With a packed pipeline of drug candidates targeting multiple markers of cancer, Bayer AG signed on for a new project, this time going after the KRAS pathway with a global deal that could bring Kumquat Biosciences Inc. up to $1.3 billion in payments. Read More
Insmed Inc. CEO William Lewis said that offering two doses of Brinsupri (brensocatib) will complicate payer coverage “not at all, just the opposite. It’s going to give the flexibility to physicians to choose how they want to engage with their patients, wrestle with whatever issues may be in their minds related to safety [and] what have you.” The U.S. FDA approved Insmed’s first-in-class dipeptidyl peptidase 1 inhibitor, Brinsupri, given in 10-mg and 25-mg tablets as a once-daily treatment for noncystic fibrosis bronchiectasis in adults and children 12 and older. Read More
Fosun Pharmaceutical Co. Ltd. subsidiary Fosun Pharma Industrial is out-licensing its phase II dipeptidyl peptidase 1 inhibitor, XH-S004, to newco Expedition Therapeutics Inc. in a deal worth up to $645 million. Under terms of the deal, Expedition gains global rights to rights to develop, manufacture and commercialize XH-S004, except in mainland China, Hong Kong and Macau. Read More
Novartis AG’s monoclonal antibody, ianalumab, has notched back-to-back wins, one in treating Sjögren’s disease and the other for primary immune thrombocytopenia (ITP). In Sjögren’s, which has no U.S. FDA-approved treatment, the phase III Neptunus-1 and Neptunus-2 studies are the first phase III trials to prompt statically significant reductions in adults with the autoimmune disease. In ITP, a disease that has yet to see a cure, top-line data of a phase III study of ianalumab combined with eltrombopag stretched to the time to treatment failure compared to placebo, the primary endpoint showing the maintenance of safe platelet levels. Read More
The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions. Read More
Korea Disease Control and Prevention Agency (KDCA) secured 5.3 million doses of COVID-19 vaccines made by Pfizer Inc./Biontech SE and Moderna Inc., officially including the mRNA-based vaccines in the country’s national immunization program on Aug. 5. Read More
Experimental drugs that directly inhibit the NSD2 enzyme have shown potential as an effective strategy against hard-to-treat cancers, such as lung and pancreatic tumors driven by KRAS mutations. The therapeutic mechanism involves reversing a histone H3 methylation that promotes open chromatin and the expression of oncogenes. Read More
Biopharmas raising money in public or private financings, including: 180 Life Sciences, Aditxt, Entero, Equillium, Ligand, Longeveron, Ocugen, Xortx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Eli Lilly, Humacyte, Sitryx, Turnstone, Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arvinas, Bluebird, Boehringer, GSK, Kalvista, Nrx, Pfizer, Pharmather. Read More
