Clinical Intelligence

Bridge BioResearch set to launch trial in chronic ulcers

Friday, January 20, 2012 03:08 PM

Bridge Bioresearch (BBR), based in London, has received approval for a phase IIa trial concerning diabetic foot ulcer treatment with isoniazide.

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FDA lifts hold on Insmed’s Arikace

Friday, January 20, 2012 02:49 PM

The FDA has lifted the clinical hold previously placed on Insmed’s Arikace (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease. However, Insmed is still engaged in discussions with the FDA regarding the clinical hold placed on Arikace in cystic fibrosis (CF) patients with Pseudomonas lung infections.

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Aria Diagnostic launches study of non-invasive prenatal test

Wednesday, January 18, 2012 12:04 PM

As Down syndrome becomes an increasing concern, Aria Diagnostics is launching a comparative study of a non-invasive prenatal test to detect Trisomy 21 (associated with Down synrome) and the standard first-trimester screening test.

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Drug improves survival of colorectal cancer patients

Wednesday, January 18, 2012 12:02 PM

Phase II trial results show investigational drug regorafenib slowed the progression of tumors and lengthened the lives of patients with metastatic colorectal cancer, said Mayo Clinic oncologist Axel Grothey, the U.S. trial’s principal investigator.

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Novel brain tumor vaccine tracks down cancer cells

Wednesday, January 18, 2012 12:01 PM

A phase II clinical trial of a vaccine that will track down tumor stem cells “like a bloodhound” has begun at Wake Forest Baptist Medical Center, one of 20 facilities to participate in the randomized, placebo-controlled study.

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Sinovac begins phase III trial in hand, foot and mouth disease

Friday, January 13, 2012 12:14 PM

Sinovac, a provider of biopharmaceutical products in China, has commenced a phase III clinical trial for its proprietary inactivated EV71 vaccine against hand, foot and mouth disease (HFMD).

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Pharmos doses first patients in phase IIa gout trial

Friday, January 13, 2012 12:11 PM

Pharmos has dosed its first U.S. patients with its compound levotofisopam (S-tofisopam) to treat hyperuricemia and gout. As a phase IIa proof-of-concept trial, the trial is designed to assess the safety and efficiacy of levotofisopam as a uric acid-lowering agent.

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Lexicon’s LX411 enhances DPP-4 inhibitor in type 2 diabetics

Friday, January 13, 2012 12:09 PM

LX4211, a novel sodium glucose transporter 1 and 2 (SGLT1 and SGLT2) inhibitor, was proven to enhance the affects of widely prescribed diabetes drug sitagliptin, a DDP-4 (dipeptidyl peptidase) inhibitor, reported Lexicon Pharmaceuticals.

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Morphotek to acquire samples from Fox Chase Cancer Center

Wednesday, January 11, 2012 11:13 AM

Morphotek has formed two agreements with Fox Chase Cancer Center to acquire clinical samples essential for the development and validation of companion diagnostic assays. The assays will be used in the identification of patients who will be suitable for treatment with targeted antibody therapeutics currently being developed by Morphotek.

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Giant leap for HIV cure

Wednesday, January 11, 2012 11:09 AM

After 30 years of unsuccessful attempts, an HIV vaccine may be within reach. That’s what scientists at Crucell NV of the Netherlands (a subsidiary of Johnson & Johnson) are saying.

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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