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Multiple Sclerosis Treatemnt Receives Fast Track Designation Form FDA
BioMS Medical, a leading developer in the treatment of multiple sclerosis (MS), has announced that FDA has granted fast track designation for the Company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS).
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MorphoSys Announces Publication of First MOR103 Data
MorphoSys announced today the publication of a first data package for its most advanced proprietary drug development program MOR103, a fully human HuCAL antibody directed against GM-CSF, in the journal "Molecular Immunology".
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New Institute to Study Obesity, Diabetes and Other Metabolic Disorders
A new centre has opened to address the growing threat to public health posed by obesity, diabetes and related diseases. The University of Cambridge, the Medical Research Council and Cambridge University Hospitals NHS Foundation Trust have joined forces to create the unique, innovative Institute of Metabolic Science (IMS).
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XDx’s AlloMap® Gene Expression Test Cleared by FDA
XDx, Inc. based in Brisbane, California has received market clearance from the U.S. Food and Drug Administration (FDA) for AlloMap® Molecular Expression Testing.
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Novavax announces favourable results from PhaseI/IIa Pandemic Influenza Vaccine Program
Novavax, Inc. announced today favorable results from the second stage of the Phase I/IIa human clinical trial of its pandemic
influenza virus-like particle (VLP) vaccine candidate. The vaccine, which does not contain an adjuvant, induced robust neutralizing antibody responses. Novavax's VLP candidate is directed against the H5N1 A/Indonesia/05/2005 avian influenza strain.
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Exploratory Clinical Development World Americas 08, Philadelphia, PA, USA
23 September 2008 - 25 September 2008
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Global Clinical Trial Operations, San Diego, CA, USA
25 September 2008 - 26 September 2008
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Paediatric Drug Development and Clinical Trials, Brussels, Belgium
30 September 2008 - 01 October 2008
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Conducting Clinical Trials in Europe, Frankfurt, Germany
06 October 2008 - 08 October 2008
The event, being held in Germany later this year, will cover regulatory developments in the European environment whilst paying close attention to the recent inclusion of paediatric studies for all clinical trials. It will also cover various aspects of patient recruitment and retention and will analyse key logistical challenges.
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Clinical Trial Supply USA East Coast, Philadelphia, USA
21 October 2008 - 22 October 2008
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Partnerships in Clinical Trials 2008, Berlin, Germany
04 November 2008 - 07 November 2008
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Quantifying the Impact of a Drug on Gastric Emptying: Measuring the Pharmacodynamic Effect in Clinical Trials
Pharmaceutical Profiles Ltd
Many drug classes are known to alter the rate of gastric emptying. Whilst there is no specific regulatory guidance requiring the impact of drugs on GE to be measured, it is important to fully understand the mode of action and the relationship between the pharmacokinetic profile and the pharmacodynamic response.
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Building Flexibility ino Phase I Protocols and Early Clinical Development Programs
Pharmaceutical Profiles
The transition of a drug candidate into Phase I and other early drug development programs is undergoing considerable examination and change. This has largely been brought about by commercial and scientific drivers to reduce attrition rates coupled with an evolving regulatory environment, all of which encourage the pharmaceutical industry to build both scientific focus and flexibility into the drug development program.
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RNAi Therapeutics 2008
Published November 2007
This is the latest RNAi-based Therapeutics Market Report from Select Biosciences. This report presents an up-to-date thorough analysis of the RNAi therapeutics landscape based upon our continuing coverage of this dynamic marketplace. This report presents an exhaustive analysis of all the therapeutics areas where research efforts using RNAi-based therapeutics are being focused: From Research/Pre-Clinical through Phase III Clinical Trials. Select Biosciences proprietary market survey addresses dru
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Cancer Personalized Medicine 2008
Published July 2008
The Cancer Personalized Medicine marketplace represents the paradigm for personalized medicine market evolution and Select Biosciences focuses in this report on the various commercialized cancer predictor tests, their current status, traction in the marketplace, quantitative market opportunities, and the factors that are driving as well as challenging the expansion of this space. Personalized Medicine, especially as it relates to Cancer, is undergoing significant growth and this report focuses i
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