Drug Discovery

Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis

Cellenkos has received orphan drug designation from the US Food and Drug Administration (FDA) for its investigational CK0804 regulatory T cell (Treg) therapy to treat myelofibrosis, a rare blood cancer.

Zai Lab’s Augtyro receives NMPA approval for solid tumours in China

Zai Lab has received approval from China’s National Medical Products Administration (NMPA) for the supplemental new drug application (sNDA) for Augtyro (repotrectinib) to treat adult patients with solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

Takeda and Protagonist seek FDA approval for rusfertide to treat PV

Takeda and Protagonist Therapeutics have jointly submitted a new drug application (NDA) seeking approval from the US Food and Drug Administration (FDA) for rusfertide to treat adults with polycythemia vera (PV).

Insilico and Servier announce $888m oncology research agreement

Insilico Medicine has entered a multi-year research and development (R&D) collaboration with Servier, worth up to $888m, to develop and discover new oncology therapies.

MEDIPOST, Teikoku Seiyaku partner for CARTISTEM commercialisation in Japan

MEDIPOST has announced a multi-year exclusive partnership with Teikoku Seiyaku to commercialise CARTISTEM, an allogeneic stem cell therapy for moderate to severe knee osteoarthritis, in Japan.

Harbour BioMed and BMS sign multi-specific antibody collab

Harbour BioMed and Bristol Myers Squibb (BMS) have signed a multi-year, worldwide strategic partnership and licence agreement focused on multi-specific antibody discovery and development.

INCOG reveals $200m injectable drug expansion in Indiana

Contract development and manufacturing organisation (CDMO) INCOG BioPharma Services has announced injectable drug manufacturing expansion at its Fishers facility in the US state of Indiana, with an investment of around $200m.

LEO Pharma applies to EMA to expand Anzupgo use to adolescents

LEO Pharma has submitted an application to the European Medicines Agency (EMA) seeking to expand the label for Anzupgo (delgocitinib) cream to include adolescents aged from 12 to 17 with moderate to severe chronic hand eczema (CHE) in the European Union (EU).

SK Capital Partners supports Swixx BioPharma’s global expansion

US-based private investment company SK Capital Partners’ affiliate has agreed to invest in Swixx BioPharma to support the latter’s next stage of growth and international expansion.