Category: Regulations
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Youth E-Cigarette Use Seen as Smoking Gateway
9 September 2015. A survey of teens and young adults in the U.S. shows those who smoke electronic cigarettes are much more likely to start smoking tobacco within one year. Results of the study, conducted by a team from University of Pittsburgh and Dartmouth University medical centers, appear online in yesterday’s issue of the journal…
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Spinal Cord Injury Device Trial Completes Enrollment
8 September 2015. An early-stage clinical trial testing an implanted biocompatible plastic framework to encourage healing of spinal cord injuries completed its initial enrollment. The Neuro-Spinal Scaffold device is made by InVivo Therapeutics Holdings Corp. in Cambridge, Massachusetts. Spinal cord injuries are usually caused by a sudden, traumatic blow to the spine that bruises or tears…
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Hemophilia Therapy Candidate Given Breakthrough Status
4 September 2015. A synthetic antibody designed to prevent bleeding episodes among people with the most common type of hemophilia received a breakthrough therapy designation from the U.S. Food and Drug Administration. The pharmaceutical company Roche says FDA assigned the designation its biologic therapy code-named ACE910, now being tested in clinical trials. Hemophilia is an inherited…
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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…