Drug Discovery

Oricell’s OriCAR-017 application secures FDA IND clearance

Oricell Therapeutics has announced the clearance of its Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for OriCAR-017, a new CAR-T cell therapy targeting GPRC5D, for the treatment of relapsed/refractory multiple myeloma (R/R MM).

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.

Zokinvy gets Japanese approval for Progeria treatment

The Progeria Research Foundation (PRF) has announced the Japanese approval of Zokinvy (lonafarnib) for treating Progeria and processing-deficient Progeroid Laminopathies (PL).

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).

AOB Pharma, Maruho partner to develop B244 for inflammatory ailments

AOB Pharma has signed an exclusive license and development agreement with Maruho for the development and marketing of its topical biologic, B244, for inflammatory indications in Japan.

AGC Biologics to build new facility in Japan

AGC Biologics has announced the establishment of a new manufacturing site at the AGC Yokohama Technical Center in Japan.

WuXi XDC, IntoCell partner for drug-linker technology and CRDMO services

WuXi XDC, a China-based CRDMO specialising in antibody drug conjugates (ADCs) and the broader bioconjugate market, has entered into a memorandum of understanding (MoU) with South Korea's IntoCell.

Innovent and SanegeneBio partner for hypertension drug development

Innovent Biologics has signed a partnership agreement with Sanegene Bio to jointly develop an angiotensinogen (AGT) directed siRNA drug candidate, SGB-3908, to treat hypertension.