Pharmaceuticals, Biotechnology and Life Sciences
Datopotamab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Adtralza tralokinumab in a new pre-filled pen, following the European Commission (EU) decision on the 1st of September 2023. The pre-filled pen will be available in the UK for tralokinumab patients from early 2024.
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.
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.
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.
Mainz Biomed has reported half year results, in which the main point was expanding international commercialization for its colorectal cancer detenction test, ColoAlert, which in turn has seen revenues for the first six months of 2023 at $499 049, representing an increase of 108% compared to the first half of 2022.
BioNTech and US based OncoC4 today announced that the first patient with non-small cell lung cancer (NSCLC) has been treated in a pivotal Phase 3 trial evaluating the companies’ next-generation anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart). The trial is part of BioNTech’s strategy to initiate multiple pivotal trials in 2023 and 2024, the companies said in a press release Thursday.