Clinical Intelligence

NASA signs patent license agreement for Atherosclerosis treatment

Monday, December 5, 2011 12:05 PM

NASA has signed a patent license agreement that will allow a California company use of NASA-developed technology that could be used to treat hardened arteries in the heart.

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Celldex initiates phase III Rindopepimut trial

Friday, December 2, 2011 04:52 PM

Celldex Therapeutics has launched a phase III trial of rindopepimut in patients with surgically resected epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, the "ACT IV Study." US investigators have started screening patients for inclusion in the trial that is expected to enroll up to 440 patients internationally to recruit 374 patients with Gross Total Resection (GTR) for the primary analysis. Rindopepimut is a therapeutic cancer vaccine candidate that targets the tumor-specific oncogene EGFRvIII, which confers an enhanced capacity for unregulated tumor growth and which is present in many cancer cell types, but not present at significant levels in normal cells.

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ADVENTRX meets with FDA to review ANX-188

Friday, December 2, 2011 04:23 PM

ADVENTRX Pharmaceuticals met with the FDA to review development plans for ANX-188 (purified poloxamer 188), the company's first-in-class treatment for sickle cell patients experiencing vaso-occlusive crisis.

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FDA approves first generic version of Lipitor

Thursday, December 1, 2011 12:17 PM

The FDA has approved the first generic version of the cholesterol-lowering drug Lipitor.

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PPD shareholders approve merger with The Carlyle Group, Hellman & Friedman

Thursday, December 1, 2011 11:06 AM

PPD has reported that its shareholders have voted to approve the adoption of the agreement and plan of merger, providing for the merger of the company with an entity controlled by affiliates of The Carlyle Group and affiliates of Hellman & Friedman.

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The CenterWatch Monthly, December 2011

Thursday, December 1, 2011 09:46 AM

Canada scrambles to reboot sagging clinical trials market

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BioMarin initiates phase II GALNS study

Wednesday, November 30, 2011 01:09 PM

BioMarin Pharmaceutical has initiated a phase II study for GALNS (N-acetylgalactosamine 6-sulfatase) in patients under five years of age with mucopolysaccharidosis IVA (MPS IVA).

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Omeros unlocks 20% of Class A orphans

Wednesday, November 30, 2011 01:02 PM

Omeros has reported that with its identification of compounds that interact
selectively with each of four additional orphan G protein-coupled receptors (GPCRs) - GPR19, GPR20, GPR31 and GPR141 - it has now unlocked over 20% of the 77 Class A orphans. GPCRs represent the premier family of drug targets, with more than 30% of currently marketed drugs targeting only 46 GPCRs. There are approximately 120 orphan GPCRs, and Omeros is initially targeting Class A orphan GPCRs.

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FDA accepts NDA for myeloma drug

Tuesday, November 29, 2011 11:34 AM

The FDA has accepted Onyx Pharmaceuticals' New Drug Application (NDA)
submission for carfilzomib, a next generation proteasome inhibitor, for the potential treatment of patients with relapsed and refractory multiple myeloma.

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FDA approves Intermezzo to treat insomnia

Monday, November 28, 2011 11:08 AM

The FDA has approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

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