AbbVie Inc. (NYSE: ABBV) and Landos Biopharma, Inc. (NASDAQ: LABP) have announced a landmark agreement, marking a strategic move in the biopharmaceutical sector focused on the development of novel treatments for autoimmune diseases. The definitive agreement outlines AbbVie’s acquisition of Landos, a clinical-stage biopharmaceutical company renowned for its innovative approach to creating oral therapeutics for […]
Dong-A ST, the South Korean pharmaceutical company, has received confirmation from the European Medicine Agency (EMA) of the acceptance of their Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara (ustekinumab). The MAA was submitted to the EMA by Accord, a subsidiary of Intas Pharmaceuticals, on June 23rd, and the agency accepted the submission […]
Zydus Lifesciences, along with its subsidiaries and affiliates, has achieved a significant milestone with the final approval from the US Food and Drug Administration (FDA) for Balsalazide Disodium Capsules USP, 750 mg (known as Colazal Capsules, 750 mg in the US market). Balsalazide Disodium is a medication primarily used to treat bowel diseases such as […]
Merck has agreed to acquire Prometheus Biosciences, a Nasdaq-listed clinical-stage biotechnology company, in an all-cash deal worth around $10.8 billion, in a move to bolster its immunology pipeline. The California-based Prometheus Biosciences is engaged in the discovery, development, and commercialization of therapeutic and companion diagnostic products for the treatment of immune-mediated diseases by using a […]
Roivant Sciences, a US healthcare company, and Pfizer have established a new Vant to develop and commercialize PF-06480605 (now RVT-3101) for inflammatory and fibrotic bowel diseases. Pfizer-developed RVT-3101 is a fully human monoclonal antibody targeting tumor necrosis factor-like ligand 1A (TL1A), which has been shown to modulate the place and harshness of inflammation and fibrosis […]
Alembic Pharmaceuticals said that it has secured final approval for its abbreviated new drug application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g from the US Food & Drug Administration (FDA). The approved product is the generic of Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals. It is indicated for the maintenance of remission of […]
Biocon Ltd. said that its subsidiary Biocon Biologics has signed an out-licensing agreement with Japanese pharma company Yoshindo Inc. for commercializing a couple of its pipeline biosimilar assets — bDenosumab and bUstekinumab in Japan. Ustekinumab is a biosimilar of the reference drug Stelara, which is a monoclonal antibody for the treatment of psoriasis, ulcerative colitis, […]
AzurRx BioPharma has signed a stock and cash deal worth $229 million to acquire Florida-based clinical-stage biotech company First Wave Bio. The consideration includes payments for certain development, regulatory and sales milestones. First Wave Bio specializes in developing gut-targeted, small molecule therapies for auto-immune inflammatory bowel diseases (IBD) and other serious disorders. The buyer – […]
Zydus Cadila said that it has secured final approval from the US Food and Drug Administration (FDA) to market Mesalamine Extended-Release Capsules in the strength of 0.375g. Mesalamine Extended-Release capsules are approved for the maintenance of remission of ulcerative colitis in adult patients. Zydus Cadila said that the ulcerative colitis drug will be manufactured at […]
Vedanta Biosciences, a clinical-stage microbiome company founded by PureTech Health, has raised $68 million in a Series D financing round led by affiliates of Magnetar Capital. The Cambridge-based company is using defined bacterial consortia manufactured from clonal cell banks for developing a new category of oral therapies for the treatment of immune-mediated diseases. Other participants […]