Drug Manufacturing

Relief and Renexxion terminate merger talks

Swiss biopharmaceutical company Relief Therapeutics has confirmed the termination of discussions with the US-based clinical-stage biotechnology company Renexxion regarding a potential merger.

CordenPharma announces $1bn investment in peptide development and production

CordenPharma has announced significant advancements in its growth strategy, with a strategic investment exceeding €1bn (approximately $1.05bn) in peptide development and manufacturing over the next three years.

FairJourney acquires Charles River’s San Francisco site

FairJourney Biologics has acquired the South San Francisco site from Charles River Laboratories International, supporting its technology portfolio and broadening its international presence with a biotechnology hub in the US.

FDA approves Celltrion’s biosimilars for various indications

The US Food and Drug Administration (FDA) has approved Celltrion’s Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), the biosimilars referencing Amgen’s Prolia and Xgeva, respectively.

EMA’s CHMP recommends marketing authorisation for Novartis’ Fabhalta

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Novartis' Fabhalta (iptacopan) to treat the adult population with C3 glomerulopathy (C3G).

FDA grants fast track status for Avobis’ AVB-114

The US Food and Drug Administration (FDA) has granted fast track designation for Avobis Bio’s lead therapeutic candidate, AVB-114, for treating Crohn's perianal fistulas.

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.