Clinical Intelligence

Lexicon completes phase II study of LX1033

Thursday, December 5, 2013 09:56 AM

Lexicon Pharmaceuticals has announced top-line results from an initial phase II study exploring the use of LX1033 in diarrhea-predominant irritable bowel syndrome (IBS-d). LX1033 is an investigational drug that inhibits serotonin synthesis in the gastrointestinal tract. Serotonin is a neurotransmitter that has been shown to play a role in the symptoms of irritable bowel syndrome.

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WIRB Copernicus Group

New research shows promise for possible HIV cure

Wednesday, December 4, 2013 02:33 PM

Researchers have used radioimmunotherapy (RIT) to destroy remaining human immunodeficiency virus (HIV)-infected cells in the blood samples of patients treated with antiretroviral therapy, offering the promise of a strategy for curing HIV infection. Results of the study were presented at the annual meeting of the Radiological Society of North America (RSNA).

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CRF Health eCOA webinar series

The CenterWatch Monthly, December 2013

Monday, December 2, 2013 08:01 AM
Summary not available

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Boston Scientific system receives CE Mark approval for Dystonia

Tuesday, November 26, 2013 11:38 AM

The Boston Scientific Vercise Deep Brain Stimulation (DBS) System has received CE Mark approval for the treatment of intractable primary and secondary dystonia, a neurological movement disorder characterized by involuntary muscle contractions.

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Boehringer Ingelheim planning two global trials of Pradaxa

Tuesday, November 26, 2013 10:34 AM

Boehringer Ingelheim Pharmaceuticals plans to initiate two new global clinical trials of PRADAXA. One of the new trials, RE-DUAL PCI (Randomized Evaluation of Dual Therapy with Dabigatran v. Triple Therapy Strategy with Warfarin in Patients with NVAF that have undergone PCI with Stenting), is designed to evaluate the efficacy and safety of PRADAXA in patients with non-valvular atrial fibrillation (NVAF) who have undergone percutaneous coronary intervention (PCI), also known as angioplasty, with stent placement. The second of the new trials, RE-SPECT ESUS(TM) (Randomized Evaluation in Secondary stroke Prevention Comparing the Thrombin inhibitor dabigatran etexilate v. ASA in Embolic Stroke of Undetermined Source), is designed to evaluate the efficacy and safety of PRADAXA as a secondary stroke prevention therapy in patients who have suffered an embolic stroke of undetermined source (ESUS). Embolic strokes occur when a blood clot forms somewhere in the body and travels through the bloodstream to the brain.

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Novocure initiates NovoTTF Therapy trial for brain metastases from NSCLC

Tuesday, November 26, 2013 09:29 AM

Novocure, a privately-held Jersey Isle oncology company, has enrolled the first patients in the EF-21 Study, a prospective randomized clinical study of NovoTTF Therapy for patients with brain metastases from non-small cell lung carcinoma (NSCLC) cancer. NovoTTF Therapy is an anti-mitotic treatment delivered continuously throughout the day by the NovoTTF-100A System.

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Reinforced safety profile of Boehringer Ingelheim’s Pradaxa released

Tuesday, November 19, 2013 01:37 PM

Boehringer Ingelheim Pharmaceuticals has announced results from a new, long-term, combined analysis of the pivotal phase III RE-LY trial and its extension safety study RELY-ABLE. The data showed that after a median follow up of 4.6 years, with some patients followed up to 6.7 years, rates of stroke/systemic embolism and major bleeding were consistent with rates in previously reported analyses of RE-LY, one of the largest stroke prevention clinical studies ever conducted in patients with non-valvular atrial fibrillation (NVAF).

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Isis earns $5 million milestone Payment from GSK

Tuesday, November 19, 2013 12:35 PM

Isis Pharmaceuticals has earned a $5 million milestone payment from GlaxoSmithKline related to the designation of ISIS-GSK4Rx as a development candidate. ISIS-GSK4Rx is an antisense drug designed to treat an undisclosed ocular disease. 

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Lumena Pharmaceuticals receives positive opinion in the E.U. for four rare liver diseases

Tuesday, November 19, 2013 11:33 AM

Lumena Pharmaceuticals, a San Diego-based based company developing oral therapeutics for rare liver diseases, has received positive opinions for four Orphan Drug designations by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for LUM001. The company's lead drug candidate, LUM001, received the first positive opinion granted by the EMA for primary sclerosing cholangitis (PSC). In addition, the company received positive opinions for LUM001 in three other rare cholestatic liver diseases, including Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and primary biliary cirrhosis (PBC). This follows the Orphan Drug Designation in September by the FDA Office of Orphan Product Development for LUM001 in the same indications.

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Study finds children born prematurely face higher risk of retinal detachment

Wednesday, November 13, 2013 04:40 PM

Children born extremely prematurely have up to a 19 times greater risk of retinal detachment later in life than peers born at term, according to a Swedish study published this month in Ophthalmology, the journal of the American Academy of Ophthalmology. In the first large population-based, long-term investigation of the association between preterm birth and later retinal detachment, the research determined that birth before 32 weeks is associated with increased risks of retinal detachment in childhood, adolescence and young adult life. The study's findings indicate the need for ophthalmologic follow-up in children and adults born extremely and very prematurely. The U.S. has the sixth largest number of premature births, with more than 500,000 premature babies born each year.

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