Tag: FDA
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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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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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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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FDA Approves Nasal Spray for Opioid Overdose
20 November 2015. The U.S. Food and Drug Administration this week approved the first formulation of a current drug to treat opioid overdose in nasal spray form. The Narcan nasal spray is made by Adapt Pharma Ltd., a company headquartered in Dublin, Ireland. Opioids work by reducing the intensity of pain signals to the brain, particularly…
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Alliance Plans Adaptive Clinical Trials for Brain Cancer
12 November 2015. A global collaboration plans a series of clinical trials that address precise molecular targets testing treatments for glioblastoma multiforme, an aggressive brain cancer. The alliance combines medical teams, researchers, and patient advocates to employ adaptive clinical trials, a type of clinical study that enables investigators to adjust research tactics as results with…
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Artificial Kidney Implant Gains $6 Million Funding
3 November 2015. A collaboration of engineering and medical researchers is developing an implantable artificial kidney to reduce the need for dialysis in people with kidney failure awaiting a transplant. The four-year project combining teams from University of California in San Francisco with Vanderbilt University in Nashville, is funded by a $6 million grant from…
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Regeneron to Develop Antibody Therapy for Ebola
21 September 2015. Regeneron Pharmaceuticals Inc. received a contract from the U.S. Department of Health and Human Services to develop an engineered antibody designed to treat Ebola infections. The initial $17 million contract from HHS’s Biomedical Advanced Research and Development Authority or BARDA covers initial development and testing work on the therapy, but the program…