Category: Regulations
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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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NIST Develops Standard Cigarette for Fire Safety Testing
Makers of home furnishings need to test their products for fire resistance, and the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland has come up with a tool to help: a cigarette. A responsibility of NIST, an agency of the U.S. Department of Commerce, is development of standard reference materials (SRMs) for industrial…
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First Wave Energy Device Connected to Power Grid
Ocean Power Technologies (OPT) in Pennington, New Jersey, says it has completed the first-ever grid connection of a wave energy device in the United States at Marine Corps Base Hawaii on Oahu. The grid connection uses OPT’s PowerBuoy systems to produce what the company calls utility-grade, renewable energy that can be delivered compliant with national…
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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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NRC Report: Biometric Technology “Inherently Fallible”
Biometric systems — designed to recognize individuals based on biological and behavioral traits such as fingerprints, palm prints, or voice or face recognition — are “inherently fallible,” says a new report by the National Research Council (NRC). In addition, says the report, no single biological and behavioral trait has been identified that is stable and…
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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…