Clinical Intelligence

Sanofi, Regeneron share results for lipid-lowering PCSK9 antibody

Tuesday, March 27, 2012 06:34 AM

Sanofi and Regeneron Pharmaceuticals have reported promising data from two phase II trials with SAR236553/REGN727—an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).

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Clovis completes enrollment in pancreatic cancer LEAP study

Monday, March 26, 2012 03:26 PM

Clovis Oncology, based in Boulder, Colo., has reached the target enrollment of 360 patients in its pivotal LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 in metastatic pancreatic cancer.

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Europe approves Byetta with basal insulin for T2D

Monday, March 26, 2012 02:47 PM

The European Commission has granted Amylin Pharmaceuticals and Eli Lilly marketing authorization for Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin for the treatment of type 2 diabetes (T2D).

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FDA approves Bionomics’ phase I/II ovarian cancer trial

Monday, March 26, 2012 02:19 PM

Bionomics Limited, an international biotech based in Thebarton, Australia, has gained approval from the FDA to proceed with its clinical trial of BNC105 in women with ovarian cancer.

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Pozen reports positive top-line results from two phase II studies of PA32540

Friday, March 23, 2012 04:54 PM

Pozen, a Chapel Hill, N.C.-based pharmaceutical company, released positive top-line results from two pivotal phase III clinical trials of PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40mg) and delayed release aspirin (325 mg).

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FDA approves LINX Reflux Management System

Friday, March 23, 2012 04:38 PM

The FDA has approved the LINX Reflux Management System for people diagnosed with gastroesophageal reflux disease (GERD) and who continue to have chronic symptoms despite the use of maximum medical therapy for the treatment of reflux.

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iBio completes phase I trial of H1N1 vaccine

Friday, March 23, 2012 04:13 PM

Chicago-based biotech iBio has completed its first human trial of iBioLaunch-produced H1N1 influenza vaccine (HAC1) assessing safety, reactogenicity and immunogenicity.

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NIHR and MRC fund cystic fibrosis gene therapy trial

Wednesday, March 21, 2012 11:08 AM

A groundbreaking gene therapy trial for cystic fibrosis (CF) will begin in March, thanks to a $4.9 million grant from National Institute for Health Research (NIHR) and the Medical Research Council (MRC) through the Efficacy and Mechanism Evaluation program.

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FDA approves clinical trial of artificial pancreas

Monday, March 19, 2012 03:46 PM

The FDA has approved the first outpatient artificial pancreas trial in the U.S., which will be funded by JDRF, a global organization focused on type 1 diabetes research.

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Repligen enrolls first patient in phase I trial of Friedreich’s Ataxia

Monday, March 19, 2012 03:20 PM

Waltham, Mass.-based Repligen has enrolled the first patient in a phase I clinical trial of RG2833 in adult patients with Friedreich’s Ataxia (FA)—a debilitating, life-shortening, degenerative neuro-muscular disorder that currently has no treatment.

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