Category: Regulations
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Vaccine Shown to Give 1-Year Malaria Protection
10 May 2016. An early-stage clinical trial with healthy volunteers shows an experimental vaccine can protect against malaria infection for as long as 1 year. Results of the trial, conducted by National Institute of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health, and University of Maryland Medical Center in Baltimore, appear…
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566 New Drugs in Pipeline for Orphan Diseases
9 May 2016. A report by an industry group says 566 drugs designed to treat rare diseases are now in clinical testing by pharmaceutical companies. The report, prepared by Pharmaceutical Research and Manufacturers of America, or PhRMA, and the ALS Association, credits many of these new drugs to incentives in legislation encouraging research and development…
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Trial Underway Testing Antibody for Celiac Disease
5 May 2016. A clinical trial testing an engineered antibody therapy for celiac disease in people that do not respond to a gluten-free diet began treating its first patients. The trial is conducted by Celimmune LLC, a biopharmaceutical company in in Lebanon, New Jersey, but patients are recruited in Finland, where the rate of celiac…
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Drug Pricing Reform Even Big Pharma Might Like
2 May 2016. At a press event in Washington, D.C. last week, Representative Lloyd Doggett of Texas, a champion of lower prescription drug prices, took aim at drug companies and their business practices. “An unaffordable drug is 100 percent ineffective,” Doggett told an audience at Center for American Progress on 26 April. He noted that…
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Engineered T-Cells Get High Leukemia Remission in Trial
28 April 2016. A clinical trial shows engineered immune-system cells transplanted in patients with one form of leukemia achieves a 93 percent remission rate. Results of the trial, at the Fred Hutchinson Cancer Research Center in Seattle, were reported in the 25 April issue of The Journal of Clinical Investigation. Fred Hutchinson Center researchers were…
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NIH Closes Two Clinical Facilities for Sterility Issues
20 April 2016. National Institutes of Health closed two of its clinical facilities found not in compliance with safety and quality standards that could put patients at risk. Facilities at NIH closed for not meeting Current Good Manufacturing Practice standards are a cell therapy production lab at National Cancer Institute and a production center for…
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Many Clinical Trial Protocol Changes Avoidable, Costly
12 April 2016. When clinical trials make changes in plans, known as protocol amendments, after they’re underway, the impact in time and costs are substantial, with many changes considered avoidable. These are conclusions of a review of clinical trial protocol amendments carried out by Center for the Study of Drug Development at Tufts University in…
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Trial Shows Pain Drug Effective as Heroin Treatment
7 April 2016. A clinical trial in Canada shows a drug already in use for chronic pain can serve as a substitute maintenance treatment for people addicted to heroin. The findings of the trial, conducted by University of British Columbia in Vancouver and other institutions in Canada, appear 6 April in the journal JAMA Psychiatry.…
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Stem Cells Shown to Improve Heart Failure Health Outcomes
5 April 2016. Results from a clinical trial show a new therapy for heart failure using patients’ own blood-forming stem cells reduces worsening symptoms, hospitalizations, and deaths. Findings of the study testing the treatments developed by biopharmaceutical company Vericel Corp., which funded the trial, appear in today’s issue of the journal The Lancet (paid subscription…
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Gene-Editing Therapy Advances for Rare Immune Disorder
1 April 2016. A key committee of the European Medicines Agency recommends approval of treatments for a rare children’s immune disease that uses edited genes as therapy. The Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency at its March 2016 meeting recommended approving Strimvelis by GlaxoSmithKline to treat adenosine-deaminase-deficient…