Cornerstone Pharmaceuticals has announced that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) to CPI-613 (devimistat) to treat advanced unresectable biliary tract cancer.
Biotechnology firm Inceptor Bio has raised $37m from Series A funding round that was led by Kineticos Ventures.
Proteros biostructures has expanded its collaboration with AstraZeneca focused on the discovery and development of novel epigenetic drugs.
Moma Therapeutics has completed a $150m Series B financing led by Goldman Sachs Asset Management for advancement of several precision oncology programmes to clinical trials.
InxMed has raised $15m in Series B+ financing funded by Hyfinity Investments to advance new therapies for the treatment of drug-resistant cancers.
Sapience Therapeutics has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its lead programme, ST101, to treat advanced melanoma for patients in stages IIB through IV.
Daiichi Sankyo and AstraZeneca’s ENHERTU (fam-trastuzumab deruxtecan-nxki) has secured breakthrough therapy designation (BTD) in the US to treat adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.
The US Food and Drug Administration (FDA) has accepted for review AstraZeneca’s Biologics License Application (BLA) for tremelimumab to treat patients with unresectable hepatocellular carcinoma (HCC).
Tvardi Therapeutics, a clinical-stage biopharmaceutical company, has announced receipt of orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its lead product, TTI-101, to treat hepatocellular carcinoma (HCC).
Bristol Myers Squibb has obtained approval from the US Food and Drug Administration (FDA) for Opdualag (nivolumab and relatlimab-rmbw) to treat unresectable or metastatic melanoma patients.
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