Oncology

Bristol Myers gets positive opinion from CHMP for Opdivo

Bristol Myers Squibb has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) which recommended approval on Opdivo (nivolumab) for use as an adjuvant treatment in patients with completely resected stage IIB or IIC melanoma.

Janssen seeks US FDA approval of new indication for Carvykti

The Janssen Pharmaceutical Companies of Johnson & Johnson is seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) from the US Food and Drug Administration (FDA) through submission of a supplemental Biologics License Application (sBLA).

FDA gives approval to cell therapy Omisirge for blood cancer patients

The US Food and Drug Administration has granted approval to Gamida Cell for Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy.

Caris Life Sciences and Flare to collaborate for oncology pipeline advancement

Caris Life Sciences and Flare Therapeutics have announced a partnership to advance the precision oncology pipeline of the latter into clinical trials.

TÜBITAK, MAM to produce drugs and vaccines on pilot scale in Türkiye

Marmara Research Center (MAM) and The Scientific and Technological Research Council of Türkiye (TÜBITAK) have commenced Medical Biotechnology Research Center (MEDIBIYO) for the production of drugs and vaccines on a pilot scale, reported Daily Sabah.

Mosaic Therapeutics raises $28m from Series A round to advance oncology therapies

UK-based oncology therapeutics company Mosaic Therapeutics has raised $28m from series A funding round.

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.