Clinical Intelligence

TissueGene completes enrollment in phase II TG-C study of in knee osteoarthritis

Thursday, November 15, 2012 08:00 AM

TissueGene, is a Rockville, Md.-based biopharmaceutical company focused on developing novel regenerative therapies, has completed patient enrollment for a U.S. phase II clinical trial of TG-C in patients with severe osteoarthritis of the knee. 

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Protein predicts diabetes risk many years in advance

Wednesday, November 14, 2012 03:05 PM

When a patient is diagnosed with type 2 diabetes, the disease has usually already progressed over several years and damage to areas such as blood vessels and eyes has already taken place. To find a test that indicates who is at risk at an early stage would be valuable, as it would enable preventive treatment to be put in place.

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FDA grants Soligenix Fast Track designation for SGX203 for Crohn's disease

Friday, November 9, 2012 12:44 PM

Soligenix, a development stage biopharmaceutical company based in Princeton, N.J., announced that its drug SGX203, for the treatment of mild-to-moderate pediatric Crohn's disease, has received Fast Track designation from the FDA.

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AcelRx doses first patients in ARX-04 phase II study in pain

Wednesday, November 7, 2012 03:09 PM

AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on the treatment of acute and breakthrough pain, has dosed the first subjects in a phase II, placebo-controlled, dose-finding study of its ARX-04 sufentanil NanoTab product candidate. 

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FDA grants Bayer’s Stivarga NDA priority review

Thursday, November 1, 2012 11:49 AM

Bayer HealthCare and Onyx Pharmaceuticals, a biopharmaceutical company based in South San Francisco, announced today that the FDA has granted priority review to the New Drug Application (NDA) for Stivarga (regorafenib) tablets.

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Keryx initiates phase II study of Zerenex in chronic kidney disease

Thursday, November 1, 2012 10:25 AM

Keryx Biopharmaceuticals, a biopharmaceutical company based in New York, N.Y., has initiated a phase II study of Zerenex (ferric citrate), the company's ferric iron-based phosphate binder drug candidate, in managing serum phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).

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The CenterWatch Monthly, November 2012

Thursday, November 1, 2012 08:00 AM

Keeping potential patients connected to trials

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Prezista receives E.C. approval for young children with HIV-1 infection

Friday, October 26, 2012 10:46 AM

The European Commission (E.C.) has approved Janssen/Cilag International’s 100mg/ml oral suspension of Prezista (darunavir), and the use of darunavir co-administered with low dose ritonavir, for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART)-experienced pediatric patients age three and above, weighing at least 15kg. The drug must be taken in combination with other ARTs.

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Novelos enrolls first patient in solid tumor imaging trial

Thursday, October 25, 2012 09:48 AM

Novelos Therapeutics, a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, announced that the University of Wisconsin Carbone Cancer Center (UWCCC), an oncology research institution, has enrolled the first patient in a phase I/II positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with nine solid tumor types, including triple negative breast, soft tissue sarcoma, colorectal, gastric, head and neck cancer, esophageal, prostate, ovarian and pancreatic.

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Allegro Diagnostics reveals positive results of BronchoGen genomic test for lung cancer

Wednesday, October 24, 2012 11:43 AM

Allegro Diagnostics, a molecular diagnostics company based in Maynard, Mass., released positive results from the AEGIS I (Airway Epithelium Gene Expression In the Diagnosis of Lung Cancer) clinical trial, which demonstrate the diagnostic accuracy of the BronchoGe genomic test in combination with bronchoscopy.

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