $1.65B in ‘supercritical’ radiopharma M&A Novo’s plan to hit $23B in revenue by 2035 leaves investors wanting Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts Deep Dive: How AI is now essential in biopharma Sandoz and mAbxience agree on emicizumab biosimilar partnership Telix to acquire ITM in deal worth up to $2.35bn STAT+: With new strategy, Novo outlines plans for obesity, direct-to-consumer work STAT+: Lilly’s breast cancer combo wins approval Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules A hidden tradeoff in Trump’s MFN drug deals FDA Roundup: July 26, 2024 FDA Roundup: June 18, 2024 FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter Two trials or not two trials? That should not be the question The evolving landscape of drug targets Condition-Specific Meeting Reports and Other Information Related to Patients’ Experience H5N1 Spreads Among Australian Wildlife as Flu Season Ramps Up Precure Selects Helix as Multiomics Lab and AI Tools Provider Andelyn Curator Biomanufacturing Platform Supports Fayuvi Gene Therapy Approval OncoC4 Receives FDA Fast Track Designation for Cesalatamig, an Investigational PD-1/VEGF Bispecific Antibody Efzimfotase Alfa Granted Priority Review in the US as Treatment for Patients with Hypophosphatasia Aged 2 Years and Older AI-powered barcode unmasks ‘zombie cells’ in aging tissue With pioneering ADHD data, Alkermes eyes orexin agonist as potential ‘company changer’ China targets 25% share of global first-in-class drugs in new 5-year plan Analysts ‘extremely bullish’ as Telix beams into Novartis’ territory with $1.6B ITM acquisition Retension and Lilly-backed TRex Bio both set out plans to join biotech IPO stampede Cue chalks up phase 2 hives win for Xolair challenger Beacon lights path to FDA approval with pivotal trial win for rare vision loss gene therapy J&J again cuts New Jersey workforce, letting 87 go STAT+: Radiopharma companies merge after one receives surprise FDA rejection Drugs@FDA Data Files FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development New Approach Methodologies (NAMs) Citing Replimune approval, experts say localized cancer meds could redefine care Home