Biogen receives FDA approval for new MS treatment
March 27th 2013FDA approved dimethyl fumarate (Tecfidera, Biogen Idec) capsules for the treatment of adults with relapsing forms of multiple sclerosis (MS), including the most common form, relapsing-remitting multiple sclerosis (RRMS), according to an FDA statement on March 27.
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When it comes to safe and reliable biological medicines, manufacturing matters
March 20th 2013Managed care and hospital decision-makers should consider that biological drugs are different from traditional drugs in terms of their complexity and there is potential for problems to arise when manufacturing is not strictly controlled. Furthermore, biological medicines are more difficult to characterize, produce, and reproduce than most traditional pharmaceuticals. This, in turn, can affect the medicine’s quality, safety, or efficacy, and can ultimately impact the reliability of supply, according to a presentation at the Hematology/Oncology Pharmacy Association’s annual conference in Los Angeles, in March.
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AMCP calls on Congress for prohibition of generic exclusion agreements
March 18th 2013The Academy of Managed Care Pharmacy (AMCP) is urging US House leaders to consider a number of proposals to rein in federal spending on healthcare without compromising the popular programs of Medicare and Medicaid.
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New Jersey compounding pharmacy recalls all products, fearing mold contamination
March 18th 2013Med Prep Consulting, Inc., a compounding pharmacy in Tinton Falls, NJ, is voluntarily recalling all lots of compounded products from its facility for fear of mold contamination, according to an FDA press release.
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Diabetes drugs including exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto) are being evaluated by FDA for a potential link to pancreatitis and precancerous changes of the pancreas.
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FDA approves Lymphoseek Injection for use in lymphatic mapping
March 13th 2013FDA approved (technetium Tc 99m tilmanocept (Lymphoseek, Navidea Biopharmaceuticals) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.
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Niacin ER not recommended for patients at risk for cardiovascular outcomes
March 13th 2013The use of extended-release niacin as an adjunct to statins does not reduce the risk of a heart attack or stroke in patients with pre-existing cardiovascular disease, according to researchers who led the HPS2-THRIVE study. The results of the study were reported at the American College of Cardiology conference in San Francisco on March 9.
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Medication management care transition guide available
March 12th 2013After receiving input from more than 80 institutions across the United States, the American Society of Health Systems Pharmacists (ASHP) and the American Pharmacists Association (APhA) developed a new medication management care transition guide.
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