Helixgate https://validator.w3.org/feed/docs/rss2.html Lilly’s GIP/GLP-1 Candidate Brenipatide Shows Early Clinical Promise in Substance, Psych Disorders Precure Selects Helix as Multiomics Lab and AI Tools Provider Inside the growing world of biopharma prediction markets 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 Beacon lights path to FDA approval with pivotal trial win for rare vision loss gene therapy Citing Replimune approval, experts say localized cancer meds could redefine care Mikhail, Davis on board with regulatory framework tailored to rare disease therapies Telomerase and β-Catenin Join Forces to Drive Aggressive Liver Cancer STAT+: Radiopharma companies merge after one receives surprise FDA rejection Ultragenyx gets FDA nod for first Sanfilippo A gene therapy Which biotechs have raised new VC financing this week? Cue chalks up phase 2 hives win for Xolair challenger MPs seek probe into UK-US pharma deal’s impact on NHS CHMP backs Novo’s haemophilia A drug Frehemgo Electra dips after pricing upsized IPO, bucking trend: Public Equity Report Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer EMA’s CHMP backs eight new medicines in September Ultragenyx wins first approval for MPS IIIA, closing a bumpy four-year path Fatal toxicities test autoimmune CAR T’s safety thesis STAT+: FDA approves a new gene therapy for Sanfilippo syndrome, an ultra-rare disease Roche agrees $1bn deal with Dualitas for bispecific antibody research Ona Therapeutics to develop ADC with WuXi’s payload-linker platform STAT+: Pharmalittle: We’re reading about FDA hiring delays, a new Bavarian Nordic CEO, and more First myostatin-targeted antibody approved for spinal muscular atrophy The value of speed for drug developers Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules STAT+: Pharmalittle: We’re reading about licensing deals with China, making drugs in space, and more STAT+: Roche expands its Boston footprint with new research center Data Standards Program Strategic Plan and Board Center for Drug Evaluation and Research Organization Chart New Approach Methodologies (NAMs) Database of Use Case Examples New Approach Methodologies (NAMs) CDER Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs) FDA Approves Therapy to Treat Ataxia in Patients with Ataxia-Telangiectasia, a Rare Genetic Disorder Project Orbis Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer H5N1 Spreads Among Australian Wildlife as Flu Season Ramps Up Generic Drugs Gene editing using large insertions BMS scraps Orum’s targeted degrader after reviewing Phase 1 data Ultragenyx wins FDA greenlight for first Sanfilippo therapy, priced at nearly $4M Home