Tag: FDA
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European Patent Issued for Rare Liver Disease Drug
18 February 2015. Synageva BioPharma Corp., a biopharmaceutical company developing therapies for rare diseases, received a European patent on its treatment for lysosomal acid lipase deficiency, an inherited disease causing severe disruptions and injuries to the liver. The European Patent Office issued patent number EP2613798 B1 on 11 February to inventor Anthony Quinn, Synageva’s chief…
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Thyroid Cancer Drug Approved by FDA
16 February 2015. The U.S. Food and Drug Administration approved on Friday a drug for differentiated thyroid cancers, where the cancer continues to grow despite treatments with radioactive iodine. The drug, lenvatinib, is marketed by Eisai Inc. in Woodcliffe, New Jersey, under the brand name Lenvima. The thyroid gland helps the body regulate metabolism, using…
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FDA Sanctions Not Mentioned in Published Clinical Trials
10 February 2015. An investigation by a New York University journalism professor shows serious violations in clinical trials revealed in Food and Drug Administration inspections are largely not mentioned in reports of those trials in scientific journals. The findings of Charles Seife and his team from NYU’s journalism school were published yesterday in the journal…
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Lung Cancer Antibody Given FDA Breakthrough Tag
2 February 2015. An experimental engineered antibody for treating lung cancer received a breakthrough designation from the U.S. Food and Drug Administration. Genentech, a biotechnology subsidiary of drug maker Roche, says breakthrough status was granted for its cancer immunotherapy code-named MPDL3280A to treat programmed death-ligand 1 or PD-L1 positive non-small cell lung cancer whose disease…
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FDA Approves Novartis Psoriasis Drug
21 January 2015. U.S. Food and Drug Administration approved the biologic drug secukinumab for adults with moderate to severe plaque psoriasis, a common skin disorder. Secukinumab, an antibody designed specifically to address the condition, is marketed by the pharmaceutical company Novartis under the brand name Cosentyx. Plaque psoriasis is the most common type of psoriasis, an…
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FDA Issues Draft Wellness Device Guidance
19 January 2015. The U.S. Food and Drug Administration on Friday released draft guidance defining low-risk general wellness devices that the agency intends to exclude from regulatory oversight. The 8-page document, published on the FDA Web site, will be open for comment for 90 days beginning tomorrow. FDA says it prepared the document to answers…
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FDA Approves Nerve Pathway Device for Obesity
14 January 2015. U.S. Food and Drug Administration today approved a device blocking nerve signals between the brain and stomach to help obese people who have not responded to other weight-loss methods control their appetites and lose weight. The Maestro Rechargeable system approved by FDA is made by medical device maker EnteroMedics Inc. in St.…
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FDA Approves New Influenza Treatment
23 December 2014. The U.S. Food and Drug Administration approved yesterday a drug to treat influenza infections in adults. The treatment, Rapivab, is a small molecule drug made by BioCryst Pharmaceuticals in Durham, North Carolina. BioCryst designs and develops therapies that block enzymes involved in infectious and inflammatory diseases, with a technology that creates synthetic compounds using…
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Trial Testing Biologic Treatment for Hepatitis D
22 December 2014. An intermediate-stage clinical trial testing a biologic treatment made by Eiger BioPharmaceuticals Inc. shows lower hepatitis D virus levels among patients taking the treatment compared to a placebo. The San Carlos, California company says the treatment, called lonafarnib, also received orphan drug status by regulatory authorities in the U.S. and Europe. Hepatitis…
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Juno Therapeutics Raises $265 Million in IPO
19 December 2014. Juno Therapeutics, a biotechnology company spun-off from research labs in Seattle and New York, raised some $265 million yesterday in its initial public stock offering. The Seattle enterprise developing cancer therapies that harness the immune system issued 11 million shares of common stock priced at $24.00, and trades on the Nasdaq exchange…