Category: Regulations
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Trial Underway Testing Pancreatic Cancer Immunotherapy
10 February 2014. Aduro BioTech Inc. in Berkeley, California started treating ist first patients in an intermediate-stage clinical trial of immunotherapies for pancreatic cancer. The trial is expected to enroll 240 patients at 20 sites in the U.S. and Canada, and is still recruiting participants. Pancreatic cancer is often difficult to diagnose in its early…
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Shire to End Major Depression Drug Booster Development
7 February 2014. Shire PLC, a pharmaceutical company in the U.K., will end trials of its drug Vyvanse as a supplement to anti-depressants for treating major depressive disorder. The company made the decision following results of two late-stage clinical trials that show the drug failed to meet the studies’ effectiveness objectives. Vyvanse (lisdexamfetamine dimesylate) is…
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Telemedicine Found to Expand Care to Less Engaged Patients
4 February 2014. A study by Rand Corporation, a policy analysis organization, indicates people who use a service that makes possible medical help from a doctor over the telephone tend to be those without established health care relationships. The findings of Rand policy analysts Lori Uscher-Pines and Ateev Mehrotra appear in the February 2014 issue…
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Football Helmet Design Shown to Reduce Concussion Risk
31 January 2014. Biomedical engineers at Virginia Tech in Blacksburg found a helmet design that better absorbs head impact can reduce the rate of concussions among college football players. The team led by Virginia Tech research professor Steve Rowson, with colleagues from seven other institutions, published its findings online today in Journal of Neurosurgery. Recent…
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Early Trial Finds Vaccine Booster Covers Pandemic Flu Types
30 January 2014. An early-stage clinical trial shows an RNA agent being developed by Hemispherx Biopharma in Philadelphia extends the effectiveness of the standard nasal flu vaccine to cover pandemic influenza strains, like those found in Pacific Rim countries. Results of the trial were presented yesterday at a meeting of the American Society for Microbiology…
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Mayo Clinic Taking Part in ALS Stem Cell Clinical Trial
29 July 2014. BrainStorm Cell Therapeutics, a biotechnology company in New York and Israel says the Mayo Clinic in Rochester, Minnesota is now taking part in a clinical trial of the company’s treatments for amyotrophic lateral sclerosis (ALS) that harness the patient’s own bone marrow stem cells. Financial aspects of the agreement were not disclosed.…
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FDA Approves Spine Compression Fracture Implant Device
28 January 2014. An implant device to treat vertebral compression fractures, made by Benvenue Medical Inc. in Santa Clara, California, was approved for sale in the U.S. by the Food and Drug Administration. The company’s Kiva VCF System treats vertebral compression fractures that occur most often to people with osteoporosis, but can also happen in cases…
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Report: PCORI Needs More Focus on Effectiveness Research
24 January 2014. A report released today by Center for American Progress, a progressive think tank in Washington, D.C., calls for the organization formed to study comparative effectiveness of treatment options to focus more on the research for which it was created. The Patient-Centered Outcomes Research Institute (PCORI) was established in a provision of the…
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FDA Fast-Track Granted to Cancer Therapy Side-Effects Drug
BioAlliance Pharma SA in Paris says its drug candidate to treat inflammation of the mucus membranes in the mouth, resulting from chemo- or radiation therapy to treat cancer, received fast-track status from the U.S. Food and Drug Administration. Validive, the drug’s brand name, is designed for patients with head and neck cancers. Oral mucositis is…
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Trial Underway Testing Head-Neck Cancer Immunotherapy
Advaxis Inc., a biopharmaceutical company in Princeton, New Jersey, began dosing the first patient in clinical trial testing a therapy that harnesses the immune system to treat head and neck cancer caused by the human papillomavirus, or HPV. The therapy is designed as part of a therapy strategy that includes robotic surgery to remove the…