BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. — BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of tislelizumab as a treatment for...
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SHANGHAI, China — Belief BioMed Group (BBM), an industry-leading biotech company focusing on innovative gene therapies, announced the completion of first subject dosing in its registrational clinical trial (CTR20233400) of BBM-H803, a gene therapy for hemophilia A, independently developed and produced by Belief BioMed. BBM-H803 is Belief BioMed’s first gene...
Phase 2 results provide a clinically meaningful reduction in pulmonary vascular resistance; Company intends to design a multi-dose Phase 2b trial Treatment was safe and well-tolerated, with no treatment-emergent adverse events observed during the acute hemodynamic dose-escalation phase of the study WARREN – Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or...
HAYWARD, Calif. – Benitec Biopharma Inc. (NASDAQ: BNTC), a development-stage biotechnology company focused on the advancement of novel genetic medicines, today announced significant progress regarding the regulatory interactions in Europe required to support advancement of the BB-301 development program towards the Phase 1b/2a clinical study in 2022. Benitec also confirmed the scheduling of an...
HAYWARD, Calif. — Benitec Biopharma Inc. (NASDAQ: BNTC), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (ddRNAi) platform, today announced it will host a virtual R&D Day, on Thursday, April 18, 2024 from 9:00 AM to 11:00 AM...
BERGEN, Norway — BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced that a poster presentation detailing additional data from a Phase II trial of bemcentinib in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in second line Non-Small Cell...
BerGenBio has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for bemcentinib in combination with an anti-PD-(L)1 agent for the treatment of patients with AXL-positive advanced/metastatic non-small cell lung cancer (NSCLC). The FDA’s decision represents the first recognition by a regulator of AXL-positive patients...
INDIANAPOLIS — A beta blocker typically used to treat heart problems, hemangioma, migraines and anxiety could be a new therapeutic for patients with sickle cell disease. Researchers led by Ankit A. Desai, MD, associate professor of medicine at the Krannert Cardiovascular Research Center (KCVRC) at Indiana University School of Medicine, have been...
SAN FRANCISCO, Calif. — Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic...
HAMILTON, Bermuda — Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. and a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced that the Phase 1 Study evaluating UNO in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and...