Category: Regulations
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FDA Grants Orphan Status to Brain Cancer Surgery Aid
7 July 2015. The U.S. Food and Drug Administration is granting orphan drug status to an engineered peptide that illuminates brain cancer cells making them easier to surgically remove. The treatment, code-named BLZ-100, is made by Blaze Bioscience, a biotechnology company in Seattle. Blaze Bioscience is a spin-off enterprise from Fred Hutchinson Cancer Research Center,…
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Poll: Parents Consider Vaccines Safe, Beneficial
6 July 2015. A nationwide survey of parents in the U.S. shows the vast majority of parents believe vaccines for children are as safe and beneficial as a year ago, with sizable numbers — from a quarter to a third — saying vaccines’ safety and benefits are increasing. The results were published today by C.S.…
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Drug Abusers, Smokers More Likely to Use Opioids Long-Term
1 July 2015. A study by the Mayo Clinic finds people with a history of substance abuse and using tobacco are those most at risk for using opioid pain killers on a continuous basis. The team led by Michael Hooten, an anesthesiologist at Mayo Clinic in Rochester, Minnesota, published its findings in the July issue…
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Point-of-Care Ebola Test Found Accurate in Field Test
26 June 2015. A commercial point-of-care test detecting Ebola virus in the blood of a patient was shown in a field test in Sierra Leone to be as accurate as tests sent to remote labs for analysis. Results of the study led by Nira Pollock of Harvard Medical School and Boston Children’s Hospital were published…
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Trial Shows Safety, Benefits of Diabetic Eye Disease Drug
25 June 2015. An early-stage clinical trial of a drug to treat eye disorders caused by diabetes shows the drug is well-tolerated and reduces swelling in the eye associated with the disease. Stealth BioTherapeutics, developer of the drug brand-named Ocuvia, reported the results today at a company symposium in New York City. The study is…
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Trial Begins Testing Sickle Cell Blood Therapy
23 June 2015. A clinical trial began enrolling participants testing a synthesized therapy for sickle cell disease to improve the flow of blood cells blocked by the condition and relieve the intense pain that results. The late-stage trial is being conducted by drug maker Pfizer Inc., with biotechnology company GlycoMimetics Inc. in Gaithersburg, Maryland. Sickle…
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Study Urges Better Heart Implant Device Tracking
22 June 2015. Current methods of monitoring implanted heart devices, conclude researchers at University of California in San Francisco, may not be adequate for spotting the number of problems with the devices leading to patients’ deaths. The findings of the team led by UCSF cardiologist Zian Tseng were reported today in the journal JAMA Internal Medicine…
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Trial Testing Precision Medicine as Skin Cancer Therapy
18 June 2015. A clinical trial is recruiting participants to test targeted molecular therapies as treatments for advanced cases of skin cancer. The study plans to enroll 96 individuals with melanoma, an advanced and dangerous form of skin cancer, found spreading to other organs in the body and cannot be treated with surgery. Melanoma results…
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Trial Underway Testing Immunotherapy for Gout
10 June 2015. An early-stage clinical trial is recruiting patients to test the safety of a treatment for severe gout that harnesses the immune system, but still avoids unwanted immune responses. The trial is conducted by the biotechnology company Selecta Biosciences at two sites in the U.S.: Altoona, Pennsylvania and Dallas, Texas. Gout is a…
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Companies Form Fertility Treatment Technologies Alliance
8 June 2015. An alliance of drug, genomic, and assisted fertility technology companies are collaborating on processes and standards that encourage more consistency in results from assisted reproductive treatment labs. Financial details of the Global Fertility Alliance joining Illumina, Merck, and Genea were not disclosed. The three companies aim to improve outcomes in fertility clinics…