Industry News
Coronavirus disease 2019 (COVID-19) is an infectious disease, caused by severe acute respiratory syndrome coronavirus 2, which predominantly affects the lungs and, under certain circumstances, leads to an excessive or uncontrolled immune activation and cytokine response in alveolar structures. The pattern of pro-inflammatory cytokines induced in COVID-19 has similarities to those targeted in the treatment…
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Since early March, around 1,000 organisations supporting clinical trials as the sponsor, collaborator, or contract research organisation (CRO) have publically announced disruptions to planned and ongoing clinical trials in their press releases, Securities and Exchange Commission (SEC) filings, and clinical trial registries, as well as on social media. Companies have delayed the initiation of planned…
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AMBRIDGE, Mass., May 29, 2019 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has agreed to fund the NexoBrid® expanded access treatment (NEXT) protocol. The NEXT protocol is being conducted under…
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For more than 30 years, the FDA has supported patients’ access to investigational medical products for treatment, outside of participation in a clinical trial, when appropriate. The FDA remains deeply committed to this effort. Helping to facilitate access to promising medicines for patients with serious or immediately life-threatening diseases or conditions when no comparable or…
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Today, the U.S. Food and Drug Administration is warning patients and health care professionals of risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems. In the safety communication issued today, the agency noted that the use of unapproved or…
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New research from Johns Hopkins University has identified a variety of biomarkers that can be used to predict the onset of Alzheimer’s disease years before symptoms appear. The study presents nine measures, produced from several decades of data, that can signal the onset of the disease up to 30 years before cognitive decline becomes apparent.…
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The first medicine designed to prevent migraines was approved by the Food and Drug Administration on Thursday, ushering in what many experts believe will be a new era in treatment for people who suffer the most severe form of these headaches. The drug, Aimovig, made by Amgen and Novartis, is a monthly injection with a…
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ROCHESTER, Minn. — The drug eculizumab, a synthetic antibody that inhibits the inflammatory response, significantly reduced the risk of relapse with neuromyelitis optica spectrum disorder (NMOSD). This rare but severe autoimmune inflammatory disorder can cause blindness, paralysis and death. Mayo Clinic researchers and international collaborators report their findings in a randomized, double blind, placebo-controlled study…
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Researchers at the University of Alabama at Birmingham and the University of Kansas Cancer Center have identified four hallmarks of cancer metastasis — when cancer has spread to different parts of the body from where it started. Metastasis is believed to be the cause of up to 90 percent of cancer deaths. Continue Reading
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