Regulatory Recon: FDA Accepts Spark’s Gene Therapy Application; Amgen Gets CRL for Osteoporosis Candidate … – Regulatory Focus
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Regulatory Recon: FDA Accepts Spark’s Gene Therapy Application; Amgen Gets CRL for Osteoporosis Candidate …
Regulatory Focus Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals … |
Philly.com |
Philly biotech’s first-ever gene therapy progresses with FDA
Philly.com If approved, the treatment would be the first gene therapy for a genetic disease in the United States. Spark’s treatment, called voretigene neparvovec, streams genes directly into the eye’s retina. It has been granted priority review by the FDA because … FDA embraces the first US application for a gene therapy, offering an accelerated test caseEndpoints News Spark files revolutionary gene therapy with FDApharmaphorum FDA accepts biologics license application for voretigene neparvovecHealio Nasdaq all 24 news articles » |
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CNIC research holds potential to improve current cancer immunotherapy strategies
News-Medical.net Immunotherapy, the use of the immune system to fight cancer, is revolutionizing treatment of this disease, and was selected by the prestigious journal Science as the major scientific advance of 2013. According to study leader David Sancho, “Cancer … |
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‘Organic gene therapy‘ could be effective treatment approach for serious blood disorders
News-Medical.net Genome therapy with beneficial natural mutation could lead to new treatment for life-threatening blood disorders. By introducing a beneficial natural mutation into blood cells using the gene-editing technique CRISPR, a UNSW Sydney-led team of … |
Asbestos.com (blog) |
Mesothelioma Survivor Rising with Immunotherapy
Asbestos.com (blog) Hartline, who was first diagnosed in July 2016, has been receiving the experimental immunotherapy drug nivolumab – also known by brand name Opdivo – for the last seven months. He returns to Balaraman’s nearby office every two weeks for an hour of IV … |
Toronto Star |
Sick Kids scientists repair genetic errors in mice with muscular dystrophy
Toronto Star Science magazine hailed the gene editing tool, CRISPR, as the breakthrough of the year in 2015. The new research is part of a wave of effort to push CRISPR from its early experimental promise toward real-life therapies. “It’s not just something that … |
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Immunotherapy Moves Into Rare Skin Cancer Type
Curetoday.com Despite being about 40 times less common than melanoma, mortality rates are far higher because it’s so aggressive: About 40 percent of patients will experience a recurrence, and, until the discovery of effective immunotherapy in 2016, more than 30 … |