WASHINGTON, Dec. 1, 2020 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Hetlioz (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS). SMS is a rare neurodevelopmental disorder, a defining
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KENILWORTH, N.J.–(BUSINESS WIRE) November 16, 2020 — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced a collaboration with the Bill & Melinda Gates Foundation (the foundation) where the foundation is committing to provide funding to support a pivotal Phase 3 study investigating a once-monthly oral pre-exposure prophylaxis (PrEP)1
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KIRKLAND, QUEBEC, CANADA and MAINZ, GERMANY, October 9, 2020 — Pfizer Canada and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to Health Canada for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19. The rolling submission has been accepted under the Minister of Health’s Interim Order allowing companies to submit safety and efficacy data
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GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with
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The U.S. opioid epidemic is still raging—it’s particularly pronounced in low-income areas and in those where people lack access to health care services, which includes cities in Michigan and across the Rust Belt. But the effectiveness of efforts to provide treatment and recovery options to those who need it most—that is, in locations with the
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There is a strong association between the number of fracture-associated drugs (FADs) older patients receive and their risk of sustaining a broken bone, according to a new Dartmouth study published in JAMA Network Open. In recent decades, the use of prescription medications has increased dramatically in the U.S. due to factors such as improvements in
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A combination of drugs that affect mitochondria—the power plants inside cells—may become the best weapons yet to fight acute myeloid leukemia, according to Rice University researchers. A study led by Rice bioscientist Natasha Kirienko and postdoctoral researcher Svetlana Panina found that mitocans, anti-cancer drugs that target mitochondria, are particularly adept at killing leukemia cells, especially
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Drug overdoses have driven the first significant reduction in US life expectancy since the AIDS epidemic in the 1990s, an official report published Wednesday showed. Americans have lost almost four months of longevity since 2014, the report by the Centers for Disease Control and Prevention (CDC) said. “This is the first big drop since 1993,
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(HealthDay)—Rituxan (rituximab) injection was granted the first approval for a drug to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in combination with glucocorticoids in children 2 years and older, the U.S. Food and Drug Administration announced Friday. The agency noted that pediatric patients with GPA, previously known as Wegener’s granulomatosis, and MPA have
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Lauren Tilmont didn’t believe it when her doctor told her a few years ago that he had a treatment that might allow her to eat peanuts, despite a lifelong allergy to them. “The first thing I told him was, “You’re crazy. That doesn’t happen,” ” said Tilmont, 25, of Rogers Park. She had been told
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