Drug Discovery - Research & Development

Atara receives FDA complete response letter for Ebvallo BLA application

Atara Biotherapeutics has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the biologics licence application (BLA) of Ebvallo (tabelecleucel).

Takeda and Halozyme sign global agreement for Enhanze technology

Takeda has announced a global collaboration and licence agreement with Halozyme to continue advancing vedolizumab with the latter’s Enhanze drug delivery technology.

Day One concludes Mersana Therapeutics acquisition

Day One Biopharmaceuticals has concluded its acquisition of Mersana Therapeutics after meeting all the tender offer conditions.

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.

Formycon and Zydus sign exclusive agreement for FYB206 supply

Formycon and Zydus Lifesciences have entered an exclusive licensing and supply agreement for FYB206, a biosimilar of MSD’s Keytruda (Pembrolizumab), in Canada and the US.