Tag: FDA
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FDA Funds Organ-on-Chip to Test Radiation Disease Treatments
The U.S. Food and Drug Administration awarded a contract to a Harvard University lab for simulated organ devices to test radiation disease countermeasures. The $5.6 million award will fund the work of Harvard’s Wyss Institute for Biologically Inspired Engineering from FDA’s research and development program on regulatory science and medical countermeasures initiative. Wyss Institute researchers,…
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FDA Approves Shipping of GSK Four-Strain Flu Vaccine
The global pharmaceutical company GlaxoSmithKline says the U.S. Food and Drug Administration gave its approval to ship the company’s vaccine covering four potential virus strains for the 2013-2014 influenza season. GSK says this year will be the first that vaccines will be available to protect against more than three strains of flu. FDA approved GlaxoSmithKline’s Fluarix…
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Actelion to Acquire Developer of Rare Cancer Treatment
Actelion Ltd, a biopharmaceutical company based in Switzerland, acquired Ceptaris Therapeutics Inc., a specialty pharmaceutical developer in Malvern, Pennsylvania, in a deal with a potential value of at least $250 million. The acquisition, however, depends on the U.S. Food and Drug Administration approving Ceptaris’s only current product, a topical treatment for symptoms from a rare…
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Safety Concerns Halt Celgene Leukemia Drug Trial
The biopharmaceutical company Celgene in Summitt, New Jersey is stopping a late-stage clinical trial of its cancer drug lenalidomide to treat chronic lymphocytic leukemia due to the higher death rate of patients taking the drug. Lenalidomide is a small-molecule compound that regulates the immune system and marketed by Celgene under the brand name Revlimid. The…
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Food Industry Establishes Traceability Research Center
The Institute of Food Technologists (IFT) in Chicago unveiled its Global Food Traceability Center to conduct research and develop best practices to identify sources of health problems related to food products. The organization says there currently is no single group that brings together all industry stakeholders to collaborate on finding solutions to these problems. The…
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Roche Advanced Skin Cancer Drug Approved in Europe
The global pharmaceutical company Roche says its drug vismodegib, marketed under the name Erivedge, received conditional approval in Europe as a treatment for adults with advanced cases of basal cell carcinoma, a form of skin cancer. Approval for the the drug, taken once a day in capsule form, is limited to cases of basal cell carcinoma that metastasize,…
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US, Europe Regulators Give Alzheimer’s Model Positive Marks
A computer model simulating the progression of Alzheimer’s disease in clinical trials received favorable comments from U.S. and European health regulatory agencies. The Disease Model of Mild and Moderate Alzheimer’s Disease was developed by the Coalition Against Major Diseases, an initiative of the Critical Path Institute in Tucson, Arizona. The model, says the institute, simulates…
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FDA Approves Maintenance Drug to Treat Opioid Dependence
Orexo AB, a pharmaceutical company in Uppsala, Sweden says it received approval from the U.S. Food and Drug Administration to market in the U.S. its drug Zubsolv for the treatment of opioid dependence, such as from prescription pain killers. FDA, says the company, approved the drug as a maintenance treatment — a substitute for addictive…
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FDA Giving Roche Leukemia Antibody Priority Review
An engineered antibody to treat chronic lymphocytic leukemia developed by the pharmaceutical company Roche is receiving priority review from the U.S. Food and Drug Administration, which sets a goal of six months to complete its evaluation. The therapy is obinutuzumab, code-named GA101, which in May, FDA designated as a “breakthrough” that expedites the review process…
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Blood Stem Cell Transplants Tested as Sickle Cell Therapy
Researchers at University of California in Los Angeles, University of Southern California, and hospitals in California tested a technique that harnesses a patient’s own blood-producing stem cells as a potential treatment for sickle cell disease. The team led by UCLA’s Donald Kohn published its findings today online in the Journal of Clinical Investigation, under a…