Sangamo Therapeutics, a genomic medicine company, announced today that the United Kingdom’s (UK) Medicines Healthcare Products Regulatory Agency (MHRA) has granted authorization of the first-in-human clinical trial to evaluate a Chimeric Antigen Receptor Regulatory T Cell (CAR-Treg) therapy.
The Medicines Company announced detailed results from ORION-10, the second of three pivotal 18-month low-density lipoprotein cholesterol (LDL-C) lowering Phase 3 clinical studies of inclisiran, an investigational twice-yearly therapy to reduce LDL-C and the first and only cholesterol-lowering treatment in the siRNA (small-interfering RNA) class.
GlaxoSmithKline (GSK) said that its respiratory drug Nucala (mepolizumab) has succeeded in reducing flares in patients with hypereosinophilic syndrome (HES) in a phase 3 study.
Boehringer Ingelheim and Eli Lilly have commenced first ever trial to evaluate Jardiance (empagliflozin) in people hospitalised for acute heart failure who have been stabilised.
Roche said that part 2 of the SUNFISH trial assessing risdiplam for the treatment of Type 2 or 3 spinal muscular atrophy (SMA) in people aged 2-25 years has met its primary endpoint.
AstraZeneca today presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased hemoglobin (Hb) levels in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anemia from chronic kidney disease (CKD), respectively.
Takeda Pharmaceutical announced that results from the primary endpoint analysis of the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate (TAK-003) were published in the New England Journal of Medicine.
Axcella Health, a biotechnology company pioneering the research and development of novel multifactorial interventions to address dysregulated metabolism and support health, announced key milestones in the development of AXA4010, the company’s first investigational hematology product candidate.
Halozyme Therapeutics has discontinued the development of PEGylated recombinant human hyaluronidase (PEGPH20) after the investigational drug failed to meet the primary endpoint in a phase 3 trial in metastatic pancreas cancer.
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company has begun a Phase 1 clinical trial with BCX9250, an oral activin receptor-like kinase-2 (ALK-2) inhibitor discovered and developed by BioCryst for the treatment of fibrodysplasia ossificans progressiva (FOP).
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