Category: Regulations
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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…
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EU Approves New Rules for Lab Animals
Rules governing the use of animals in scientific experiments are the product of new EU legislation approved today by the European Parliament. The legislation aims for a better balance between animal welfare and the need for research into diseases. EU member states will have two years to comply with new rules that aim to scale…
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Phase 2 Clinical Trial Planned for Depression Drug
Rexahn Pharmaceuticals Inc., a clinical stage pharmaceutical company in Rockville, Maryland, submitted today a Phase 2b protocol to the U.S. Food and Drug Administration for the clinical study of Serdaxin, a drug that treats major depressive disorder. The company says Serdaxin may work as an enhancer of serotonin and dopamine in the brain. In Rexahn’s…
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Drug Companies Urged to Conserve Antibiotics to Fight Resistance
A new report recommends that pharmaceutical companies take a different approach to combating resistance to antibiotic drugs. An article published today in the journal Health Affairs suggests physicians, hospitals, and drug makers coordinate their practices to extend the effective lifetimes of antibiotics. The paper, by Aaron S. Kesselheim of Brigham and Women’s Hospital and Harvard…
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European Approval Sought for Daily HIV Treatment
Gilead Sciences Inc. of Foster City, California is seeking approval to market a combination of its Truvada drug with Tibotec Pharmaceuticals’ TMC278 as a single-dose daily treatment for HIV infection. If approved, the new single-tablet regimen would be only the second product that contains a complete antiretroviral treatment regimen in a single once-daily tablet, according…
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FDA Holding Workshop on Nanotech and Medical Devices
The U.S. Food and Drug Administration (FDA) wants to learn more about the safety and effectiveness of medical devices made with or from nanotechnology, and has scheduled a public workshop to find out. The session is set for Wednesday, 23 September 2010 in Gaithersburg, Maryland. According to the notice of the meeting … FDA would…
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FDA Clears Catheter Guidance System
SonoSite Inc. of Bothell, Washington, a maker of ultrasound medical devices, says it received U.S. Food and Drug Administration clearance for its LumenVu Catheter Guidance System, designed to direct the placement of peripherally inserted central catheters (PICC). The company says LumenVu combines near-infrared technology with a fiber optic stylet, which replaces a traditional guide wire,…
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FDA Approves New Blood Pressure Drug
The U.S. Food and Drug Administration (FDA) approved the drug Tekamlo to treat high blood pressure, made by pharmaceutical manufacturer Novartis of East Hanover, New Jersey. Tekamlo tablets combine the renin inhibitor aliskiren with the calcium channel blocker amlodipine. FDA approved Tekamlo as an initial therapy for patients who are likely to need multiple drugs…
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Stem Cell Company: Court Order Not Applicable to Our Work
The chairman of International Stem Cell Corp. (ISCO) in Oceanside, California, says he does not expect the order on Monday of a judge blocking federal funding of embryonic stem cell research to have negative effects on the company’s therapeutic programs. Judge Royce Lamberth of the U.S. District Court for the District of Columbia issued a…
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HHS Review Highlights Role of Business in Medical Countermeasures
The Department of Health and Human Services (HHS) today released a report on the federal government’s system to produce medications, vaccines, equipment, and supplies needed to meet a health emergency. The report — Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs — reviews the process and makes…