Clinical Intelligence

Savara's AeroVanc granted Orphan Drug status for MRSA lung infection in CF

Tuesday, November 20, 2012 11:23 AM

The FDA has granted orphan drug status to Savara Pharmaceuticals’ AeroVanc (vancomycin hydrochloride inhalation powder) for the treatment of pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF).

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Abbott announces phase III Hep C program details

Friday, November 16, 2012 02:25 PM

Abbott Laboratories, a global healthcare company, has released details on its phase III hepatitis C registration program following promising results from its phase IIb clinical trial, known as Aviator.

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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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