Tag: FDA
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FDA Fast-Tracks Antibody for Inhalational Anthrax Treatment
Emergent BioSolutions Inc. in Rockville, Maryland says that its program for developing AVP-21D9, an antibody for the treatment of inhalational anthrax, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Anthrax commonly affects hoofed animals such as sheep and goats, but also humans who come into contact with the infected…
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Panel: Make Cigarettes Non-Addictive
The passage of the Family Smoking Prevention and Tobacco Control Act in 2009 gave the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products, and a panel of eight health policy experts recommends that FDA use that authority to mandate the reduction of nicotine levels in cigarettes to non-addictive levels. The panel published…
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Stem Cell Source Collection Gets Review Board OK
International Stem Cell Corporation (ISCO) in Oceanside, California, said today that its unfertilized egg collection and activation protocol have received the approval of an Institutional Review Board (IRB). IRB review and approval is a Federal requirement for studies with human subjects, and ensures to protect subjects from unnecessary medical risks. ISCO’s work has resulted in…
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Trial Shows Positive Results for Hodgkin Lymphoma Drug
Seattle Genetics Inc., a biotech company in Bothell, Washington, and and Millennium, a developer of cancer drugs in Cambridge, Massachusetts, today released positive top-line results from a trial of their drug brentuximab vedotin. The drug is antibody-drug conjugate that works like an antibody carrying molecules toxic to cancer cells, targeted to CD30, a marker for…
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FDA Gives Muscular Dystrophy Therapy Orphan Drug Status
Amsterdam Molecular Therapeutics (AMT), a biotechnology company in the Netherlands doing work in human gene therapy, said today that the U.S. Food and Drug Administration (FDA) has designated its gene therapy for Duchenne muscular dystrophy (DMD) as an orphan drug. In October 2009, a committee the European Medicines Agency also granted the therapy, known as…
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FDA Approves Novartis Multiple Sclerosis Drug
Novartis, an international pharmaceutical company, said today that the U.S. Food and Drug Administration (FDA) approved its drug Gilenya, an oral multiple sclerosis (MS) treatment. Gilenya (fingolimod) is the first drug available in the U.S. that treats relapsing forms of multiple sclerosis, the most common forms of the disease. Novartis says the Gilenya approval was…
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Coronary Stent Gets FDA Approval
Medical device developer Medtronic Inc. in Minneapolis, Minnesota, said today the U.S. Food and Drug Administration (FDA) approved its Integrity coronary stent system for use in the United States. The stent system already received the CE (Conformité Européene) mark in February and is currently available in approximately 100 countries outside the United States. The company…
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Clinical Study Data Published on Cortical Bone Substitute
Orthovita Inc., a developer of medical implants in Malvern, Pennsylvania, reports today that the journal Spine published data from studies of its product Cortoss, an injectable polymer composite that mimics cortical bone. The paper reports on two pilot studies of Cortoss to treat vertebral compression fractures or VCF (paid subscription required}. The paper says Cortoss…
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Contract Awarded for Radiation Countermeasure Drug
Cleveland BioLabs Inc., a drug development company in Buffalo, New York, received a contract from the U.S. Department of Defense (DoD) to develop and stockpile its drug CBLB502 as a medical radiation countermeasure. The initial contract provides $14.8 million for advanced development of the drug, with later options worth $30 million for purchase of doses.…
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iPhone App Reports Drug Safety, Adverse Events Info
Researchers at Children’s Hospital Boston in Massachusetts and University of North Carolina at Chapel Hill have developed MedWatcher, a new iPhone application that tracks the latest drug safety updates and alerts from the Food and Drug Administration (FDA) and the news media. It also lets users report information about drug side effects and view reports…