Category: Regulations
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Trials Show Safety, Benefit of Stem Cells to Treat ALS
11 January 2016. Two clinical trials testing stem cells to treat amyotrophic lateral sclerosis, or ALS, found the treatments are safe for patients, and can slow progression of the disease. Results of the trials testing the stem cell product known as NurOwn made by BrainStorm Cell Therapeutics in Petach Tikvah, Israel are reported today in…
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Electronic Stimulation Shown to Reduce Arthritic Knee Pain
5 January 2015. Results from a clinical trial show a device emitting electronic pulses reduced more pain in the knees of people with osteoarthritis, compared to a placebo. Findings from the study, conducted by a team from University of Messina in Italy, appear in the January 2016 issue of the journal Rheumatology. The trial tested…
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Medical Industry Payment Recipients Identified
5 January 2016. An analysis of industry payments to physicians shows cardiovascular specialists and neurosurgeons were the specialties most likely to receive payments from pharmaceutical and medical device companies. The findings appear in this month’s issue of the journal Mayo Clinic Proceedings. The research team from University of California in San Diego, led by radiation…
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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…