Food and Drug Administration (FDA)
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Despite the data concerns, the U.S. Food and Drug Administration said it believes the gene therapy should remain on the market. Novartis said it stands behind the safety and efficacy of the therapy.
The CDC and FDA AR Isolate Bank will provide information to LexaGene which will support the company’s diagnostics development and help address the serious issue of antibiotic resistance.
The approval is for only “select” patients where surgery isn’t an option. It also comes with a Boxed Warning for liver toxicity, which has been a problem in several clinical trials with the drug.
Ultragenyx Pharmaceutical Inc. announced that it has submitted to the U.S. Food and Drug Administration a New Drug Application for UX007 for the treatment of long-chain fatty acid oxidation disorders, a group of genetic disorders in which the body is unable to convert long-chain fatty acids into energy.
Daiichi Sankyo Europe GmbH announced that results from the 12-week, pivotal Phase 3 bempedoic acid / ezetimibe FDC tablet study (also known as Study 053) were published in the European Journal of Preventative Cardiology.
The U.S. Food and Drug Administration approved Bayer’s Nubeqa (darolutamide) for non-metastatic castration-resistant prostate cancer.
The U.S. Food and Drug Administration approved the anti-PD-1 therapy as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 with disease progression after one or more previous lines of systemic therapy.
There were two issues the agency had. First, the FDA wanted the inclusion of two animal studies to evaluate whether the drug caused thickening of the heart valve. The second was more of a goof—the contract research organization Zogenix employed uploaded the wrong data set for the application.
A recent study conducted by the Milbank Quarterly found that the FDA followed the guidelines of the scientific advisory committees 78% of the time. To come to that conclusion, researchers examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015.
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