Category: Regulations
-
FDA Approves Rare Congenital Blood Disease Treatment
The U.S. Food and Drug Administration yesterday approved a treatment for congenital factor XIII A-subunit deficiency, a rare blood clotting disorder, made by the pharmaceutical company Novo Nordisk, based in Denmark. Tretten, the medication’s brand name, is an engineered biologic designed to prevent bleeding in adults and children with the disorder. People with factor XIII…
-
Monthly Pharmacist Appointments Improve Medication Adherence
Researchers at Virginia Commonwealth University in Richmond found regular monthly appointments with pharmacists can help patients keep taking their medications as prescribed. Pharmacy professor David Holdford and then-doctoral candidate Timothy Inocencio published their findings in the current issue of the Journal of the American Pharmacists Association (subscription required). A study published earlier this year in…
-
Early Trial Tests Stem Cell Immunotherapy for Liver Cancer
An early stage clinical trial by California Stem Cell Inc. in Irvine tested a therapy harnessing the body’s immune system to treat a common form of liver cancer. The trial, conducted with eight patients in Shanghai, China, showed the treatments were safe for patients with hepatocellular carcinoma and did not cause complications, according to the…
-
Graphic Labels Reduce Smoking More Than First Thought
Public health researchers at University of Illinois in Chicago and University of Waterloo in Ontario, Canada found graphic warnings on cigarette packs can reduce smoking to a greater extent than the U.S. Food and Drug Administration estimated two years ago. The team led by Chicago’s Jidong Huang published its findings online earlier this month in…
-
FDA Approves Sale of High-Throughput DNA Sequencing Systems
The U.S. Food and Drug Administration yesterday cleared for marketing high-throughput sequencing systems by Illumina Inc. in San Diego to analyze a person’s DNA. In a commentary on this approval in New England Journal of Medicine, FDA director Margaret Hamburg and National Institutes of Health director Francis Collins say, “Access to these data opens the…
-
Nutritional Labeling Leads to Healthier Restaurant Choices
A study in Philadelphia shows consumers who read nutritional labels on restaurant menus purchase items lower in calories, sodium, and saturated fats than patrons of that restaurant chain overall. The results of the study by researchers at Drexel University, University of Pennsylvania, and Philadelphia’s public health department appear online in yesterday’s advance issue of the…
-
Trial Shows No Benefit from GSK Chronic Heart Disease Drug
The global pharmaceutical company GlaxoSmithKline (GSK) reported today in a late-stage clinical trial its candidate drug darapladib to treat chronic coronary heart disease did not meet its goal of increasing the amount of time between severe heart problems compared to a placebo. The company says some of the trial’s secondary goals related to coronary events…
-
Simple Test Cuts Antibiotic Use Among Sore Throat Patients
Researchers at University of Southampton and other institutions in the U.K. and Australia found a simple nine-item test can help clinicians better determine if patients complaining of a sore throat need antibiotics. The team led by Southampton’s Paul Little, professor of primary care research, published its findings in a recent issue of the British Medical…
-
Software Design Found to Influence Lab Test Choices
A psychologist at University of Missouri in Columbia found the design of software used by physicians influences their choice of diagnostic tests when admitting new patients to hospitals, with implications for the quality of patient care and health care costs. Victoria Shaffer in Missouri’s Department of Health Sciences, with Adam Probst from Baylor Scott &…
-
FDA Approves Leukemia Treatment, First Breakthrough Therapy
The U.S. Food and Drug Administration on Friday approved an antibody designed to treat chronic lymphocytic leukemia, when taken with chemotherapy. Obinutuzumabm — developed and marketed as the brand name Gazyva by the biotechnology company Genentech, a division of Roche in South San Francisco, California — is the first drug designated as a breakthrough therapy approved…