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llllllllll Enspryng (satralizumab) / RocheChugai Launches Enspryng (Satralizumab) Subcutaneous Injection 120 mg Syringe, the pH-Dependent Binding Humanized anti-IL-6 Receptor Monoclonal Antibody (Chugai Press Release) - Aug 26, 2020 - "Chugai Pharmaceutical Co., Ltd....announced the launch of Enspryng® Subcutaneous Injection 120 mg Syringe [generic name: satralizumab (genetical recombination)] (hereafter, Enspryng) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD) [including neuromyelitis optica (NMO)]....In Japan, the product received manufacturing and marketing approval on June 29, 2020, and was listed on the National Health Insurance (NHI) reimbursement price list today....'We are confident that Enspryng will contribute to the treatment of a wide range of people from adults to children both in terms of relapse prevention and convenience.'"llllllllll asciminib (ABL001) / Novartis; Bosulif (bosutinib) / PfizerNovartis investigational novel STAMP inhibitor asciminib (ABL001) meets primary endpoint of Phase III chronic myeloid leukemia study (GlobeNewswire) - Aug 26, 2020 - P3, N=234; NCT03106779; Sponsor: Novartis Pharmaceuticals; "Novartis announced today that, at primary analysis, the Phase III ASCEMBL study met its primary endpoint of statistically significant superiority in major molecular response (MMR) rate at 24 weeks for asciminib (ABL001) vs. bosutinib...in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine-kinase inhibitors (TKIs)...Data from the ASCEMBL trial will be submitted for presentation at an upcoming medical meeting, and results will be shared with regulatory authorities. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for asciminib."llllllllll CT-P59 / CelltrionCelltrion Receives Korean MFDS Approval to Initiate Phase I Trial of COVID-19 Antiviral Antibody Treatment Candidate, CT-P59, in Patients (Businesswire) - Aug 26, 2020 - "Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase I clinical trial of CT-P59....Celltrion has initiated enrolment of patients with mild symptoms of SARS-CoV-2 infection....Celltrion anticipates global pivotal study results from the Phase II and III trials in patients with mild symptoms, the Phase III trial in patients with moderate-to-severe COVID-19, and the prevention clinical trial, by the end of the year."llllllllll Vafseo (vadadustat) / Akebia Therap, Otsuka, Mitsubishi TanabeAkebia Therapeutics Announces First Commercial Launch of VAFSEO (vadadustat tablets), a New Oral Treatment for Anemia Due to Chronic Kidney Disease, in Japan (PRNewswire) - Aug 26, 2020 - "Akebia...announced that vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is now commercially available in Japan as a treatment for anemia due to chronic kidney disease (CKD) under the trade name VAFSEO™....The starting dose for VAFSEO is indicated at 300 mg with a maximum dose indicated at 600 mg."llllllllll stenoparib (2X-121) / Oncology VenturePress Release Oncology Venture’s Novel PARP Inhibitor Stenoparib (formerly 2X-121) Shows Anti-Viral Activity Against Coronavirus in Pre-Clinical Studies (GlobeNewswire) - Aug 26, 2020 - "Stenoparib is currently being evaluated for the treatment of advanced ovarian cancer in a DRP®-guided Phase 2 clinical trial at the Dana-Farber Cancer Institute (Boston, MA U.S.A.) using a DRP® companion diagnostic to guide patient enrollment and improve therapeutic outcome...the Phase 2 study (Denmark) of Stenoparib in heavily pretreated breast cancer (mBC) patients, that was initiated in 2018, will be terminated...the Company expects enrollment to restart in its Phase 2 ovarian cancer trial for Stenoparib...by late Q4 2020...the clinical validation of the DRP® companion diagnostic for Stenoparib has been published in the British Journal of Cancer..."
