New system transmits CPE data, credits electronically
April 27th 2012The National Association of Boards of Pharmacy, the Accreditation Council for Pharmacy Education (ACPE), and ACPE providers have teamed up to create the CPE Monitor. This new system will allow for the electronic transmission of continuing pharmacy education data.
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Lower rates of intracranial hemorrhage seen with Pradaxa
April 27th 2012Twice-daily dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) was shown to be associated with lower rates of fatal and traumatic intracranial hemorrhage compared with warfarin, according to the results of a retrospective subanalysis published online, April 5, in Stroke, the Journal of the American Heart Association.
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Innovation to control costs, access to care are top healthcare issues, survey says
April 26th 2012More than 75% of the nation?s opinion leaders believe that the best way to control healthcare costs is through discovering innovative ways to deliver services, according to the new NEHI Innovation Barometer survey.
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Novartis updates Gilenya label to include stronger cardiac warnings after FDA review
April 24th 2012Novartis has agreed with FDA to update US prescribing information on fingolimod (Gilenya) to include updated patient selection parameters based on certain cardiovascular considerations to aid in the identification of candidates for Gilenya.
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FDA issues warning, contraindication for blood pressure medications containing aliskiren
April 20th 2012FDA has issued a Drug Safety Communication (April 20) warning of possible risks when using blood pressure medicines containing aliskiren with angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations are contraindicated in patients with diabetes.
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ADA, EASD issue joint position statement on hyperglycemia treatment for T2DM
April 20th 2012Guidelines for managing elevated blood glucose levels in people with type 2 diabetes mellitus, developed jointly by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), are being published concurrently in the ADA?s journal, April 19 online edition of Diabetes Care and in EASD?s journal, Diabetologia.
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Backlog of ANDAs could be alleviated with passage of generic drug user fee act
April 20th 2012Congressional approval of the bipartisan Generic Drug and Biosimilars User Fee Act could eliminate 90% of the backlog of Abbreviated New Drug Applications by 2017, FDA official Russell Wesdyk, BS, MBA, said in a presentation last month.
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Generic Vancocin prompts industry speculation of FDA practices
April 20th 2012FDA?s approval (April 10) of generic versions of ViroPharma?s antibiotic Vancocin (vancomycin hydrochloride) for the treatment of Clostridium difficile-associated diarrhea, has some industry experts wondering if FDA is trying to speed up the availability of generics or politically favor new company competition in select areas of therapy.
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FDA approves pregnancy category change for insulin detemir injection
April 20th 2012FDA has approved insulin detemir [rDNA origin] injection (Levemir, Novo Nordisk) pregnancy Category B classification, indicating that when used in pregnant women with diabetes, the injection did not increase the risk of harm to the unborn baby.
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FDA approves first quadrivalent flu vaccine
April 20th 2012FDA approved the first 4-strain influenza vaccine live, intranasal (FluMist Quadrivalent, MedImmune) for the prevention of influenza. The vaccine?s 4 strains (2 type-A and 2 type-B lineages) help provide broad protection against circulating influenza A and B.
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