Category: Regulations
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Duchenne-Related Stem Cell Heart Therapy Trial Underway
22 February 2016. An early clinical trial testing a stem cell therapy for heart disease among individuals with Duchenne muscular dystrophy treated its first enrolled patient. The trial is conducted by Capricor Inc. in Los Angeles, developer of the treatments code-named CAP-1002, for cardiomyopathy or heart failure related to Duchenne muscular dystrophy. Duchenne muscular dystrophy is…
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Pain Medication Given FDA Breakthrough Tag
22 February 2016. A new drug to treat moderate to severe pain, now in clinical trials, received a breakthrough designation from the U.S. Food and Drug Administration. The drug, oliceridine, is made by Trevena Inc. in King of Prussia, Pennsylvania. Oliceridine addresses the same pain signals as opioid drugs that affect areas of the brain…
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FDA Approves New Epilepsy Drug
19 February 2016. The U.S. Food and Drug Administration approved a molecular therapy for epilepsy designed to supplement treatments for partial-onset seizures. The drug is brivaracetam, marketed as Briviact by UCB, a pharmaceutical company headquartered in Brussels, Belgium. Epilepsy is a neurological disorder where nerve cell activity in the brain is disturbed, causing seizures with symptoms…
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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…