Oncology

Akamis secures funds to advance cancer therapy through study

Akamis Bio has secured $60m in funding, marking the close of a Series A Prime financing round, which will propel the development of its clinical candidate, NG-350A, for treating locally advanced rectal cancer (LARC), through study.

Sanofi’s multiple sclerosis therapy gains breakthrough therapy status from FDA

Sanofi’s oral bioactive Bruton’s tyrosine kinase (BTK) inhibitor tolebrutinib has gained breakthrough therapy designation from the US Food and Drug Administration (FDA) for treating the adult population with non-relapsing secondary progressive multiple sclerosis (nrSPMS).

Tanner-Agenus partner for expanded access to immunotherapies for cancer patients

Tanner Pharma has partnered with Agenus to offer expanded access to investigational immunotherapies, botensilimab (BOT) and balstilimab (BAL), for individuals with microsatellite stable colorectal cancer (MSS CRC) and other advanced solid tumours.

FDA accepts Crinetics Pharmaceuticals’ NDA for acromegaly treatment therapy

The US Food and Drug Administration (FDA) has accepted Crinetics Pharmaceuticals' paltusotine new drug application (NDA) as a long-term maintenance and potential treatment for acromegaly in the adult population.

Gilead and Tubulis sign ADC development deal for cancer treatment

Gilead Sciences has entered into an exclusive option and license agreement with German biotechnology company Tubulis to develop an antibody-drug conjugate (ADC) aimed at treating solid tumours.

Dr. Reddy’s Laboratories introduces Toripalimab in India for nasopharyngeal carcinoma

Dr. Reddy's Laboratories has launched Toripalimab, the only immuno-oncology drug approved by global regulatory authorities for the treatment of nasopharyngeal carcinoma (NPC), in India.

China’s NMPA grants marketing approval to Kelun-Biotech’s sac-TMT for TNBC treatment

The China’s National Medical Products Administration (NMPA) has granted marketing authorisation to Sichuan Kelun-Biotech Biopharmaceutical’s sacituzumab tirumotecan (sac-TMT), a domestically developed trophoblast cell surface antigen 2 (TROP-2)-directed antibody-drug conjugate (ADC) for the treatment of the adult population with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).

Numab Therapeutics and Kaken Pharmaceutical collaborate to develop ND081

Numab Therapeutics and Kaken Pharmaceutical have entered into a partnership and option agreement for the development of ND081, a multi-specific antibody designed as a potential first-in-class treatment for inflammatory bowel disease (IBD).

AstraZeneca and Daiichi Sankyo submit BLA to FDA for lung cancer treatment

AstraZeneca and Daiichi Sankyo have submitted a new biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking accelerated approval for datopotamab deruxtecan (Dato-DXd) to treat non-small cell lung cancer (NSCLC).