VIVUS, Inc. (Nasdaq: VVUS) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s new drug application (NDA) for its investigational drug, Qnexa®, for the treatment of obesity. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010…
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Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients…
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The U.S. Food and Drug Administration today warned consumers not to purchase or use a product called “Arrow Brand Medicated Oil & Embrocation,” also labeled as “Aceite Medicinal La Flecha (Spanish) or “箭嘜驅風油 (Mandarin).” The product is potentially toxic and contains two substances, methyl salicylate and camphor, which are poisonous when ingested.
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Recent news coverage has consumers concerned about the alarming amount of contaminants, such as pesticides and heavy metals, being found in herbal supplements. NSF International, an independent, not-for-profit public health organization, helps ease these concerns by testing and certifying supplements to ensure they are free of undeclared substances and unacceptable contaminants.
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The world’s largest generic pharmaceutical company is investing £37 million to expand its Stouffville, Ontario production plant.
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Michigan State University researchers are studying the role that statins - lifesavers for tens of millions of Americans trying to lower their cholesterol - play in causing disabling tendon ruptures.
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Today at the 2010 International Microbicides Conference in Pittsburgh, Dezzutti presented the results of tests conducted with five of the most widely used lubricants, chosen from the results of an IRMA web-based survey that collected information on the lubricant preferences of nearly 9,000 men and women from over 100 countries. Dezzutti’s findings indicated that some [...]
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HUYA Bioscience International, a leader in globalizing China’s biopharmaceutical innovation, today announced a strategic partnership with the School of Chinese Materia Medica of the Beijing University of Chinese Medicine (BUCM). As one of a series of collaborations that HUYA has established with China’s leading research and development institutions, the agreement demonstrates HUYA’s visionary commitment to [...]
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Of the more than 38,000 Americans diagnosed with renal cell carcinoma each year, approximately 20 percent have non-clear cell forms of the disease. New findings shows that a non-clear cell form of kidney cancer known as papillary RCC, which accounts for 12 percent of all RCC, responds differently to sunitinib - a standard frontline treatment [...]
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Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter today from Zydus Pharmaceuticals USA, Inc. advising of the filing of an Abbreviated New Drug Application (”ANDA”) for a generic version of Shire’s 1.2g mesalamine delayed release tablets, LIALDA(R).
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