Category: Regulations
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Drug-Related Hospitalizations Double for Age 45+
The number of hospital admissions for Americans age 45 and older from medication and drug-related conditions doubled between 1997 and 2008, according to a report released today by the Agency for Healthcare Research and Quality (AHRQ), in the U.S. Department of Health and Human Services. AHRQ defines medication and drug-related conditions to include effects of…
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European Approval Given for Cancer Pain Drug
BioDelivery Sciences International (BDSI), a drug delivery technology company in Raleigh, North Carolina, said today its drug BREAKYL received approval for marketing by the German review authorities. Meda, a Swedish pharmaceutical company, partnered with BDSI on the development of the drug. The approval of BREAKYL by Germany will apply to all Europe Commission countries, since…
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FDA Approves Anti-Coagulant Drug
The German pharmaceutical company Boehringer Ingelheim said the U.S. Food and Drug Administration (FDA) approved its drug Pradaxa (dabigatran etexilate), an oral-administered direct thrombin inhibitor to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF). The company says this is the first such approval of a new oral anti-coagulant in the U.S.…
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FDA Clearance Given for Catheter, Spinal Tap Devices
Mirador Biomedical, a medical device developer in Seattle, Washington, says that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for two of its products. A 510(k) clearance is required from FDA to market medical devices, where the manufacturers need to demonstrate the safety and effectiveness of the devices. The Compass Vascular Access,…
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Report: Loose Governance in Oil Company/University Agreements
The Center for American Progress (CAP), a progressive issues analysis organization in Washington, DC, reviewed 10 agreements between universities in the U.S. and oil companies where the companies offer to fund energy research, particularly in alternative fuels. The report finds several areas where the agreements have the potential to compromise academic freedom and limit the…
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FDA Approves Subcutaneous Delivery of Immunodeficiency Drug
Talecris Biotherapeutics, a biotechnology company in Research Triangle Park, North Carolina said today that the U.S. Food and Drug Administration (FDA) approved its Gamunex-C drug for subcutaneous administration in the treatment of primary immunodeficiency (PI). Subcutaneous administration — illustrated right — delivers the product under the skin into the subcutaneous tissue and intravenous administration is…
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More Research Urged on Marcellus Drilling Impact
The Academy of Natural Sciences in Philadelphia, Pennsylvania is calling for a comprehensive research plan that provides guidelines and an assessment tool for regulators and managers in order to minimize the environmental impact of Marcellus Shale gas drilling. Marcellus Shale is a deep geological formation along the east coast of the United States with an…
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FDA, NIH Award Grant to Study Adaptive Clinical Trial Design
Researchers from academia and business aim to improve the process for testing therapies and medical devices by investigating a new type of clinical trial called adaptive clinical trials. This kind of clinical study makes adjustments to the trial using information accumulated as patients are enrolled, with the goal of improving clinical trials’ efficiency as a…
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Anxiety/Depression Drug Trials Approved in France
Bionomics Limited, a drug development company in Adelaide, Australia, says the French national medical agency and ethics committee for Strasburg Hospital have approved the company’s request to conduct clinical trials for BNC210, Bionomics’ treatment of anxiety and depression now in development. The first clinical study will examine whether BNC210 reduces panic and anxiety symptoms induced…
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FDA Okays Myelodysplastic Syndromes Trial Protocol
Onconova Therapeutics Inc., a biotech company in Newtown, Pennsylvania, says it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of a Phase 3 clinical trial for the company’s drug Estybon. The drug is a monotherapy for patients with myelodysplastic syndromes (MDS), diseases affecting…