Category: Regulations
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Preventive Drugs Found to Stop New HIV Infections
2 September 2015. A large-scale study of preexposure prophylaxis or PrEP, the use of antiviral drugs to prevent HIV infection, found the practice prevented new HIV infections among Kaiser Permanente clients in San Francisco over a 32-month period. Results of the study led by Kaiser Permanente epidemiologist Jonathan Volk, appear in yesterday’s issue of the…
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In-Heart Pacemaker Benefits Shown in Clinical Trial
31 August 2015. First reports from a clinical trial of a heart pacemaker placed inside the heart without wires shows after six months the device maintained effective pacing of patients’ hearts and worked without serious adverse effects in a vast majority of cases. Results of the trial testing the Nanostim device by St. Jude Medical…
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FDA Proposes Guidance, Rule on Biosimilar Naming
28 August 2015. The U.S. Food and Drug Administration proposed new guidance yesterday to provide a common, nonproprietary naming system for generic forms of biologic treatments, known as biosimilars. The agency also proposed a rule applying the system to six biologics and biosimilars already approved, announced with the guidance in a blog post on the…
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Trial Shows Response to Antibody Treating Multiple Myeloma
27 August 2015. An early-stage clinical trial shows some patients receiving an engineered antibody to attack multiple myeloma cancer cells experienced at least a partial remission of their disease. Results of the study, led by oncologist Paul Richardson of Dana-Farber Cancer Institute and Harvard Medical School, appeared yesterday in New England Journal of Medicine. Multiple…
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Alerts in Health Records Cut Delays in Cancer Diagnosis
25 August 2015. Medical researchers found electronic triggers that alert physicians when test results suggest a potential for cancer, reduce delays for patients needing follow-up care. The team led by Hardeep Singh, a professor at Baylor College of Medicine in Houston, published its findings yesterday in Journal of Clinical Oncology (paid subscription required). In addition…
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Early Trial Results Targeting Cancer Mutations Promising
20 August 2015. A clinical trial testing the efficacy of a cancer drug to treat multiple types of cancer based on a common genomic mutation, showed a melanoma drug could treat at least a few other cancers. A team from the U.S. and Europe, led by researchers from Memorial Sloan Kettering Cancer Center in New…
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Glucose Control Implant Bests Diabetes Drug in Trial
19 August 2015. A clinical trial shows an implanted system did a better job of lowering blood glucose levels in people with type 2 diabetes, than an approved glucose control drug. Intarcia Therapeutics in Boston, developer of the system code-named ITCA 650, released top-line results of the late-stage trial testing the device against the drug…
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Cancer Precision Medicine Trial Underway
18 August 2015. A new clinical trial is enrolling participants that tests multiple types of therapies on a number of different cancers based on the genomic make-up of individual patients. The intermediate-stage trial is part of the National Cancer Institute’s Molecular Analysis for Therapy Choice, or NCI-MATCH program. NCI-MATCH seeks to determine if tumors with…
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Trial Shows Fertility Treatment Boosts IVF Pregnancy Rate
11 August 2015. A clinical study of cellular treatments for women using in-vitro fertilization shows the treatments increased pregnancy rates compared to women receiving standard IVF alone. Findings from the study that tested treatments developed by IVF technology company OvaScience Inc. in Cambridge, Massachusetts are scheduled to be published on 25 August in the Journal…
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Trial Shows Weekly Growth Hormone Drug Effective, Safe
30 July 2015. Results of an intermediate-stage clinical trial show a drug candidate to treat growth hormone deficiency in children given once a week, works about as well as a current therapy requiring a daily injection. The results were released by Ascendis Pharma A/S, a specialty pharmaceutical company in Copenhagen, Denmark that conducted the trial.…