Clinical Intelligence

Telik receives Orphan status for Telintra for myelodysplastic syndrome

Monday, January 14, 2013 09:42 AM

Telik, a clinical stage drug development company focused on developing small molecule drugs to treat cancer, was notified today that its product candidate, ezatiostat HCL (Telintra), has been granted Orphan Drug designation by the FDA for the treatment of myelodysplastic syndrome (MDS). 

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KaloBios initiates phase II study with KB001-A in cystic fibrosis

Friday, January 11, 2013 12:10 PM

KaloBios Pharmaceuticals, a biopharmaceutical company based in San Francisco, Calif., has initiated dosing in a randomized, double-blind, placebo-controlled phase II clinical trial of KB001-A, the company's anti-PcrV Humaneered, PEGylated monoclonal antibody fragment. The study will investigate the safety and efficacy of intravenously administered KB001-A as a treatment for chronic Pseudomonas aeruginosa (Pa) infection in cystic fibrosis patients.

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CoDa boasts positive results in phase IIb study of Nexagon in chronic venous leg ulcers

Thursday, January 10, 2013 08:00 AM

CoDa Therapeutics, a clinical stage biotechnology company, released positive results from a phase IIb clinical trial of Nexagon in patients with chronic venous leg ulcers, which supports advancing Nexagon into phase III registration trials.

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Kareus initiates phase I trial in Alzheimer's disease

Friday, January 4, 2013 02:51 PM

Kareus Therapeutics, a private biotechnology company focused on unmet treatment of age-related and chronic diseases, has initiated a phase I clinical study following the Investigational New Drug (IND) approval from the FDA for the development of KU-046, a first-in-class disease modifying new chemical entity discovered for the treatment of Alzheimer's disease using Kareus' proprietary bioenergetics and KARLECT platforms.

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Aeterna Zentaris granted SPA for phase III endometrial cancer trial

Friday, January 4, 2013 02:24 PM

The FDA has granted Aeterna Zentaris Special Protocol Assessment (SPA) for an upcoming phase III registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108.

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FDA grants accelerated approval for Sirturo for multi-drug resistant TB

Wednesday, January 2, 2013 03:13 PM

The FDA has granted accelerated approval to Janssen Therapeutics’ Sirturo (bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion.

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FDA approves Eliquis to reduce blood clots non-valvular atrial fibrillation

Wednesday, January 2, 2013 02:48 PM

The FDA has approved Bristol-Myers Squibb and Pfizer’s anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem.

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The CenterWatch Monthly, January 2013

Wednesday, January 2, 2013 01:39 PM

Parexel celebrates 30 years of change, growth

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FDA approves GSK's four-strain seasonal influenza vaccine

Monday, December 17, 2012 04:28 PM

The FDA has approved GlaxoSmithKline’s Fluarix Quadrivalent (influenza virus vaccine) for the immunization of adults and children (three years and older) to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine.

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UMCG initiates enrollment in RENEW trial for severe emphysema

Monday, December 17, 2012 12:31 PM

The University Medical Center Groningen has enrolled and treated the first patients in the FDA-approved RENEW pivotal trial to evaluate the RePneu Lung Volume Reduction Coil (LVRC) in severe emphysema. 

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