Category: Regulations
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FDA Approves Pediatric HIV Drug Formulation
5 June 2015. The U.S. Food and Drug Administration approved an application for a current HIV drug formulated to better treat infections in infants and young children, especially in limited resource regions. The formulation is a combination of lopinavir and ritonavir in pellet form designed to mix with food, and manufactured by the generic drug…
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Trial Shows Immunotherapy Reduces Rheumatoid Arthritis
4 June 2015. A clinical trial of an immune system therapy shows one treatment reduces levels of harmful immune activity and joint inflammation in people with rheumatoid arthritis. The early-stage trial led by researchers at University of Queensland in Brisbane, Australia is reported yesterday in the journal Science Translational Medicine. Rheumatoid arthritis is an autoimmune disease, where…
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Trial to Test Cancer Drugs Matched to Gene Mutations
2 June 2015. A new clinical trial will test 20 cancer drugs and drug combinations targeted to specific genetic mutations, regardless of cancer type. The study, known as NCI-Match is a joint project of National Cancer Institute, an agency of National Institutes of Health, and the Ecog-Acrin Cancer Research Group, and announced yesterday at the…
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Antibody Improves Lung Cancer Survival Time in Trial
1 June 2015. A late-stage clinical trial shows an engineered antibody that harnesses the immune system increases the survival time of people with a common form of lung cancer compared to standard chemotherapy. The study of the drug nivolumab, marketed as Opdivo by Bristol-Myers Squibb, was reported yesterday at the annual meeting of American Society…
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Genome Interpretation Database, Quality Effort Underway
28 May 2015. A program to improve diagnostics and research based on genomic variations is underway that collects genetic data and implements standards for their interpretation. A description of the Clinical Genome Resource or ClinGen program appears in yesterday’s issue of the New England Journal of Medicine. ClinGen is a collaborative effort of public, academic,…
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Orphan Status Granted Eye Cancer Treatment
21 May 2015. Food and Drug Administration designated an experimental treatment for uveal melanoma, a rare and aggressive form of cancer in the eye, as an orphan drug that qualifies for incentives to expedite its development. Aura Biosciences also revealed results of preclinical tests showing the ability of its lead biologic therapy code-named AU-011 to…
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FDA Approves Four-Times-Per-Year Schizophrenia Drug
19 May 2015. Food and Drug Administration approved for sale in the U.S. a drug for controlling schizophrenia symptoms that individuals need to take only four times per year. Janssen Pharmaceuticals, a division of Johnson & Johnson, markets the three-month version of the drug paliperidone palmitate under the brand name Invega Trinza. Schizophrenia is a…
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National Academies to Develop Gene-Editing Guidelines
18 May 2015. National Academy of Sciences and Institute of Medicine plan to write guidelines governing an emerging technology for editing human genomes. The initiative includes an international meeting in the fall to discuss the scientific, ethical, and policy issues associated with the technology known as CRISPR-Cas9. CRISPR, short for clustered, regularly interspaced short palindromic…
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Trial Shows Antibody Reduces Days with Migraines
15 May 2015. A clinical trial shows high doses of an engineered antibody reduced the number of days per month that people with a history of migraines experience migraine episodes. First findings from the intermediate-stage trial of the antibody code-named AMG334 by the biotechnology company Amgen were reported at a meeting of the International Headache…
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Trial Testing 3-Drug Combo for Drug Resistant TB
14 May 2015. A new clinical trial is underway in South Africa testing a regimen of three drugs to treat extensively drug-resistant tuberculosis, a form of the disease that does not respond to normal or even back-up treatments. The trial is sponsored by Global Alliance for TB Drug Development, or TB Alliance, an international consortium…