Sierra Oncology Inc. plans an NDA in the second quarter of this year for momelotinib (MMB), thanks to data from the phase III Momentum study with the drug in myelofibrosis (MF) patients who are symptomatic and anemic after treatment with an approved JAK inhibitor. Momentum, which pitted momelotinib against the androgen danazol, met all of its primary and key secondary endpoints. MMB inhibits JAK1/2 and ACVR1/ALK2. Shares of San Mateo, Calif.-based Sierra (NASDAQ:SRRA) closed Jan. 25 at $22.68, up $7.17, or 46%.
Having unveiled more data from the ongoing, global phase III Gener8-1 study with Roctavian (valoctocogene roxaparvovec, also known as valrox), Biomarin Pharmaceutical Inc. remains on track to file a regulatory submission with the FDA in the second quarter of this year for the gene therapy to treat adults with severe hemophilia A. The EMA is already reviewing a marketing authorization application.
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology annual meeting, including: Century, Forma.
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology annual meeting, including: Beyondspring, Coimmune, Geron, JW, Novartis, Oncolytic, Oncternal, Oric, Oryzon, Ose, Pfizer, Poseida, Precigen, Rheos, Roche, Rocket, Sangamo, Sanofi, Seagen, Secura, Sierra, Syndax, Talaris, Tessa, TG, Viracta, Wugen, Xencor.
DUBLIN – Fans of “His Dark Materials” and the “Book of Dust,” Philip Pullman’s series of fantasy novels set in Oxford, U.K. and more remote corners of the earth, are familiar with alethiometers. In the hands of a highly select number of characters, these complex, compass-like devices can interrogate a mysterious substance called “dust” – an elementary particle associated with consciousness – and provide trusted answers to the most crucial questions.
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology annual meeting, including: 2seventy, Actinium, Agios, Allogene, Antegene, Apellis, Aptose, Ascentage, Atar, Bantam, Bioinvent, Daiichi, Harpoon, Iaso, Innocare, Innovent, Janssen, Karyopharm, Keros, Kymera, Lantern, Legend, Magenta, Mereo, Mustang, Nektar, Neximmune, Nextcure, Nkarta.
Two trials presented at the annual meeting of the American Society of Hematology (ASH) showed that treatment with the antithrombin inhibitor fitusiran reduced the bleeding rate in patients with severe hemophilia by roughly 90%, regardless of whether they had type A or B, and whether they had developed antibodies to recombinant clotting factors.
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology annual meeting, including: Actinium, Adagene, Affimed, Agios, Allogene, Annexon, Aprea, Arcellx, Astrazeneca, Autolus, Beigene, Editas, Emmaus, Epizyme, Equillium, Fate, Freeline, Gamida, GBT, Genentech, Glycomimetics, GSK, Hutchmed, I-Mab, Imara, Kite, Kura, Sutro.
PERTH, Australia – In the second multi-billion-dollar pharma merger this week, CSL Ltd. has announced plans to buy Vifor Pharma Ltd. for an equity value of $11.7 billion. It’s also the second largest biopharma merger of 2021, a whisker above Merck & Co Inc.’s $11.5 billion acquisition of Acceleron Pharma Inc. in November, although way off Astrazeneca plc’s $39 billion buy of Alexion Pharmaceuticals Inc. in July.
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