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.
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).
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 Therapeutics have announced a partnership to advance the precision oncology pipeline of the latter into clinical trials.
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.
UK-based oncology therapeutics company Mosaic Therapeutics has raised $28m from series A funding round.
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 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, a clinical stage contract development and manufacturing organisation (CDMO), has completed capital raise of $15m from Series B round.
Sumitovant Biopharma has closed the acquisition of Myovant Sciences in an all-cash deal with a total transaction value of around $1.7bn.
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