Clinical Intelligence

Aquapharm Biodiscovery discovers novel antibiotic compound

Monday, August 6, 2012 11:01 AM

Aquapharm Biodiscovery, a Scottish marine biotechnology company, has made a discovery in the development of next-generation antibiotics.

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Array BioPharma’s ARRY-797 meets primary endpoint in osteoarthritis study

Friday, August 3, 2012 12:41 PM

Boulder, Colo.-based Array BioPharma’s phase II study of ARRY-797 met its primary endpoint osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs).

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Pfizer releases top-line data from phase III study of tofacitinib in RA

Friday, August 3, 2012 11:24 AM

Pfizer reported today top-line results from ORAL Start (A3921069), a phase III study of the investigational agent tofacitinib, a novel, oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).

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Auxilium touts top-line data from Xiaflex study in Dupuytren's contracture

Monday, July 30, 2012 11:34 AM

Auxilium Pharmaceuticals, a specialty biopharmaceutical company based in Malvern, Penn., issued positive top-line data from its phase IIIb trial evaluating Xiaflex for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. 

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FDA approves Vascepa for severe hypertriglyceridemia

Friday, July 27, 2012 10:53 AM

The FDA has approved Vascepa (icosapent ethyl) capsules as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG ≥ 500mg/dL), according to Amarin, a Bedminster, N.J.-based biopharmaceutical company focused on cardiovascular health.

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Fast-acting TB drug cocktail shows great promise

Friday, July 27, 2012 10:48 AM

Phase II results from a novel anti-tuberculosis drug cocktail—PA-824, moxifloxacin and pyrazinamide—show the elimination of 99% of the Mycobacterium tuberculosis, the causative agent of tuberculosis (TB), found in patients’ saliva following just two weeks of treatment.

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FDA OKs Rayos for rheumatoid arthiris and more

Friday, July 27, 2012 10:31 AM

The FDA has approved Horizon Pharma’s Rayos (prednisone) delayed-release tablets (1mg, 2mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). 

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Vaccine created from patient white blood cells to target brain tumors

Friday, July 27, 2012 08:13 AM

Researchers at Northwestern Brain Tumor Institute (NBTI) are seeking to understand if a vaccine made from a patient's own blood cells may slow the growth of glioblastoma multiformes (GBM), the most common and aggressive type of primary brain tumor.

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IDX719 receives Fast Track designation for Hep C

Thursday, July 26, 2012 10:29 AM

Idenix Pharmaceuticals, a Cambridge, Mass.-based biopharmaceutical company focused on human viral diseases, has been granted Fast Track designation by the FDA for IDX719 for the treatment of chronic hepatitis C infection (HCV).

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PRA participates in landmark Alzheimer’s prevention trial

Thursday, July 26, 2012 09:52 AM

PRA, a global CRO, is participating in an Alzheimer’s disease study that could lead to treatments delaying or even preventing the emergence of symptoms in people destined to develop the disease because of their genetic background.

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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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