Category: Regulations
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Multiple Myeloma Gene Therapy Trial Underway
19 February 2016. The biotechnology company bluebird bio began testing its experimental gene therapy for multiple myeloma in an early-stage clinical trial. The Cambridge, Massachusetts company — which spells its name in all lower-case letters — is also licensing the technology tested in the trial to the pharmaceutical company Celgene. Multiple myeloma is a cancer of…
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Patch Finds Heart Problems After Holter Monitor Period
17 February 2016. A review of records of people wearing a single-use heart monitor patch found serious heart rhythm problems occurring well after the 48-hour period recommended for Holter monitors, the device used most often for ambulatory heart monitoring. Results of the study, conducted by researchers at Kaiser Permanente of Northern California, but sponsored by…
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Test IDs Mesothelioma Years Before Symptoms Appear
5 February 2016. A company spun-off from Purdue University designed a test that in a recent study detects cases of mesothelioma, a form of lung cancer, several years before symptoms develop. Results of the study conducted by MorNuCo Laboratories in West Lafayette, Indiana appear in the 22 January issue of the journal Clinical Proteomics. Mesothelioma is…
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FDA Assessing Opioid Regulatory Reviews, Labeling
4 February 2016. U.S. Food and Drug Administration is evaluating its practices on reviewing applications for new opioid pain drugs and their labeling requirements, in light of the expanding epidemic of abuse and overdose. An action plan with these steps was released today, although funding for new initiatives was not discussed. Opioids work by reducing the…
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Many FDA Advisory Speakers Found with Industry Funding
2 February 2016. A review of an FDA advisory committee on cancer drugs finds nearly one-third of speakers at its meetings receive financial support from companies making the drugs under review. The analysis by Vinay Prasad at Oregon Health and Science University and Matthew Abola, a medical student at Case Western Reserve University, is reported…
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FDA Approves Nasal Spray Migraine Therapy
29 January 2016. The Food and Drug Administration approved a treatment for migraine headaches delivered as a powder sprayed into the nose. The therapy, marketed as Onzetra by Avanir Pharmaceuticals, is a formulation of sumatriptan, an approved oral drug for treating migraine symptoms. Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and…
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Safety, Activity Assessed in New Duchenne Drug
25 January 2016. An early-stage clinical shows an experimental drug for Duchenne muscular dystrophy is safe for patients and produces the desired chemical activity in the body. Results of the trial, conducted by Catabasis Pharmaceuticals were released today. The Cambridge, Massachusetts company says it is now extending the study to test the drug against a…
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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…