Drug Discovery

FDA grants fast track designation for Elevation Oncology’s EO-3021

The US Food and Drug Administration (FDA) has granted fast track designation for Elevation Oncology’s EO-3021, a treatment for patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer.

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

ENCell has entered into a strategic alliance and licencing agreement with Lucy Biotech for EN001, a next-generation mesenchymal stem cell therapy.

Osivax and KM Biologics sign deal for influenza vaccine in Japan

France-based biopharmaceutical company Osivax has entered into an exclusive license option agreement with Japanese vaccine manufacturer KM Biologics for a broad-spectrum “universal” influenza vaccine candidates in Japan.

Superluminal Medicines secures $120m in Series A funding round

Superluminal Medicines secured $120m in a Series A funding round to advance the development of its assets into clinical trials.

Novartis begins construction works at two RLT manufacturing facilities in US

Novartis has announced the commencement of construction on two new radioligand therapy (RLT) manufacturing facilities in the US, in a bid to expand its production and supply chain capabilities in the sector.

Skyline Therapeutics secures FDA orphan drug status for RP therapy

Skyline Therapeutics has announced that the US Food and Drug Administration (FDA) granted orphan drug designation (ODD) to its gene therapy, SKG1108, for the treatment of Retinitis Pigmentosa (RP), an inherited retinal disease.

Johnson & Johnson seeks FDA approval for generalised myasthenia gravis therapy

Johnson & Johnson has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of nipocalimab, aimed at treating individuals with generalied myasthenia gravis (gMG).

Bayer partners with NextRNA to develop lncRNA-targeting cancer therapies

Bayer has announced a strategic partnership with NextRNA Therapeutics to develop long non-coding RNAs (lncRNAs)-targeting small molecule therapeutics for cancer treatment.

FDA grants orphan drug status for RedHill’s opaganib for neuroblastoma

The US Food and Drug Administration (FDA) has granted orphan drug designation to RedHill Biopharma's opaganib for the treatment of neuroblastoma, a childhood cancer.