Oncology

US FDA grants ODD to NeoImmuneTech’s NT-I7 for pancreatic cancer treatment

NeoImmuneTech, a company specialising in T cell-focused therapeutics, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its NT-I7 (efineptakin alfa) (rhIL-7-hyFc), for the treatment of pancreatic cancer.

EMA validates Pfizer-Astellas’ bladder cancer therapy application for review

The European Medicines Agency (EMA) has validated for review a Type II variation application for Pfizer and Astellas Pharma’s PADCEV (enfortumab vedotin) with KEYTRUDA (pembrolizumab) as first-line therapy option for locally advanced or metastatic urothelial cancer (la/mUC).

UroGen submits new drug application to FDA for UGN-102

UroGen Pharma has submitted the Chemistry, Manufacturing, and Controls (CMC) section of the new drug application (NDA) to the US Food and Drug Administration (FDA) for UGN-102, to treat urothelial cancers.

ASTCT, ACCC and AACI launch initiative for CAR T therapy

The American Society for Transplantation and Cellular Therapy (ASTCT), the Association of Community Cancer Centers (ACCC) and the Association of American Cancer Institutes (AACI) have launched the RECUR initiative to improve patient access to CAR T therapy.

CARsgen’s CT011 receives IND clearance from China’s NMPA

CARsgen Therapeutics has announced that its autologous CAR T-cell product candidate, CT011, received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) in China.

GENESIS and Deciphera enter distribution agreement for Ripretinib

GENESIS Pharma has entered into an exclusive distribution agreement with Deciphera Pharmaceuticals for the marketing of Ripretinib in 14 European Union (EU) markets in Central and Eastern Europe.

FDA grants two designations for GenFleet’s drug candidate SLS009

Chinese biotechnology company GenFleet Therapeutics has received the US Food and Drug Administration (FDA) designations for its drug candidate SLS009 (GFH009).

Simcha Therapeutics signs license agreement with Janssen for DR-18

Clinical-stage immunobiology company Simcha Therapeutics has signed a licence and option agreement with Johnson & Johnson subsidiary Janssen Biotech for new decoy-resistant IL-18 (DR-18).

Eli Lilly concludes POINT Biopharma acquisition for $1.4bn

Eli Lilly and Company has concluded the acquisition of all outstanding shares of radiopharmaceutical company POINT Biopharma in a deal valued at nearly $1.4bn.