Drug Discovery

FDA approves Eli Lilly’s Jaypirca in relapsed or refractory CLL/SLL

Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for the expanded use of Jaypirca (pirtobrutinib) tablets, in 100mg and 50mg doses, to treat adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

AGC Biologics to expand cell line development with ATUM partnership

AGC Biologics is set to expand its Cell Line Development Centre of Excellence through a partnership with ATUM for integrating the Leap-In transposase expression platform into its services.

Citizen Health and UCB collaborate for epilepsy drug development

Citizen Health has entered a multi-year strategic partnership with UCB for expediting drug development across five rare diseases and epilepsy.

Solid Biosciences’ SGT-212 gains FDA rare paediatric disease status

Solid Biosciences has secured the US Food and Drug Administration (FDA) rare paediatric disease designation for SGT-212, its investigational gene therapy targeting Friedreich’s ataxia (FA).

IASO Bio gains Hong Kong approval for Fucaso application

IASO Biotechnology has received the Hong Kong Department of Health’s approval for its biologics licence application (BLA) for the fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, Fucaso (Equecabtagene Autoleucel), for adults with relapsed or refractory multiple myeloma (R/R MM).

BeOne’s sonrotoclax gains priority FDA review for mantle cell lymphoma

The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for BeOne Medicines’ B-cell lymphoma 2 (BCL2) inhibitor, sonrotoclax, and granted it priority review for use in treating adults with relapsed or refractory mantle cell lymphoma (R/R MCL).

UNICEF and Gavi to widen affordable malaria vaccine access

UNICEF and Gavi, the Global Alliance for Vaccines and Immunisation now known as the Vaccine Alliance, have announced a pricing deal to expand access to the R21/Matrix-M malaria vaccine, aiming to protect almost seven million more children from the disease.

FDA grants accelerated approval for Otsuka’s IgAN therapy

Otsuka Pharmaceutical has secured accelerated approval from the US Food and Drug Administration (FDA) for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at disease progression risk.

Novartis secures approval from FDA for Itvisma to treat SMA

Novartis has received approval from the US Food and Drug Administration (FDA) for the Itvisma (onasemnogene abeparvovec-brve) gene replacement therapy to treat spinal muscular atrophy (SMA).