Clinical Intelligence

Janssen’s Nucynta meets primary endpoint in diabetic peripheral neuropathy study

Monday, May 21, 2012 02:46 PM

Janssen Pharmaceuticals has issued results from an investigational phase III study suggesting Nucynta ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy (DPN).

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Pharmos' levotofisopam trial in gout earns positive results

Friday, May 18, 2012 12:52 PM

Pharmos, a biopharmaceutical company based in Iselin, N.J., has successfully completed a proof-of-concept clinical trial using its compound levotofisopam (S-tofisopam) to treat patients with hyperuricemia and gout.

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City of Hope finds potential cure for type 1 diabetes

Friday, May 18, 2012 10:11 AM

City of Hope, a research, treatment and education center for cancer, diabetes and other life-threatening diseases based in Duarte, Calif., has developed a combination therapy to treat late-stage type 1 diabetes (T1D) that appears to offer a potential lifetime cure for the disease without toxic side effects. The laboratory study was published in the May 9, 2012, edition of Science Translational Medicine.

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Elevation Pharma releases positive phase IIb results in COPD

Thursday, May 17, 2012 10:31 AM

Elevation Pharmaceuticals, a San Diego-based company focused on the development of new aerosol therapies, has released positive results from a phase IIb study of EP-101 in patients with chronic obstructive pulmonary disease (COPD), a progressive disease of chronic bronchitis and emphysema.

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Achillion receives Fast Track for Hep C drug

Thursday, May 17, 2012 10:15 AM

The FDA has granted Fast Track designation to Achillion Pharmaceuticals’ ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV).

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The CenterWatch Monthly, May 2012

Tuesday, May 1, 2012 08:00 AM

Newer sites most optimistic about the future

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Baxter reports positive phase III results for Gammagard Liquid

Monday, April 30, 2012 04:02 PM

Baxter International, a healthcare company based in Deerfield, Ill., has released results from its phase III clinical trial evaluating Gammagard Liquid 10% (Immune Globulin Infusion (Human)) for the treatment of multifocal motor neuropathy (MMN).

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FDA approves Stendra for ED

Monday, April 30, 2012 03:45 PM

The FDA has approved Stendra (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S., according to biopharmaceutical company Vivus.

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Actelion's macitentan meets primary endpoint in phase III PAH study

Monday, April 30, 2012 12:10 PM

Switzerland-based Actelion Pharmaceuticals' initial analysis indicates that the pivotal, long-term phase III SERAPHIN study with macitentan, a novel dual endothelin receptor antagonist, has met its primary endpoint.

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Pharmanest initiates phase I SHACT trial

Monday, April 30, 2012 11:45 AM

Pharmanest, a Stockholm-based pharmaceutical company, has dosed its first patient has in an open label pharmacokinetic phase I study with its drug candidate SHACT, a product developed for pain relief in connection with intrauterine device (IUD) insertion.

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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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