The News Review:

- Exenatide Clinical Data Analysis Shows No Increased Risk of …
- Lawmakers Detail Medical Research Sting: Company Was a Real Dog
- Cardium Reports on Recent Highlights Financial Results and 2009 …
- Kendle Senior Scientist Edward Sellers MD PhD Named ne of Nine …

Exenatide Clinical Data Analysis Shows No Increased Risk of …
FXBusiness
This finding suggests there is no increased risk of exenatide on cardiovascular outcomes and will be used to support the cardiovascular safety of exenatide once weekly a phase 3 investigational formulation of exenatide the active ingredient in BYETTA. To determine if there are favorable cardiovascular effects of exenatide treatment Lilly and Amylin intend to initiate a large cardiovascular outcomes trial with a superiority design that will evaluate the effects of exenatide once weekly on major cardiovascular events compared to standard of care with traditional antidiabetes medications. The global study will be sponsored by Amylin and Lilly and active discussions are ongoing to have the study led by two academic research centers The Diabetes Trial Unit at the xford Centre for Diabetes (xford England) and Duke Clinical Research Institute at Duke University (Durham N. The steering committee for this study is chaired by Professor Rury Holman FRCP director Diabetes Trial Unit xford University and Robert M.

Lawmakers Detail Medical Research Sting: Company Was a Real Dog
Wall Street Journal Blogs
A congressional committee’s sting operation into medical research – one that included a fake company with a fake surgical adhesive to be used in a fake clinical trial – was detailed this morning at a House Energy and Commerce Committee hearing. The hearing focused on the need for more oversight by and of institutional review boards empowered by regulators to decide whether planned clinical research involving humans should be allowed to go ahead. The tale of the surgical adhesive has already been aired in a news release by the IRB in question — Coast IRB of Colorado — which approved the clinical trial five months before learning that the company. Both were created as part of the House committee’s.

Cardium Reports on Recent Highlights Financial Results and 2009 …
FXBusiness
Consistent with Cardium’s business strategy the Company believes that InnerCool has reached a significant valuation inflection point within Cardium’s investment portfolio and with the appropriate strategic positioning best-in-class products and a pipeline of innovative product opportunities Cardium intends to advance InnerCool’s therapeutic cooling and warming products into corresponding markets through the strategic sale of the business to a large and diversified medical device company or through various vertical partnering opportunities with established companies having existing sales and marketing organizations but with a continuing need for innovative high-value content products. The Company believes this strategy is more cost-effective than building InnerCool into a fully integrated manufacturing sales and marketing organization. Recent highlights and ongoing product development and clinical research activities at InnerCool include the following: — U. Food and Drug Administration (FDA) 510(k) clearance to market the RapidBlue(TM) System an endovascular temperature modulation device. The new RapidBlue System is believed to be the most powerful easy to use endovascular-based system available. InnerCool has obtained CE mark approval and Underwriters Laboratories Inc.

Kendle Senior Scientist Edward Sellers MD PhD Named ne of Nine …
FXBusiness
Regulatory Consulting and Submissions was chosen based on his work in innovative trial design. About Kendle Kendle International Inc. (Nasdaq: KNDL) is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world’s biopharmaceutical industry. ur focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing drugs to market for the benefit of patients worldwide. As one of the fastest-growing global providers of Phase I-IV services we offer experience spanning more than 100 countries along with industry-leading patient access and retention capabilities and broad therapeutic expertise to meet our customers’ clinical development challenges. Kendle was recognized by FRTUNE magazine as one of the 100 fastest- growing companies in the United States for 2008. The company also has been recognized as the “Top CR to Work With” in the CenterWatch 2007 survey of U.
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