Category: Regulations
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Clinical Trial to Test Advanced Lung Cancer Immunotherapy
7 April 2014. EMD Serono, a subsidiary of the pharmaceutical company Merck in Rockland, Massachusetts, is beginning a clinical trial to test a vaccine-type therapy for advanced cases of non-small cell lung cancer. The late-stage trial is assessing the ability of tecemotide, an experimental drug designed to trigger an immune response against cancer cells, to…
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Trial Shows Gene Test Improves Lung Cancer Diagnostics
2 April 2014. Allegro Diagnostics Corp. in Maynard, Massachusetts says results from a clinical trial testing its genomic technique for diagnosing lung cancer more accurately predicts development of the disease among former smokers than standard bronchoscopies working alone. The company plans to discuss the findings next month at an American Thoracic Society meeting in San…
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Trial to Test Engineered DNA Therapy for Preeclampsia
31 March 2014. The biopharmaceutical company rEVO Biologics in Framingham, Massachusetts is starting a clinical trial of its drug ATryn to treat women in mid-pregnancy with preeclampsia. The company says the U.S. Food and Drug Administration gave its approval for the trial to begin. Preeclampsia is a life-threatening condition resulting from a sudden rise in…
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Biotech Group Issues Clinical Trial Data Sharing Guidelines
25 March 2014. Biotechnology Industry Organization (BIO) today released its principles for sharing data from clinical trials that encourage making more data available from clinical trials, but leave procedures for sharing up to the individual companies. The guidelines cover programs resulting in approved medicines, as well as those discontinued for safety or efficacy reasons, although…
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Early Trial Shows Wireless Pacemaker Safe, Effective
24 March 2014. Researchers at Mount Sinai Hospital in New York found in an early-stage clinical trial, a smaller and lead-less heart pacemaker could be safely implanted and operate for at least three months without complications. The team led by Mount Sinai cardiologist Vivek Reddy — with colleagues in Netherlands, Germany, and Czech Republic, and…
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FDA Approves Celgene Psoriatic Arthritis Treatment
24 March 2014. The U.S. Food and Drug Administration on 21 March approved the drug apremilast to treat adults with active cases of psoriatic arthritis. The drug is marketed as Otezla by the pharmaceutical company Celgene in Summit, New Jersey, that also reported results of clinical trials of Otezla to treat the related skin condition…
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Emergency Room Opioid Prescriptions Jump in 2001-2010
14 March 2014. Medical researchers at George Washington University in Washington, D.C. found large increases in prescriptions for opioid pain-killers in U.S. hospital emergency rooms over the 2001-2010 decade. The team led by emergency medicine faculty Maryann Mazer-Amirshahi published its findings online yesterday in the journal Academic Emergency Medicine (paid subscription required). Mazer-Amirshahi and colleagues analyzed data…
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Trial Underway to Test Mutation Fix for Cystic Fibrosis
12 March 2014. An early-stage clinical trial is underway testing the safety and chemical activity of a drug designed to correct a genetic mutation causing cystic fibrosis. The study, sponsored by N30 Pharmaceuticals Inc. in Boulder, Colorado — the drug’s inventor — aims to enroll up to 40 healthy adults. Cystic fibrosis is an inherited disease…
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Biotech Partnership to Develop Non-Ricin Castor Plants
12 March 2014. Precision BioSciences Inc. and Novo Synthetix, biotechnology companies in Durham, North Carolina, are collaborating on a new type of castor bean, without the ricin poison that makes the beans difficult to process and market. Financial and intellectual property aspects of the deal were not disclosed. Beans from castor plants (Ricinus communis) have the potential to…
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Store Checkout Data Generate Neighborhood Food Profiles
11 March 2014. An epidemiologist at McGill University in Montreal, Quebec, Canada devised a method for tracking food choices, with data from food stores, that helps gauge family nutrition in city neighborhoods. The team led by McGill’s David Buckeridge published its findings online in a recent issue of the Annals of the New York Academy of Sciences…