Oncology

Volastra in-licenses Amgen’s KIF18A inhibitor sovilnesib

Volastra Therapeutics has concluded the in-licensing of Amgen’s oral, first-in-class small molecule KIF18A inhibitor, sovilnesib (AMG650).

Xspray Pharma and Eversana sign agreement for US launch of cancer therapy

Xspray Pharma and Eversana have signed an agreement for the launch and commercialisation of the former’s cancer therapy Dasynoc (XS004) in the US to treat chronic myeloid leukaemia (CML) and acute lymphatic leukaemia (ALL).

Fresenius Kabi introduces pegfilgrastim biosimilar for cancer patients in US

Global health care company Fresenius Kabi has launched Stimufend (pegfilgrastim-fpgk), its pegfilgrastim biosimilar, for cancer patients in the US.

GSK receives approval from FDA for Jemperli

GSK has received full approval from the US Food and Drug Administration (FDA) for its programmed death receptor-1 (PD-1)-blocking antibody Jemperli (dostarlimab-gxly) to treat adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.

Purple Biotech signs agreement to acquire Immunorizon

Purple Biotech has signed an agreement to acquire Immunorizon, which develops potential multi-specific T and NK cell engager oncology therapies.

US FDA grants fast track designation to Artiva’s lead programme AB-101

The US Food and Drug Administration (FDA) has granted fast track designation to clinical stage company Artiva Biotherapeutics’s lead programme AB-101.

TScan Therapeutics receives FDA clearance for IND applications

TScan Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) applications for T-Plex, TSC-204-A0201, and TSC-204-C0702.

Genexine receives FTD for DNA vaccine to treat advanced cervical cancer

Genexine has received the Korean Ministry of Food and Drug Safety’s (MFDS) fast track designation (FTD) for its first-in-class proprietary therapeutic DNA vaccine, GX-188E (tirvalimogene teraplasmid), for advanced cervical cancer.

US FDA grants fast track designation to Evaxion Biotech’s personalised cancer therapy

The US Food and Drug Administration (FDA) has granted fast track designation to Evaxion Biotech’s personalised cancer therapy, EVX-01, in combination with KEYTRUDA.