Drug Manufacturing

FDA clears PDS Biotechnology’s Versamune MUC1 combo for mCRC

The US Food and Drug Administration (FDA) has granted clearance for PDS Biotechnology's investigational new drug (IND) application to assess Versamune MUC1 plus PDS01ADC for the treatment of unresectable, metastatic colorectal carcinoma (mCRC).

LGM Pharma to expand manufacturing capabilities with $6m investment

LGM Pharma has announced more than $6m investment to expand its manufacturing facility in Rosenberg in the US state of Texas.

Aprea and MD Anderson sign agreement for APR-1051

Aprea Therapeutics has signed a material transfer agreement (MTA) with MD Anderson Cancer Center to explore APR-1051 for head and neck squamous cell carcinoma (HNSCC).

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.