Drug Manufacturing

Laekna partners with Lilly to develop obesity therapy

Laekna has entered into a clinical partnership with Eli Lilly to advance the development of LAE102, a new ActRIIA monoclonal antibody for treating obesity.

FDA grants ODD to Ractigen Therapeutics’ RAG-21 for ALS treatment

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Ractigen Therapeutics' new therapy, RAG-21, targeting the fused in sarcoma (FUS) gene, for amyotrophic lateral sclerosis (ALS) treatment.

Arrowhead Pharmaceuticals submits plozasiran NDA to treat FCS

Arrowhead Pharmaceuticals has submitted a new drug application (NDA) for plozasiran to the US Food and Drug Administration (FDA) to treat familial chylomicronemia syndrome (FCS).

FDA to review Sanofi, Regeneron’s Dupixent sBLA for CSU

The US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU) in adults and children aged 12 and above, particularly for those whose condition persists despite H1 antihistamine treatment.

Asha Therapeutics secures grant for ALS therapeutic development

Asha Therapeutics has received a grant from the ALS Association through its Lawrence and Isabel Barnett Drug Development Program for advancing ASHA-624 to treat amyotrophic lateral sclerosis (ALS).

AstraZeneca and Daiichi Sankyo submit BLA to FDA for lung cancer treatment

AstraZeneca and Daiichi Sankyo have submitted a new biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking accelerated approval for datopotamab deruxtecan (Dato-DXd) to treat non-small cell lung cancer (NSCLC).

Alteogen and Daiichi Sankyo sign license deal for ADC development

Alteogen has entered into an exclusive license agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous version of ENHERTU (fam-trastuzumab deruxtecan-nxki), an antibody drug conjugate (ADC).

New England Biolabs opens new manufacturing facility in UK

New England Biolabs (NEB) has expanded its global footprint with the opening of NEB Lyophilization Sciences (NEB Lyo Sciences), a manufacturing facility in the UK.

Plus Therapeutics partners with SpectronRx for CNS therapy development

Plus Therapeutics has entered into a manufacturing services agreement (MSA) with SpectronRx to produce the radiotherapy, Rhenium (186Re) Obisbemeda, for central nervous system (CNS) cancers.