Drug Discovery

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).

Santhera’s vamorolone NDA receives priority review in China

Santhera Pharmaceuticals has reported that the China National Medical Products Administration (NMPA) granted priority review for a new drug application (NDA) for vamorolone, for Duchenne muscular dystrophy (DMD).

Q32 Bio concludes merger deal with Homology Medicines

Clinical stage biotechnology company Q32 Bio has announced the conclusion of its merger with Homology Medicines, for an undisclosed sum.

EMA CHMP recommends marketing authorisation for Novartis’ PNH treatment

Novartis has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorisation for Fabhalta (iptacopan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who suffer from haemolytic anaemia.

Evommune expands EVO756 collaboration with Maruho in Asia

Evommune has announced an expanded strategic partnership with Maruho for the development and commercialisation of EVO756 in Greater China and some Asian countries.

FDA committee recommends BMS-2seventy’s Abecma

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted in favour of Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) for treating triple-class exposed relapsed or refractory multiple myeloma.

Tubulis secures $138.8m to develop ADCs for solid tumours

Tubulis has secured €128m ($138.8m) in a Series B2 financing round to expedite the clinical development of its antibody drug conjugates (ADCs) pipeline, focused on solid tumours.