WINNIPEG, Canada – Medicure Inc. (TSXV:MPH)(OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today announced that the FDA provides complete approval to enroll patients in its pivotal Phase 3 clinical trial to evaluate the...
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WINNIPEG, Canada – Medicure Inc. (TSXV:MPH)(OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, announced today that through its subsidiary, Medicure International Inc., the U.S. Food and Drug Administration (FDA) has granted Fast Track designation...
SAN FRANCISCO — Medivation, Inc. (Nasdaq: MDVN) today announced the completion of patient enrollment in the CONNECTION study, a six-month, confirmatory, pivotal Phase 3 trial of the investigational drug dimebon in patients with mild-to-moderate Alzheimer’s disease. The international, double-blind, placebo-controlled, pivotal Phase 3 study enrolled 598 patients, exceeding the enrollment...
LOS ANGELES — MEDomics, LLC (www.medomics.com) announces an innovative test for early diagnosis of mitochondrial diseases, a group of disorders that can result in neurological dysfunction, muscle weakness, gastrointestinal symptoms, migraine headaches, blindness, deafness, and diabetes. The MEDomics mitochondrial genome test, MitoDx(TM), uses the revolutionary NextGen sequencing technology to detect...
SAN DIEGO – MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, and Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, today announced...
SAN DIEGO & BEDMINSTER, N.J. – MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company that utilizes the latest biotechnology to discover and...
WASHINGTON – The Melanoma Research Alliance (MRA) released the following statements from MRA Chief Science Officer Marc Hurlbert, PhD and MRA President & CEO Michael Kaplan on the Food & Drug Administration approval of tebentafusp, the first drug for treating metastatic uveal melanoma: “This approval represents a new day for...
LAWRENCEVILLE, N.J. — IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab in...
POMEZIA, Italy – The Menarini Group announced today that additional data have been generated on SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, as part of the DIAMOND-01 trial. The results will be presented at both the upcoming American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) Virtual Congresses. DIAMOND-01...
FLORENCE, Italy – The Menarini Group announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to SEL24/MEN1703 for the treatment of Acute Myeloid Leukemia (AML). SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor, in-licensed by Menarini from Ryvu Therapeutics, and currently investigated in...