Pharmaceuticals, Biotechnology and Life Sciences
The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Approval of Tyruko by the European Medicines Agency is also expected imminently.
BridgeBio Pharma announced today that detailed Phase 3 results from ATTRibute-CM, its study of acoramidis in transthyretin amyloid cardiomyopathy, or…
AiCuris Anti-infective Cures AG has received milestone payments in the amount of EUR €30 million from its licensing partner MSD (Merck) after the U.S. FDA’s approval for first-in-class antiviral agent PREVYMIS® in a new indication – the prophylaxis of CMV disease after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients.
Rentschler Biopharma, a leading global contract development and manufacturing organisation (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), announces a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of cell and gene therapies, and Refeyn Ltd., the Oxford based mass photometry pioneer.
Redx has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for the potential treatment of Idiopathic Pulmonary Fibrosis (IPF) for Zelasudil, which is currently in a Phase 2a clinical study for IPF, with topline data expected in Q1 2024.
The European Commission (EC) has approved Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection
Genethon, a pioneer and leader in gene therapy research and development for rare genetic diseases, announced today positive Phase 1/2 clinical trial results of its gene therapy, GNT-0003, for Crigler-Najjar syndrome were published in The New England Journal of Medicine.
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., has reached a deferred prosecution agreement (DPA) with the U.S. Department of Justice (DOJ) to settle the criminal price-fixing charges brought against Teva in 2020.
ViGeneron GmbH, a Germany-based gene therapy company, has received from the European Medicines Agency (EMA) an approval for its Clinical Trial Application (CTA) for VG901, a potentially transformative gene therapy to treat CNGA1-associated Retinitis Pigmentosa (RP), an ocular disorder currently lacking approved therapies.
MGC Pharmaceuticals, a European based specialising in the production and development of plant derived medicines, announced positive pre-clinical trial results from the recently completed Pre-clinical Chronic Toxicology Evaluation of 14 days oral dose of CimetrA.