ENTITY
FDA OKs Sarepta Study of New Immune Suppression Approach with Elevidys; Gilead Acquires Preclinical TREX1 Program
FDA; Sarepta; Elevidys; immunosuppression; Duchenne muscular dystrophy; Gilead; TREX1; gene therapy; sirolimus; acute liver injury
Dupixent Gains EU Approval as First Targeted Therapy for Chronic Spontaneous Urticaria in Over a Decade
Dupixent; chronic spontaneous urticaria (CSU); EU approval; Sanofi; Regeneron; monoclonal antibody; IL-4; IL-13; CUPID phase 3 trials; type 2 inflammation
Curapath and Cristal Therapeutics Sign Co-Exclusive License of CliCr Bioconjugation Platform
Curapath; Cristal Therapeutics; CliCr Bioconjugation Platform; co-exclusive license; nucleic acid delivery; CDMO; drug delivery
Zentek Appoints Mohammed Jiwan as CEO
Zentek; Mohammed Jiwan; CEO appointment; ZenGUARD; nanomaterials; graphene; technology; commercialization
Pharma Faces Supreme Court Deadline as IRA Price Negotiation Takes Effect
Inflation Reduction Act; SCOTUS; drug price negotiation; AstraZeneca; Medicare; pharmaceutical lawsuits; Fifth Amendment; supreme court petition; Farxiga; Centers for Medicare & Medicaid Services; price controls
Novartis Announces Plans to Lay Off 550 Workers at Swiss Factory
Novartis; layoffs; Switzerland; Stein facility; pharmaceutical manufacturing; restructuring; Schweizerhalle investment
Novo Nordisk’s Amycretin Significantly Reduces Weight and Blood Sugar in Phase 2 Type 2 Diabetes Trial
Novo Nordisk; Amycretin; Type 2 diabetes; Weight loss; HbA1c reduction; GLP-1 agonist; Amylin receptor agonist; Phase 2 clinical trial; Subcutaneous administration; Oral administration
FDA’s Pazdur Raises Concerns Over Legality of National Priority Voucher Program Amid Internal Disagreement
FDA; Pazdur; Commissioner’s National Priority Voucher; CNPV; legality; internal disagreement; tumor board; Tidmarsh; drug approval process
FDA Approves Novartis’ Itvisma: Expanding Gene Therapy to Older Spinal Muscular Atrophy Patients
Novartis; FDA approval; Itvisma; Zolgensma; Spinal Muscular Atrophy (SMA); Gene Therapy; Older Children; Adults; Intrathecal Formulation
ASH 2025: Breakthroughs in In Vivo CAR-T Data from Kelonia; Phase 3 Wins for Lilly, J&J, and Novartis
ASH 2025; in vivo CAR-T; Kelonia Therapeutics; KLN-1010; multiple myeloma; Johnson & Johnson; Lilly; Novartis; CAR-T therapy; Phase 3 trials