Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer.
Krystal Biotech Inc., (“Krystal”) (NASDAQ:KRYS), a gene therapy company developing topical and intradermal "off-the-shelf" treatments for rare dermatological diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KB103 for the treatment of dystrophic epidermolysis bullosa (DEB).
Australian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) is pleased to announce that the final patient has been treated in Cohort B of its Phase 1 clinical trial of CYP-001, its Cymerus™ mesenchymal stem cell (MSC) product candidate, in steroid-resistant acute graft-versus-host disease (GvHD)
Esperion (NASDAQ:ESPR), the Lipid Management Company focused on developing and commercializing complementary, convenient, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced positive top-line results from the third of five pivotal Phase 3 studies (Study 3 or 1002-046) expected to be reported this year.
INmune Bio, Inc., an immunotherapy company developing therapies that reprogram the patient’s innate immune system to treat cancer, today announced that it has initiated a Phase 1 clinical trial of its drug candidate INB03™ in patients with advanced solid tumors.
Bionomics Limited, a global, clinical stage biopharmaceutical company, recently announces that a Phase 2 clinical trial of its therapeutic candidate, BNC210, has commenced in elderly patients with agitation in the hospital setting. The first participant has been recruited into the trial.
Medidata announced that Memorial Sloan Kettering Cancer Center (MSK) is using Rave Omics with Biomarker Discovery for patients with pancreatic cancer, an example of the paradigm shift in clinical trials through the systematic capture of genomic data and the application of artificial intelligence algorithms.
WCG™ (WIRB-Copernicus Group®) Clinical Services Division, the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, recently announced the opening of the company’s new office in Tokyo, Japan.
Nabriva Therapeutics plc (NASDAQ:NBRV) today announced positive topline results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial, the second of two global, pivotal Phase 3 clinical trials of lefamulin.
MimiVax LLC, a clinical-stage biotechnology company developing immunotherapeutics and targeted therapies for cancer treatment, today announced positive interim results from a multicenter Phase II study of SurVaxM in patients with newly diagnosed glioblastoma (nGBM).
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