Eisai has submitted a new drug application seeking approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for Leqembi’s (lecanemab) subcutaneous (SC) formulation (SC-AI) for early Alzheimer’s disease.
Lupin has received US Food and Drug Administration (FDA) approval for Armlupeg (pegfilgrastim-unne) 6mg/0.6ml injection in a single-dose prefilled syringe for subcutaneous use as a biosimilar to Neulasta (pegfilgrastim).
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).
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Roche Products’ inavolisib (Itovebi) to treat adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.
The US Patent and Trademark Office (USPTO) has granted a patent to Genprex for the use of its Reqorsa gene therapy in conjunction with programmed death-ligand 1 (PD-L1) antibodies such as Tecentriq (atezolizumab) for cancer treatment.
March Biosciences (March Bio) has received US Food and Drug Administration (FDA) regenerative medicine advanced therapy (RMAT) designation for MB-105, an autologous CD5-targeted CAR-T cell therapy under development for relapsed/refractory CD5-positive T-cell lymphoma.
Alvotech and Advanz Pharma have announced the receipt of marketing authorisations from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for all four formulations of Gobivaz – Alvotech’s biosimilar to Simponi (golimumab).
Leukogene Therapeutics has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for M2T-CD33 (LTI-214), its immunotherapy candidate targeting acute myeloid leukaemia (AML).
Norway-based biotechnology company Calluna Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead clinical candidate, CAL101.
Biogen has entered into a licence agreement securing global rights to Vanqua Bio’s oral, preclinical C5aR1 antagonist.
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