Tag: FDA
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Fibrocell Science Licenses Stem Cell Technology from UCLA
17 June 2014. The biotechnology company Fibrocell Science Inc. in Exton, Pennsylvania is licensing stem cell discoveries from University of California in Los Angeles for personalized treatments of serious bone and connective tissue conditions. Financial aspects of the licensing deal were not disclosed. Fibrocell Science develops treatments for rare and serious conditions affecting bones, connective…
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FDA Grants Experimental Leukemia Drug Orphan Status
16 June 2014. Agios Pharmaceuticals Inc. in Cambridge, Massachusetts says the U.S. Food and Drug Administration designated its therapy for acute myelogenous leukemia an orphan drug, qualifying it for tax incentives and other benefits. The orphan drug status comes at the same time of new findings reported from an early clinical trial of the drug,…
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Trial Shows Single-Dose Antibiotic Effective with MRSA
5 June 2014. Researchers at Duke University in Durham, North Carolina and the Medicines Company in Parsippany, New Jersey show in a late-stage clinical trial that a single dose of the antibiotic oritavancin works as well in treating acute bacterial skin infections, including those from methicillin-resistant Staphylococcus aureus (MRSA) bacteria, as the current standard of care…
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Remote Heart Failure Monitoring Device Approved by FDA
29 May 2014. The U.S. Food and Drug Administration yesterday approved an implanted device that measures pulmonary artery pressure and heart rate of patients with moderate heart failure who were hospitalized in the previous year. The device, the CardioMEMS HF System, is made by CardioMEMS Inc. in Atlanta. St. Jude Medical, a medical device manufacturer…
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Genetic Blood Transfusion Diagnostic Approved by FDA
23 May 2014. The U.S. Food and Drug Administration approved a molecular diagnostic test to help determine genetic compatibility for blood transfusions, a particular need for people requiring frequent transfusions. The PreciseType HEA Molecular BeadChip Test is made by BioArray Solutions, a subsidiary of Immucor, a developer of diagnostics for transplants and transfusions in Norcross,…
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Engineered Antibody Given FDA Breakthrough Tag for Myeloma
19 May 2014. Bristol-Myers Squibb in New York says its engineered antibody elotuzumab received a breakthrough therapy designation from the U.S. Food and Drug Administration to treat multiple myeloma, when used with two other cancer drugs. Elotuzumab is being developed by Bristol-Myers Squibb and AbbVie, in North Chicago, Illinois. Multiple myeloma is a progressive cancer…
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FDA Clears Asthma/COPD Mobile Reporting, Analytic System
6 May 2014. Propeller Health in Madison, Wisconsin says the U.S. Food and Drug Administration cleared the latest version of its mobile-device system to record and track maintenance therapy for patients with respiratory diseases, such as asthma and chronic obstructive pulmonary disease or COPD. The new version of the system cleared by the FDA, says…
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FDA Approves Intermediate ALS Stem Cell Clinical Trial
28 April 2014. BrainStorm Cell Therapeutics, in New York and Israel, says the U.S. Food and Drug Administration approved its beginning an intermediate stage clinical trial of a stem cell-based therapy for amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease. The trial will test for safety and tolerability of the company’s treatments…
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FDA Proposes Accelerated Medical Device Approval Process
23 April 2014. The U.S. Food and Drug Administration proposed yesterday a change in its approval processes for devices that meet unfilled treatment or diagnostic needs of patients with serious medical conditions. The Expedited Access Pre-market Approval Application, says the agency, is designed to speed not only the approval of new medical devices, but also…
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Blood Glucose Control Drug Approved for Type 2 Diabetes
15 April 2014. The U.S. Food and Drug Administration approved the drug albiglutide to help adults with type 2 diabetes control their blood glucose levels. Albiglutide is marketed in the U.S. under the brand name by Tanzeum by the global pharmaceutical company GlaxoSmithKline. Diabetes is a chronic condition where the pancreas does not create enough…