Drug Manufacturing

China’s NMPA approves Fosun’s NDA of Tenapanor Hydrochloride tablets

China’s National Medical Products Administration (NMPA) has granted approval to the new drug application (NDA) of Shanghai Fosun Pharmaceutical Industrial Development’s phosphate absorption inhibitor, Tenapanor Hydrochloride tablets, intended for controlling levels of serum phosphorus in dialysis patients with chronic kidney disease (CKD).

Health Canada grants marketing authorisation to Kashiv’s Pegfilgrastim

Health Canada has granted marketing authorisation to Kashiv BioSciences’ long-acting G-CSF biosimilar, Pegfilgrastim injection.

Biocon Biologics launches ustekinumab biosimilar in US

Biocon Biologics, a subsidiary of Biocon, has launched Yesintek (ustekinumab-kfce), a biosimilar to Stelara, in the US.

Tiziana partners with Renaissance for intranasal foralumab production

Tiziana Life Sciences has entered into a product development services agreement with US contract development and manufacturing organisation (CDMO) Renaissance Lakewood aimed at improving the present formulation and enhancing the production of intranasal foralumab.

Genmab’s epcoritamab gains approval in Japan for lymphoma treatment

The Japan’s Ministry of Health, Labour and Welfare has granted approval to Genmab's Epkinly (epcoritamab) for treating individuals with relapsed or refractory (R/R) follicular lymphoma who have undergone at least two prior therapies.

Nona Biosciences partners with UAB to advance B Cell research

Biotechnology company Nona Biosciences has entered into a licensing agreement with the University of Alabama at Birmingham (UAB) to advance its B cell development research.

Perceive Pharma secures $15m to advance neuroprotective therapeutic development

Perceive Pharma has secured $15m in a Series A funding round to expedite neuroprotective therapeutic development in glaucoma and other indications.

SpringWorks Therapeutics selects Onco360 as pharmacy partner for Gomekli

SpringWorks Therapeutics has selected Onco360 as national specialty pharmacy partner for Gomekli (mirdametinib).

Conduit and Charles River to evaluate AZD1656 in SLE model

Conduit Pharmaceuticals has announced a partnership with Charles River Laboratories to assess AZD1656 as well as its derivatives in a Systemic Lupus Erythematosus (SLE) model.