Category: Regulations
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Trial Underway Testing Preterm Respiratory Treatment
30 December 2015. A clinical trial testing new treatment methods for a common respiratory disorder faced by preterm babies began enrolling patients. The trial is testing an aerosol-delivered surfactant, a wetting agent applied to the lungs of babies born prematurely without natural surfactants to keep open air sacs in lungs, made by Discovery Laboratories a biotechnology…
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Trial Underway Testing Opioid Dependency Treatments
15 December 2015. A late-stage clinical trial testing weekly and monthly treatments of injected buprenorphine for opioid drug dependence began enrolling patients. The trial is testing the drug code-named CAM2038 developed by the pharmaceutical company Camurus AB in Lund, Sweden, and licensed to Braeburn Pharmaceuticals in Princeton, New Jersey that offers treatments for neurological conditions.…
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High Blood Cancer Response Rates Found for Cell Therapies
8 December 2015. Two clinical trials of personalized immune cells to treat blood-related cancers — acute lymphoblastic leukemia in children and non-Hodgkin lymphoma in adults — showed high rates of response and remission. Results of the two trials, conducted by University of Pennsylvania medical school, were reported earlier this week at a meeting of American…
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Trial Underway Testing Flesh-Eating Bacteria Drug
7 December 2015. A late-stage clinical trial began enrolling patients to test a new treatment for rare, but dangerous bacterial infections that destroy soft tissue and muscle. The trial is testing AB103, a biologic therapy developed by the biotechnology company Atox Bio in Ness Ziona, Israel. AB103 is designed to treat necrotizing soft tissue infections,…
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GMO Database Begun for European Regulators
30 November 2015. A database of DNA sequences found in genetically modified organisms or GMOs opened on Friday to help European regulators detect GMOs in food and feed products. The GMO-Amplicons database, available to the public, is run by the Joint Research Centre, the in-house science policy service of the European Commission. Europe now grows…
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FDA Approves Antibody Treatment for Lung Cancer
25 November 2015. U.S. Food and Drug Administration yesterday approved necitumumab, an engineered antibody to treat squamous non-small cell lung cancer that spreads to other parts of the body. Necitumumab is marketed under the brand name Portrazza by Eli Lilly and Company. Worldwide, lung cancer causes some 1.6 million deaths, according to World Health Organization. Non-small cell lung…
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Antibodies to Treat Staph Infections in Early Trial
24 November 2015. A study testing the safety of antibodies to prevent and treat Staphylococcus aureus infections, including those contracted in hospitals, is underway in Vienna, Austria. The clinical trial is evaluating an experimental biologic drug for the prevention and treatment of S. aureus or staph infections made by Arsanis Biosciences, a biotechnology company in…
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Trial Tests Vibrating Mattress to Prevent Infant Apnea
24 November 2015. A mattress that provides occasional mild vibrations was shown in a clinical trial to prevent episodes of interrupted breathing in preterm babies, a condition known as infant apnea. Results of the study testing the device, developed at the Wyss Institute, a biomedical engineering research center at Harvard University, were reported yesterday in…
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FDA Approves Nasal Spray for Opioid Overdose
20 November 2015. The U.S. Food and Drug Administration this week approved the first formulation of a current drug to treat opioid overdose in nasal spray form. The Narcan nasal spray is made by Adapt Pharma Ltd., a company headquartered in Dublin, Ireland. Opioids work by reducing the intensity of pain signals to the brain, particularly…
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Trial Testing MRI Depression Treatment with Teens
2 November 2015. A new clinical trial is recruiting adolescents with major depressive disorder to test a therapy using magnetic resonance imaging impulses. The study is testing the NeuroStar TMS Therapy System, already approved for adult patients with major depressive disorder who do not respond to medications. Depression is a widespread condition, which when it becomes…