Tag: FDA
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Diabetes App Developer Files for FDA Pre-Market Clearance
LabStyle Innovations Corp. in Caesarea, Israel, developer of a mobile and cloud-based system for diabetes management, filed for pre-market notification of its system with the U.S. Food and Drug Administration. Pre-market notification, once granted by FDA, clears medical devices for marketing in the U.S. LabStyle Innovations created the Dario system that combines a small glucose…
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FDA Lifts Hold on Blood Cancer Therapy Clinical Trials
Cell Therapeutics Inc., a biopharmaceutical company in Seattle developing cancer treatments, says the U.S. Food and Drug Administration lifted a six-month hold on tests of its experimental drug tosedostat to treat blood-related cancers. The intermediate-stage clinical trial is testing the drug in elderly patients with newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic…
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NIH Funding Further Marburg Virus Therapy Development
BioCryst Pharmaceuticals Inc., a developer of drugs for infectious and rare diseases in Durham, North Carolina, says National Institutes of Health (NIH) is continuing its contract with the company to develop a treatment for Marburg virus, the cause of a rare but dangerous tropical disease. The contract extension, says BioCryst, is worth $2.5 million, increasing…
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FDA Approves Rare Congenital Blood Disease Treatment
The U.S. Food and Drug Administration yesterday approved a treatment for congenital factor XIII A-subunit deficiency, a rare blood clotting disorder, made by the pharmaceutical company Novo Nordisk, based in Denmark. Tretten, the medication’s brand name, is an engineered biologic designed to prevent bleeding in adults and children with the disorder. People with factor XIII…
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Bayer Acquires Cancer Drug Developer Algeta for $2.9B
The global pharmaceutical company Bayer Group based in Germany is buying the specialty drug company Algeta ASA in Oslo, Norway for NOK 17.6 billion (USD 2.9 billion). Algeta, developer of a radium-based drug to treat prostate cancer, says its board of directors approved the sale, subject to confirmation by shareholders. Bayer and Algeta collaborated on…
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Graphic Labels Reduce Smoking More Than First Thought
Public health researchers at University of Illinois in Chicago and University of Waterloo in Ontario, Canada found graphic warnings on cigarette packs can reduce smoking to a greater extent than the U.S. Food and Drug Administration estimated two years ago. The team led by Chicago’s Jidong Huang published its findings online earlier this month in…
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FDA Approves Sale of High-Throughput DNA Sequencing Systems
The U.S. Food and Drug Administration yesterday cleared for marketing high-throughput sequencing systems by Illumina Inc. in San Diego to analyze a person’s DNA. In a commentary on this approval in New England Journal of Medicine, FDA director Margaret Hamburg and National Institutes of Health director Francis Collins say, “Access to these data opens the…
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FDA Approves Leukemia Treatment, First Breakthrough Therapy
The U.S. Food and Drug Administration on Friday approved an antibody designed to treat chronic lymphocytic leukemia, when taken with chemotherapy. Obinutuzumabm — developed and marketed as the brand name Gazyva by the biotechnology company Genentech, a division of Roche in South San Francisco, California — is the first drug designated as a breakthrough therapy approved…
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Automated System Developed to Monitor Drug-Induced Comas
Engineers at Massachusetts Institute of Technology and medical researchers at Massachusetts General Hospital in Boston developed and tested in lab animals a system connecting the brain to a drug infusion device that automatically controls anesthesia drugs administered to patients in a drug-induced coma. The team led by MIT engineering professor Emery Brown, who is also…
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Many Large Clinical Trials Remain Unpublished
Medical researchers at University of North Carolina in Chapel Hill found some three in 10 clinical trials having 500 or more participants remain unpublished, with results from the vast majority of unpublished studies not made available on ClinicalTrials.gov, the U.S. government’s database. Findings from the team led by emergency medicine professor Timothy Platts-Mills were reported…