Clinical Intelligence

Regeneron, Bayer initiate phase III SIGHT trial in China

Monday, November 28, 2011 10:30 AM

Regeneron Pharmaceuticals and Bayer HealthCare have initiated a phase III clinical trial evaluating the efficacy and safety of EYLEA (aflibercept) injection in the neovascular form of age-related macular degeneration (wet AMD) in China.

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Boston Scientific's PROMUS Element Stent receives FDA approval

Wednesday, November 23, 2011 10:31 AM

The FDA has approved Boston Scientific's PROMUS Element plus everolimus-eluting platinum chromium coronary stent system, the company's next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent, designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with
the market-leading everolimus drug.  The company plans to begin marketing
the product in the U.S. immediately.

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Bionovo enrolls first patient in phase III Menerba trial

Tuesday, November 22, 2011 02:36 PM

Bionovo has reported that the first patient has now been randomized and will begin dosing in the phase III pivotal clinical trial evaluating the safety and efficacy of two doses of Menerba (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.

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FDA approves EYLEA injection

Monday, November 21, 2011 09:27 AM

The FDA has approved Regeneron Pharmaceuticals' EYLEA (aflibercept) injection for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams (mg) every four weeks (monthly) for the first 12 weeks, followed by 2 mg every eight weeks (2 months).

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FDA approves high dose anti-depressant

Thursday, November 17, 2011 11:45 AM

The FDA has approved IntelGenx' lead product, CPI-300, for patients with Major Depressive Disorder. CPI-300 is a novel, high-strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. CPI-300 is the only single dose 450 mg formulation of Bupropion HCl approved by the FDA.

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Cardica enrolls first patients in MicroCutter study

Thursday, November 17, 2011 11:09 AM

Cardica has enrolled the first patients and discharged from the first two investigative sites in a European clinical study to evaluate its MicroCutter surgical cutting/stapling devices for transections, resections and anastomoses during gastrointestinal surgical procedures.

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POZEN's phase I Co-Rx study shows positive results

Monday, November 14, 2011 01:32 PM

POZEN, a pharmaceutical company, has reported positive results from a phase I study comparing a dose-timing strategy of PA32540 and clopidogrel spaced 10 hours apart as compared to synchronous administration of enteric-coated (EC) omeprazole (40 mg), enteric-coated aspirin (81 mg) and clopidogrel (300 mg loading/75 mg daily).  In the Co-Rx study, PA32540, a novel combination of 325 mg of aspirin and 40 mg immediate-release (IR) omeprazole, when dosed 10 hours apart from clopidogrel, was associated with greater platelet inhibition than synchronous administration of aspirin, clopidogrel and delayed-release omeprazole (46.5% versus 39.3%, respectively, at day 7(95% CI [2.57, 11.91]). These findings are directly relevant to the treatment of patients with gastrointestinal (GI) risk who require dual antiplatelet therapy (DAPT) and gastroprotection.

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Anavex successfully completes phase I Alzheimer's trial

Monday, November 14, 2011 11:17 AM

Anavex Life Sciences has successfully completed its phase I single ascending dose (SAD) clinical trial of ANAVEX 2-73, the company's lead drug candidate for the treatment of Alzheimer's Disease.  ANAVEX 2-73 is the first of a new class of oral drugs being studied to potentially treat AD through disease modification rather than focusing only on symptomatic improvement.

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Pantarhei Bioscience discovers ovarian cancer treatment

Monday, November 14, 2011 10:52 AM

Pantarhei Bioscience, a pharmaceutical company focusing on the development of  treatments in the fields of women’s health and endocrine cancer, has reported the results of an innovative treatment strategy for ovarian cancer. 

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NeuroDerm's Parkinson's trial meets primary endpoints

Wednesday, November 9, 2011 08:24 AM

NeuroDerm has reported the results of a phase I/II safety and pharmacokinetic trial of ND0611, administered as an adjunct therapy to Sinemet-CR, Sinemet or Stalevo, in patients with advanced Parkinson's disease. ND0611 is a proprietary carbidopa liquid formula administered sub-cutaneously via a dermal patch to increase the bioavailability and efficacy of orally- administered levodopa. Results of this study support the continued development of ND0611 for the treatment of Parkinson's disease.

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