BOSTON–(BUSINESS WIRE)–Oct. 12, 2020– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the U.S. Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvz) 100 mg/mL formulation for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric (one month of age and
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PLYMOUTH MEETING, PA and CHICAGO, IL, October 13, 2020 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has approved Wakix (pitolisant) for the treatment
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Unapproved Chloroquine Phosphate Product Related Links: CONCLUSION: Prevalence of antibiotic use was high not only versus other hospitals in the region but globally including Africa, coupled with significant evidence of sub-optimal prescribing. Swift action is needed to improve future prescribing to reduce AMR. One or two areas should initially be targeted for quality improvement including
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CGMP/Finished Pharmaceuticals/Adulterated Related Links: CONCLUSION: Prevalence of antibiotic use was high not only versus other hospitals in the region but globally including Africa, coupled with significant evidence of sub-optimal prescribing. Swift action is needed to improve future prescribing to reduce AMR. One or two areas should initially be targeted for quality improvement including development of
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Unapproved New Animal Drug Products Related Links: CONCLUSION: Prevalence of antibiotic use was high not only versus other hospitals in the region but globally including Africa, coupled with significant evidence of sub-optimal prescribing. Swift action is needed to improve future prescribing to reduce AMR. One or two areas should initially be targeted for quality improvement
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Drug Supply Chain Security Act pilot project program and enhanced drug distribution security Related Links: CONCLUSION: Prevalence of antibiotic use was high not only versus other hospitals in the region but globally including Africa, coupled with significant evidence of sub-optimal prescribing. Swift action is needed to improve future prescribing to reduce AMR. One or two
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VEKLURY is for use in adult and pediatric patients 12 years and older weighing at least 40 kg (88 lbs) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. Related Links: Former New Jersey Gov. Chris Christie says he has been discharged from a New Jersey hospital after a week there following his announcement
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FDA collaborates with state officials in a variety of ways, including by sharing information about compounders who engage in poor practices that could put patients at risk, sharing information about complaints and adverse events, and sharing findings from inspections. Related Links: CONCLUSION: Prevalence of antibiotic use was high not only versus other hospitals in the
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Are antibiotic stewardship programs resilient enough to withstand pandemic-size challenges?Medscape Medical News Related Links: CONCLUSIONS: This single practice study showed total patient contact was similar over both sample periods, but most contact in 2020 was virtual. Further longitudinal multi-practice studies to confirm these findings and describe future consultation patterns are needed to inform general practice
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“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously,” said a pharmacology researcher at ID Week2020.Medscape Medical News Related Links: CONCLUSION: Prevalence of antibiotic use was high not only versus other hospitals in the region but globally including Africa,
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Stephen Hahn, MD, Commissioner of Food and Drugs, Remarks to the Intergovernmental Working Meeting on Drug Compounding, 10/27/2020 Related Links: CONCLUSION: Prevalence of antibiotic use was high not only versus other hospitals in the region but globally including Africa, coupled with significant evidence of sub-optimal prescribing. Swift action is needed to improve future prescribing to
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IHME researchers predict the potential number of lives saved from COVID-19 this winter based on different percentages of Americans following mask and social distancing recommendations.Medscape Medical News Related Links: Publication date: Available online 10 October 2020Source: American Journal of Kidney DiseasesAuthor(s): Shreeram Akilesh, Cynthia C. Nast, Michifumi Yamashita, Kammi Henriksen, Vivek Charu, Megan L. Troxell,
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Summary Company Announcement Date: October 24, 2020 FDA Publish Date: October 27, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk, eggs, and fish Company Name: Incredible Fish, Inc. Brand Name: Brand Name(s) Incredible Stone Crab Product Description: Product Description Incredible Stone Crab Mustard Sauce Company Announcement Incredible Fish, Inc.
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