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NICE Upholds GlaxoSmithKline Appeal For Advanced Breast Cancer Treatment, Tyverb(R)(lapatinib)
The National Institute for Health and Clinical Excellence (NICE) announced that, following GlaxoSmithKline"s (GSK) appeal, it will reconsider the submission for Tyverb (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive).1 GSK is pleased that NICE"s appeal panel agreed that the draft negative guidance should be reviewed, providing fresh hope for up to 2,000 women in the UK who could benefit from this effective treatment on the NHS.
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Uninsured Account For Nearly One-Fifth Of Emergency Room Visits
Health and Human Services Secretary Kathleen Sebelius released new data from the Nationwide Emergency Department Sample - the largest, all-payer emergency department database in the United States. The Nationwide Emergency Department Sample is designed to help public health experts, policymakers, health care administrators, researchers, journalists and others find the data they need to answer questions about care that occurs in U.S. hospital emergency departments.
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AMT Receives EMEA Orphan Drug Designation For Acute Intermittent Porphyria
Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced that the European Medicines Agency has granted Orphan Drug Designation to AMT"s gene therapy product AMT-021 for the treatment of acute intermittent porphyria (AIP).
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Takeda Receives FDA Complete Response Letter For Alogliptin, An Investigational Treatment For Type 2 Diabetes

Takeda Pharmaceutical Company Limited ("Takeda") announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company"s New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin. As previously announced on March 6, 2009, the FDA informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," the FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that Guidance. The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance. "Takeda will continue to promote key initiatives in order to realize sustained growth from a medium- to long-term perspective," said Takeda President & CEO, Yasuchika Hasegawa. About Takeda Pharmaceutical Company Limited Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. Takeda Pharmaceutical Company Limited


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