Central Nervous SystemRegulationApprovals July 24, 2026 FDA grants fast track designation for Lundbeck’s Lu AH69593 By Salong Debbarma Lu AH69593 is an oral, small-molecule agonist of the orexin 2 receptor (OX2R). The compound is currently being studied in a Phase Ib clinical trial focused on patients
CardiovascularBiotechnology July 23, 2026 Evogene and ELEO to develop new oral PCSK9 inhibitors By Salong Debbarma As part of the collaboration, Evogene will use its ChemPass AI platform, a computational chemistry system aimed at generative molecular design, to create, optimise, and rank prospective small-molecule
CardiovascularRegulationApprovals July 23, 2026 Affinia Therapeutics receives FDA orphan drug designation for AFTX-201 By Salong Debbarma The gene therapy is under investigation in adults living with BAG3 DCM, a genetic condition that leads to progressive heart failure and reduced survival despite existing treatments. AFTX-201
Research & DevelopmentRegulation July 22, 2026 Kyowa Kirin EMEA’s Crysvita approved by EC for infants with XLH By Salong Debbarma The announcement follows a positive recommendation issued in April 2026 by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). This regulatory action permits
BiotechnologyCell Culture and Cell Therapy July 22, 2026 Cellares and Papillon partner for PPL-001 manufacturing automation By Salong Debbarma PPL-001 is a gene-corrected haematopoietic stem and progenitor cell (HSPC) therapy. Under the collaboration, Cellares will adapt the PPL-001 manufacturing process for its Cell Shuttle platform, and support
BiotechnologyCell Culture and Cell Therapy July 21, 2026 EMA’s CHMP grants PRIME status to AbelZeta’s C-CAR168 By Salong Debbarma An autologous anti-cluster of differentiation 20/B-cell maturation antigen (CD20/BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, C-CAR168 aims to treat refractory systemic lupus erythematosus (SLE), with or without lupus
Drug DeliveryHematological Disorders July 21, 2026 Halozyme and Incyte sign licence agreement for INCA033989 formulations By Salong Debbarma The partnership will use Halozyme’s Enhanze drug delivery technology to potentially improve the convenience of administering INCA033989. Incyte will evaluate the benefits of the technology in creating subcutaneous
BiotechnologyContract Manufacturers July 20, 2026 Samsung Biologics to acquire PolyPeptide in $1.81bn cash deal By Salong Debbarma The proposed offer is set at SFr44.31 per share for 100% of PolyPeptide’s fully diluted share capital, excluding treasury shares. Completion of the deal is anticipated towards the
Drug DeliveryPharmaceuticals and Healthcare July 20, 2026 Aptar unveils framework for injectable drug delivery systems By Salong Debbarma The framework will enable pharmaceutical partners to access integrated data packages combining system-level testing and performance data for injectable therapies. Aptar Pharma stated that demand for earlier insight
RegulationResearch & Development July 17, 2026 FDA grants traditional approval to Novartis’ Fabhalta for IgAN By Salong Debbarma This first-in-class complement inhibitor received the approval through a priority review process after its initial accelerated approval in August 2024 for reducing proteinuria in primary IgAN. Results from