Dr. Reddy's proposed biosimilar application for Rituximab has been accepted by the FDA, EMA, and MHRA. DRL_RI is being developed as a biosimilar of Rituxan®/MabThera® (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. Rituxan® / MabThera® is approved for various indications including for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. The submission of its dossier in April 2023 was based on a comprehensive data package that demonstrated similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU and U.S. reference products.
DTx Pharma, a preclinical stage biotechnology company addressing the delivery challenges of oligonucleotide therapeutics with its Fatty Acid Ligand Conjugated OligoNucleotide (FALCON™) platform, has been acquired by Novartis. DTx Pharma's lead program is currently in preclinical development, with FDA Orphan Drug Designation, for the treatment of Charcot-Marie-Tooth Disease Type 1A (CMT1A). CMT1A is a progressive, neuromuscular, autosomal-dominant disease that can lead to life-long loss of muscle function and disability. Under the terms of the agreement, Novartis will make an upfront payment of $500M and additional payments of up to $500M upon completion of pre-specified milestones.
The FDA approved Beyfortus for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus is a monoclonal antibody with activity against RSV. Beyfortus, was jointly developed by Sanofi and AstraZeneca
Biosynth, a supplier of raw materials to the life science industry, has acquired Celares, a developer and manufacturer of conjugate vaccines, bioconjugate drugs, activated PEGs, and polymer-based drug delivery excipients. The acquisition will strengthen Biosynth’s exposure to the fast-growing conjugate vaccines and bioconjugate drugs market, expand its capabilities and enabling the company to offer the bioconjugation of antibodies, antigens, and peptides to its existing pharma and diagnostics customer base.
Endo International announced that its Par Sterile Products business began shipping bivalirudin injection in a ready-to-use single-use vial. It is the only ready-to-use liquid format of bivalirudin on the market in the U.S. The product is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots. It is used to prevent blood clots in people with severe chest pain or other conditions who are undergoing an angioplasty procedure.