Oncology

FDA grants fast track status to Prestige’s PBP1510 for pancreatic cancer

The US Food and Drug Administration has granted fast track designation to Prestige Biopharma’s PBP1510 (Ulenistamab) to treat unresectable or metastatic pancreatic adenocarcinoma (PDAC).

Orion receives approval from Chinese NMPA for darolutamide

Orion has received approval from the Chinese National Medical Products Administration (NMPA) for darolutamide along with docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients.

Evergreen Theragnostics raises $15m from Series B round

Evergreen Theragnostics, a clinical stage contract development and manufacturing organisation (CDMO), has completed capital raise of $15m from Series B round.

Sumitovant Biopharma completes acquisition of Myovant Sciences

Sumitovant Biopharma has closed the acquisition of Myovant Sciences in an all-cash deal with a total transaction value of around $1.7bn.

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.