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US FDA Ahead Of Canada, Europe In Drug-Approval Race
The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe, according to a new study by Yale School of Medicine researchers. The study counters perceptions that the drug approval process in the United States is especially slow. Led by second-year medical student Nicholas Downing and senior author Joseph S. Ross, M...

Expert Group Recommend That World Health Assembly Should Adopt An International Convention On Global Health R&D
The expert working group advising WHO on research and development has recommended the May 2012 World Health Assembly adopt an international convention on research and development (R&D) that will bind member states to action and catalyze new knowledge for diseases that primarily affect the global poor but for which patents provide insufficient market incentives...

The New Pharmacovigilance Legislation Will Impact US And European Drug Manufacturers
The Pharmacovigilance Legislation Will Come into Effect in July As the European Medicines Agency's new PV (pharmacovigilance) Legislation implementation date of July 2012 approaches, US and European pharmaceutical and biotech companies need to ask themselves if they are ready for the changes that lie ahead, says Paul Beninger, MD, FACP, Vice President, Global Patient Safety, Genzyme...

PETA Grant Enables Scientists To Guide Chinese Officials In Non-Animal Test Use
Chinese officials are in the final stages of approving the use of the country's very first non-animal test method for cosmetics ingredients, thanks to guidance from scientists funded by PETA. The 3T3 Neutral Red Uptake Phototoxicity Assay, which tests chemicals for their potential toxicity when they come into contact with sunlight and is already in widespread use in the U.S. and the E.U...

Identifying Drugs That Could Help Fight Broad Range Of Viruses
Results of a new study demonstrate the feasibility of a novel strategy in drug discovery: screening large numbers of existing drugs - often already approved for other uses - to see which ones activate genes that boost natural immunity. Using an automated, high-volume screening technique, researchers at Washington University School of Medicine in St...

Drug Safety Monitoring Should Be Expanded After Approval
Pharmaceutical drugs approved by the Food and Drug Administration (FDA) but later re-called from the market - such as the antidiabetic drug Avandia and pain-reliever Vioxx - were the impetus for an Institute of Medicine committee report, recommending that the FDA take proactive steps to continue monitoring drugs' safety after initial approval and throughout their time on the market...

Recent History Of A Mystery In Canadian Drug Shortages
The shortage of prescription generic drugs in Canada is not a recent event, dating back to the fall of 2010 or earlier, states a recent history of the shortage in CMAJ (Canadian Medical Association Journal). Hematologist and medical historian Dr. Jacalyn Duffin first noticed the shortage of an old, reliable drug in November 2010...

Full Reports From Trials Should Be Public: Regulators Respond To Tamiflu Recommendations
The full clinical study reports that drugs that have been authorized for use in patients should be made publicly available in order to allow independent re-analysis of the benefits and risks of such drugs, according to leading international experts who base their assertions on their experience with Tamiflu (oseltamivir)...

Bacterial Contamination Found In Pharmacy Robots
Drug dispensing robots designed to quickly prepare intravenous medications in a sterile environment can harbor dangerous bacteria, according to a report in Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America...

Improving Quality Of Life For Lab Mice Leads To Better Science
Nine out of 10 drugs successfully tested in mice and other animal models ultimately fail to work in people, and one reason may be traced back to a common fact of life for laboratory mice: they're cold, according to a researcher at the Stanford University School of Medicine...

E.coli Bacteria Help Produce Faster And Cheaper Medications
A discovery published in the March 25 issue of Nature Chemical Biology reveals that biomolecular engineers from Cornell University have discovered that Escherichia coli, a bacteria that is considered to be a severe threat in terms of food safety by restaurateurs, grocers and consumers, is in fact, a friendly bacteria. The researchers discovered that the E...

More Effective Cancer Drugs May Result From Mapping Of Substrate-Kinase Interactions
Later-stage cancers thrive by finding detours around roadblocks that cancer drugs put in their path, but a Purdue University biochemist is creating maps that will help drugmakers close more routes and develop better drugs. Kinase enzymes deliver phosphates to cell proteins in a process called phosphorylation, switching a cellular function on or off...

Bioorthogonal Chemistry - Making Drugs Inside Patients - And More
The traditional way of making medicines from ingredients mixed together in a factory may be joined by a new approach in which doctors administer the ingredients for a medicine separately to patients, and the ingredients combine to produce the medicine inside patients' bodies...

Nanopills Release Drugs Directly From The Inside Of Cells
UAB researchers developed a new vehicle to release proteins with therapeutic effects. The vehicles are known as "bacteria inclusion bodies", stable insoluble nanoparticles which are found normally in recombinant bacteria...

Discovering New Drugs More Cheaply Using Liposome Microarray Technology
Researchers at the Florida State University have developed a new technology which could substantially reduce the cost of drug discovery. The study, published in the recent issue of Biomaterials, could lead to better and improved access to high-quality health care and personalized chemotherapy treatments for cancer patients...