Research & Development

Invenra, Astellas sign bispecific antibody discovery agreement

Invenra and Astellas Pharma have signed a strategic research agreement in therapeutic bispecific antibody discovery.

US FDA grants breakthrough status to Dizal’s sunvozertinib

Dizal Pharmaceutical has obtained breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its sunvozertinib for the first-line treatment of individuals with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.

US FDA grants orphan drug designation to Biostar Pharma’s utidelone

Biostar Pharma has announced that its pipeline product, utidelone injectable (UTD1), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of breast cancer brain metastasis (BCBM).

Everest Medicines to terminate deal with Providence for mRNA platform

Everest Medicines has announced plans to terminate its partnership and licence agreements with Providence Therapeutics for the development of products using its mRNA platform.

Precision receives payments from TG Therapeutics for azer-cel

Precision BioSciences has received upfront cash payment and equity investment totalling $17.5m from TG Therapeutics for an exclusive licence to develop Azercabtagene Zapreleucel (azer-cel).

Aizon secures funds to accelerate development pipeline

Aizon, an artificial intelligence (AI) Software as a Service (SaaS) provider for pharmaceutical manufacturing operations, has secured $20m in Series C funding to expedite its development pipeline.

NIH grants $9m for nicotine cessation drug development

The US National Institutes of Health (NIH) unit National Institute on Drug Abuse (NIDA) has granted an award of $9m for researchers to advance drug, SBP-9330, to treat nicotine addiction.

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).

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).