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Watson Pharmaceuticals Receives A Complete Response Letter For Its 24-Week Formulation Of TRELSTAR(R) (triptorelin Pamoate) NDA From US FDA
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for TRELSTAR(R) 22.5 mg (triptorelin pamoate for injectable suspension), a 24-week formulation of TRELSTAR(R) for the palliative treatment of advanced prostate cancer. The TRELSTAR(R) NDA was prepared in cooperation with Debiopharm Group, a Swiss-based global biopharmaceutical group of companies.
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Endocrine Society supports policies that prevent the illegal and non-medical uses of steroids
In light of yesterday"s Public Health Advisory from the Food and Drug Administration (FDA) warning consumers to immediately stop using all body-building products that claim to contain steroids or steroid-like substances, The Endocrine Society is re-issuing its Position Statement on Steroid Abuse initially launched in 2008.
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Model For New Generation Of Blood Vessels Challenged
In-growth and new generation of blood vessels, which must take place if a wound is to heal or a tumor is to grow, have been thought to occur through a branching and further growth of a vessel against a chemical gradient of growth factors. Now a research team at Uppsala University and its University Hospital has shown that mechanical forces are considerably more important than was previously thought. The findings, published today in the journal Nature Medicine, open up a new field for developing treatments.
Medical Devices

PPD Confirms Takeda Receives FDA Complete Response For Alogliptin

PPD, Inc. (NASDAQ: PPDI) today announced that Takeda Pharmaceutical Company Limited issued a news release reporting that Takeda Global Research & Development Center, Inc., its wholly-owned U.S. subsidiary, has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for alogliptin. PPD is partnering with Takeda to develop 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. PPD announced on March 6, 2009, that the FDA had 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. PPD


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