Category: Regulations
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Trial Testing Stem Cell Therapy for Spinal Cord Injury
5 March 2015. A clinical trial testing a stem cell therapy for spinal cord injury is recruiting patients at an Atlanta rehabilitation center. The intermediate-stage trial, conducted by biotechnology company Asterias Biotherapeutics, aims to initially enroll 13 adults to test three dosage levels of neural stem cells designed to restore motor functions to spinal cord…
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Trial to Test Video Game Therapy for Autism
2 March 2015. A clinical trial plans to begin recruiting participants to test a video game designed to engage areas of the brain for building cognitive skills affected by autism. The trial, conducted by Akili Interactive Labs that developed the game, is funded by Delivering Scientific Innovation for Autism or Delsia LLC, a subsidiary of the…
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Adult Stem Cell Quality Control Methods Devised
27 February 2015. A European research team developed a process for testing the safety and quality of adult stem cells before being used in gene therapy treatments on patients. The team led by stem cell scientist Yann Barrandon at the Swiss Federal Institute of Technology in Lausanne published its findings today in the journal EMBO…
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Registry to Track Psoriasis Drug Safety
26 February 2015. A new registry of patients with psoriasis will track the safety of a recently approved biologic drug designed to treat that disorder. The Corrona Psoriasis Registry is a joint undertaking of National Psoriasis Foundation and Corrona LLC, a company in Southborough, Massachusetts hosting registries of patients with chronic diseases. Psoriasis is an…
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New Medical Device Surveillance System Proposed
23 February 2015. A report today by a Washington, D.C. think tank proposes a new system for tracking medical devices after going on the market, to better serve patients and encourage innovation in the field. A conference at Brookings Institution that published the report highlighted many of the benefits, but also difficulties the proposed system…
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FDA Allows 23andMe to Resume Genetic Health Tests
20 February 2015. The U.S. Food and Drug Administration authorized the personal genetics company 23andMe to begin marketing genetic tests for carrying the gene causing Bloom syndrome, a serious inherited disorder. FDA also yesterday began classifying gene-carrier screening tests as class-2 medical devices requiring a limited degree of regulation, and exempting the tests from pre-market…
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RNA Flu Therapy Clinical Trials Complete Enrollment
19 February 2015. Two late-stage clinical trials testing an influenza treatment that disrupts a virus’s genetic replication ability finished recruiting more than 2,000 participants worldwide. The trials are being conducted by MediVector Inc., a drug development company in Boston, for Joint Project Manager Medical Countermeasure Systems, an office in the U.S. Department of Defense developing…
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Thyroid Cancer Drug Approved by FDA
16 February 2015. The U.S. Food and Drug Administration approved on Friday a drug for differentiated thyroid cancers, where the cancer continues to grow despite treatments with radioactive iodine. The drug, lenvatinib, is marketed by Eisai Inc. in Woodcliffe, New Jersey, under the brand name Lenvima. The thyroid gland helps the body regulate metabolism, using…
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Devices Assembled to Record Doctor-Patient Interactions
13 February 2015. Computer scientists at University of California in San Diego assembled a collection of audio and video devices into a portable package that records doctors’ consultations with patients when also using electronic health records. The team led by computer science researcher Nadir Weibel that includes members from San Diego university and veterans’ medical…
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FDA Sanctions Not Mentioned in Published Clinical Trials
10 February 2015. An investigation by a New York University journalism professor shows serious violations in clinical trials revealed in Food and Drug Administration inspections are largely not mentioned in reports of those trials in scientific journals. The findings of Charles Seife and his team from NYU’s journalism school were published yesterday in the journal…