Drug Manufacturing

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.

Insignis Therapeutics’ IN-001 clinical programme receives positive FDA response

Insignis Therapeutics has received a positive response from the US Food and Drug Administration (FDA) on IN-001 clinical programme for needle-free anaphylaxis treatment.

Electra Therapeutics secures FDA ODD status for HLH treatment

Electra Therapeutics has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for ELA026, an antibody therapy to treat hemophagocytic lymphohistiocytosis (HLH).

Shanghai Henlius Biotech, Organon announce FDA acceptance of BLA for HLX14

Shanghai Henlius Biotech (Henlius) and Organon have announced the US Food and Drug Administration (FDA) acceptance of the biologic license application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab).