Regulation

Eisai seeks PMDA approval for subcutaneous Leqembi in Japan

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.

US FDA approves Lupin’s Armlupeg injection

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 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).

MHRA approves Roche Products’ inavolisib for breast cancer

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.

USPTO grants patent to Genprex’s Reqorsa gene therapy

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 Bio’s MB‑105 gains FDA RMAT for CD5+ T‑cell lymphoma

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 announce MHRA marketing authorisations for Gobivaz

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 gains FDA ODD status for M2T-CD33

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).

Calluna secures FDA orphan drug designation for CAL101 in IPF

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.