Approval came right on time for Repatha (evolocumab), Amgen Inc.'s proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, with a label that includes homozygous familial hypercholesterolemia (HoFH), "the most severely affected part of the this [FH] community, because they've inherited some sort of FH mutation from both parents," Katherine Wilemon, founder of the Familial Hypercholesterolemia (FH) Foundation, told BioWorld Today. Read More
Takeda Pharmaceutical Co. Ltd. and Nanotherapeutics Inc. have struck an agreement providing Takeda with expanded commercialization and technology rights to Nanotherapeutics' Vero cell technology, a manufacturing platform that's key to Takeda's flu vaccines and its aspirations to further develop its global vaccines business in other markets. Read More
Celltrion Inc. recently racked up its 62nd approval for Remsima, adding Australia to the growing list of countries where the infliximab biosimilar can be marketed. But biosimilar sponsors are finding that it's going to take more than a string of approvals to crack the blockbuster biologics market. Read More
Minerva Biotechnologies Inc., of Waltham, Mass., and ID Pharma Co. Ltd. (formerly Dnavec), of Ibaraki, Japan, said they signed an agreement granting Minerva worldwide rights to use and commercialize ID's non-integrating Sendai virus vectors together with Minerva's technology for generating induced pluripotent stem (iPS) cells. Read More
Corbus Pharmaceuticals Holdings Inc., of Norwood, Mass., said all of the outstanding warrants issued to investors in April through May last year were exercised during the call notice period, which expired Aug. 26. Read More
Oncolytics Biotech Inc., of Calgary, Alberta, said it plans to report updated results during the International Association for the Study of Lung Cancer 16th World Conference on Lung Cancer in Denver next monhth, including longer-term survival data, from the company's REO 016 phase II study of Reolysin (pelareorep) given intravenously with paclitaxel and carboplatin every three weeks for the treatment of non-small-cell lung cancer. Read More
