United States

FDA approves first drug-eluting coronary stents

Monday, February 27, 2012 10:06 AM

The FDA has approved Boston Scientific’s Ion Paclitaxel-Eluting Platinum Chromium Coronary Stent System and Taxus Liberte Paclitaxel-Eluting Coronary Stent System for use in patients experiencing an acute myocardial infarction (AMI), or heart attack. 

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FDA advisory committee recommends Qnexa for approval

Monday, February 27, 2012 10:03 AM

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended Vivus’ adult obesity drug Qnexa be granted marketing approval by the FDA.

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Verinata study published in Obstetrics & Gynecology journal

Monday, February 27, 2012 10:01 AM

Obstetrics & Gynecology (Green journal) published full data from Verinata Health’s prospective, blinded, multi-center clinical validation study to detect fetal chromosomal aneuploidies across the entire genome using its verifi prenatal test.

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NW Bio opens 30 trial sites ahead of schedule

Monday, February 27, 2012 09:50 AM

Northwest Biotherapeutics (NW Bio) now has 30 clinical trial sites open and recruiting across the U.S. in its ongoing phase II clinical trial of DCVaxR-L immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. 

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Axxiem to release portal solution AxxiTRIALS 2.0

Monday, February 27, 2012 09:48 AM

Axxiem Web Solutions will debut AxxiTRIALS 2.0, the latest release of its clinical trials community portal solution, on March 5, 2012.

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FDA approves first-ever med for Cushing’s syndrome

Friday, February 24, 2012 11:14 AM

The FDA has approved Korlym (mifepristone) 300mg tablets as a once-daily oral medicine to control hyperglycemia secondary to hypercorisolism in adults with endogenous Cushing’s syndrome, according to Corcept Therapeutics.

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Positive phase IIb results in Threshold pancreatic cancer trial

Friday, February 24, 2012 11:13 AM

Threshold Pharmaceuticals’ TH-302 combination phase IIb study for pancreatic cancer has reached its primary endpoint with a 63% improvement in progression free survival and a safety profile consistent with previous studies.

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Premier Research expands in Salt Lake City and Phoenix

Thursday, February 23, 2012 02:39 PM

CRO Premier Research Group is opening state-of-the-art clinical research facilities in Phoenix, Ariz., and Salt Lake City, Utah, increasing its testing facilities capacity by 50%.
 
“We are excited to be expanding our existing clinical research facilities to accommodate more phase I and outpatient studies,” stated Michael Kuss, vice president, analgesia, Premier Research.

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FDA to bolster supply of critically needed cancer drugs

Wednesday, February 22, 2012 02:03 PM

The FDA has announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. 

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Enanta, Novartis collaborate to advance Hep C inhibitor

Wednesday, February 22, 2012 01:53 PM

Enanta Pharmaceuticals, a developer of best-in-class small molecule drugs in the infectious disease field, has formed an exclusive collaboration and license agreement with Novartis for the worldwide development, manufacture and commercialization of its lead development candidate, EDP-239, a hepatitis C virus inhibitor.

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