Drug Manufacturing

France 2030 funds 4MB’s knee osteoarthritis drug trial

4P-Pharma spin-off 4Moving Biotech (4MB) has received €7.6m ($8.3m) in funding from the France 2030 plan to expedite the clinical development of 4P004 for knee osteoarthritis, currently in a Phase IIa clinical trial.

FDA grants breakthrough therapy status for Amgen’s Uplizna to treat IgG4-RD

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Amgen’s humanised monoclonal antibody Uplizna (inebilizumab-cdon) to treat the adult population with immunoglobulin G4-related disease (IgG4-RD), an immune-mediated inflammatory condition that impacts several organs.

FDA clears Epicrispr’s application for FSHD treatment

The US Food and Drug Administration (FDA) has granted clearance for an investigational new drug (IND) application of Epicrispr Biotechnologies’ EPI-321, intended for treating genetic neuromuscular condition, facioscapulohumeral muscular dystrophy (FSHD).

EC grants orphan designation for Pharvaris’ deucrictibant drug

Pharvaris has secured orphan designation from the European Commission (EC) for deucrictibant, an investigational drug for treating bradykinin-mediated angioedema.

NeuroNOS secures funding for autism treatment development

As a part of a broader investment round, Beyond Air’s subsidiary NeuroNOS has received an initial equity financing of $2m from private investors, aimed at expediting the preclinical development of its small-molecule drug for paediatrics with autism.

Duke-NUS and NUS Medicine launch centre for metabolomics research

A collaborative effort between Duke-NUS Medical School and the National University of Singapore Yong Loo Lin School of Medicine (NUS Medicine) has led to the launch of the joint research centre named Systems Metabolomics Centre (SysMeC), aimed at metabolomics research.

FDA approves Novartis’ Fabhalta for C3 glomerulopathy treatment

The US Food and Drug Administration (FDA) has granted approval for Novartis’ Fabhalta (iptacopan), intended to minimise proteinuria in the adult population with C3 glomerulopathy (C3G).

Porton Advanced and Eureka to expedite T-cell therapy development

Contract development and manufacturing organisation (CDMO) Porton Advanced has announced a partnership with Eureka Therapeutics to expedite the worldwide clinical development of T-cell therapies.

Delpharm plans $140m investment to upgrade Boucherville facility in Canada

Contract development and manufacturing organisation (CDMO) Delpharm has announced plans to invest over C$200m ($140m) to modernise its Boucherville facility in Canada.