Clinical Intelligence

Alzheimer’s plasma biomarker study yields potential for diagnostic blood tests

Friday, March 30, 2012 09:10 AM

Proteome Sciences, in collaboration with the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health and Merck Millipore, has completed its 1,000-sample Alzheimer’s disease (AD) biomarker validation study.

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Paratek, FDA agrees on Special Protocol Assessment for pneumonia study

Wednesday, March 28, 2012 12:51 PM

Paratek Pharmaceuticals has reached agreement with the FDA on its second Special Protocol Assessment (SPA) related to the phase III program design for the company's lead antibiotic candidate, omadacycline (formerly PTK 0796), this time for community-acquired bacterial pneumonia (CABP).

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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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