Prescription Drugs 2 Go

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA). The revised action date is the result of the FDA’s decision to allow five additional days for its review of pending regulatory applications following the agency’s recent five-day weather-related closure… (Source: Health News from Medical News Today)

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The snow storms that slammed the mid-Atlantic region this month shut down government agencies around Washington, D.C., long enough for the U.S. Food and Drug Administration to delay its review of Alkermes Inc.’s new drug application for diabetes therapy exenatide. (Source: bizjournals.com Health Care:Biotechnology headlines)

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA)… (Source: Diabetes News From Medical News Today)

Source: PharmaTimes
Area: News
PharmaTimes reports that the once weekly glucagon-like peptide-1 (GLP-1) analogue taspoglutide has shown positive results in five phase III trials and the company have suggested that it could be a valuable treatment for people with type 2 diabetes. The drug is licensed to Roche from Ipsen. The phase III trials (called T-emerge trials) found that taspoglutide met the primary end-points of reduction in blood glucose (no further detail in PharmaTimes story). The trials compared the drug with current standards of care including: insulin glargine, sitagliptin and exenatide. …

Diabetes Technology & Therapeutics Mar 2010, Vol. 12, No. 3: 233-240. (Source: Diabetes Technology)

Source: NICE
Area: News
NICE has been asked to produce guidance on the use of liraglutide for the treatment of type 2 diabetes mellitus in the NHS in England and Wales.  The Appraisal Committee has issued an Appraisal Consultation Document (ACD), which includes the following preliminary recommendations:
 
. Liraglutide 1.2 mg daily in triple therapy regimens (in combination with metformin and a sulfonylurea, or metformin and a thiazolidinedione) is recommended as an option for the treatment of people with type 2 diabetes mellitus, only if used as described for exenatide in …

Authors: Dandona P, Chaudhuri A, Dhindsa S
PMID: 20154655 [PubMed - in process] (Source: American Journal of Hypertension)

Updated Date: Feb 24, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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Conclusion: Further research on the effects of exenatide treatment on energy intake and expenditure are recommended to better understand the mechanisms through which exenatide causes weight loss. (Source: Nutrition)

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No Abstract. (Source: Practical Diabetes International)