Category: Regulations
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Pharma Companies Developing 460 Orphan Drugs
A report from the Pharmaceutical Research and Manufacturers of America (PhRMA) says there are now 460 medicines for rare or “orphan” diseases in late stages of the pipeline, either in clinical trials or awaiting Food and Drug Administration (FDA) review. The group says this is the largest number of drugs for orphan diseases in development…
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Ultrasound Advances to Bedside for Routine Diagnoses
Clinicians at the Yale University School of Medicine in New Haven, Connecticut report on advances in ultrasound technology that make it a tool used increasingly for specialties outside of radiology. Yale medical school faculty members Christopher Moore and Joshua Copel describe these advances in this week’s issue of the New England Journal of Medicine (paid…
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Canadians, Americans Get Different Drug Info in Web Searches
A research team at University of British Columbia (UBC) in Vancouver, Canada report that Canadians and Americans get much different search results when they look up prescription drug information online. Their findings were published yesterday in the online issue of the Annals of Pharmacotherapy (paid subscription required). The researchers found residents of the United States…
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FDA Approves Hepatitis C Virus Test
OraSure Technologies Inc. in Bethlehem, Pennsylvania says that the U.S. Food and Drug Administration (FDA) has approved its OraQuick HCV Rapid Antibody Test to detect hepatitis C virus (HCV) antibodies with a fingerstick whole blood sample. The test, says the company, provides results in 20 minutes. OraSure says the OraQuick HCV test is the only…
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Cutting Waste and Costs in the O.R.
A team of researchers from the Johns Hopkins University schools of medicine and public health in Baltimore, Maryland has proposed ways of reducing the environmental footprint of surgeries without compromising patient care. Their recommendations, which also offer potential significant cost savings to hospitals, appear in the February issue of the journal Archives of Surgery (paid…
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U.K. Universities to Forecast Reactor Lifetimes
Materials scientists and engineers from six universities in the U.K. are taking part in a joint project to forecast the life expectancy of the country’s nuclear power reactors. The research team comes from the University of Leeds, with colleagues from the universities of Manchester, Nottingham, Salford, Sussex, and Huddersfield. The project runs for three years,…
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Clinical Trial Record Security Deemed Inadequate
A study of Canadian clinical trial practices shows serious vulnerabilities in the security of participants’ personal data when the data are shared among authorized stakeholders. The findings appear online in the 11 February issue of the Journal of Medical Internet Research. The study, by Khaled El-Emam of Children’s Hospital of Eastern Ontario Research Institute in…
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Two Pesticides Linked to Higher Rates of Parkinson’s Disease
A new study by government and private research institutes shows higher rates of Parkinson’s disease among people using the highly restricted pesticides rotenone and paraquat. The findings were published recently in an online issue of the journal Environmental Health Perspectives. The research team found that people who used either pesticide developed Parkinson’s disease about 2.5…
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European Nanomaterial Reference Repository Created
The European Commission’s research center, based in Italy, has launched Europe’s first nanomaterial repository with a collection representing 25 different types of nanomaterials. The repository, operated by the EC’s Joint Research Centre is expected to aid in safety assessments of nanomaterials. Materials developed at nanoscale (1 nanometer = 1 billionth of a meter) offer a…
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FDA Grants Orphan Drug Status for ALS Candidate
BrainStorm Cell Therapeutics Inc. in Petach Tikvah, Israel says the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s NurOwn adult stem cell product candidate for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. ALS is a progressive neurodegenerative disease of nerve cells in the…