Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, reported top-line results from the month 24 readout of the FAME Study…
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GenWay Biotech, Inc. GenWay Clinical Laboratory, San Diego, California, has been awarded an accreditation by the College of American Pathologists (CAP), based on results of a recent onsite inspection. The laboratory’s director was advised of this national recognition and congratulated for the “excellence of the services being provided.” GenWay Biotech Inc…
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The pharmaceutical company Merck on Monday named former CDC head Julie Gerberding as president of the company’s vaccine division, Reuters reports…
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The investigational compound, eritoran tetrasodium (”eritoran,” also known as E5564) appeared to be well tolerated in patients with severe sepsis in a Phase II trial published in the January issue of Critical Care Medicine, the official journal of the Society of Critical Care Medicine, the largest multiprofessional organization dedicated to ensuring excellence and consistency i…
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Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena’s internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss…
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Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz Tablets, 50 mg, 100 mg and 200 mg…
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Cephalon, Inc. (Nasdaq: CEPH) announced that the U.S. Food and Drug Administration (FDA) has extended the action date to March 29, 2010, for its review of the supplemental New Drug Application (sNDA) for NUVIGIL® (armodafinil) Tablets [C-IV]. The sNDA is for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag [...]
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CVS Caremark announced today that it will provide H1N1 flu vaccinations at select CVS/pharmacy locations in the States of Alabama, Illinois, Kansas, Missouri, Pennsylvania and New York as well at MinuteClinic locations in Massachusetts and Connecticut beginning Thursday, December 31.
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The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) seeking marketing approval for Retigabine. In addition, the European Medicines Agency (EMEA) confirmed on November 17, 2009 that the MAA (Marketing Authorization Application) was successfully validated thus enabling the MAA review to commence.
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Biodel, Inc. announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes.
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