Clinical Intelligence

Circadian launches phase I cancer trial

Monday, January 9, 2012 01:59 PM

Circadian Technologies, a biologic drug developer, has launched the first phase I clinical trial of VGX-100, its fully human monoclonal antibody against the human VEGF-C protein.

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Pfizer initiates phase I trial for Hemophilia drug

Monday, January 9, 2012 09:36 AM

Pfizer has initiated a phase I clinical trial for PF-05280602, an engineered variant of recombinant human Factor VIIa developed by Catalyst Biosciences.

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Apogenix receives grant to commence phase II trial

Monday, January 9, 2012 09:32 AM

Apogenix, a biopharmaceutical company based in Heidelberg, Germany, received a $3 million BMBF grant (German Federal Ministry of Education and Research) as partner of the Biotech Cluster Ryine-Neckar. The grant will be used to further advance the company’s lead substance APG101, a fully human protein that aids in treating solid tumors, such as glioblastoma multiforme (GBM).

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Results of OncoGenex phase I/II Custirsen trial published

Friday, January 6, 2012 09:32 AM

OncoGenex Pharmaceuticals has reported results of a phase I/II study to determine the effectiveness of its investigational compound custirsen in conjunction with a gemcitabine/platinum-based regimen in patients with advanced non-small cell lung cancer (NSCLC).

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The CenterWatch Monthly, January 2012

Tuesday, January 3, 2012 11:06 AM

Site landscape shrinking, losing most active PIs

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Eisai resubmits Perampanel NDA to FDA

Tuesday, December 27, 2011 01:28 PM

Eisai has resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the FDA. This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of some datasets in the dossier. The application was originally submitted in May 2011.

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FDA reviews NDA for VIVUS' Qnexa

Tuesday, December 27, 2011 11:11 AM

VIVUS has reported that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012. VIVUS resubmitted the NDA on seeking approval to market Qnexa in the United States. The FDA has accepted the NDA for review. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.

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Chelsea Therapeutics' phase II Droxidopa trial meets primary endpoint

Friday, December 23, 2011 11:01 AM

Chelsea Therapeutics International has reported results of a phase II dose-finding study designed to evaluate the safety and determine the potential therapeutic dose range of droxidopa, alone or in combination with carbidopa, that might be effective for the treatment of fibromyalgia.

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Alkermes initiates phase III ALKS 9070 study for schizophrenia

Monday, December 19, 2011 01:42 PM

Alkermes has initiated a phase III clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070 is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY for the treatment of a number of central nervous system (CNS) disorders.

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Isis initates phase I spinal muscular atrophy study

Monday, December 19, 2011 11:34 AM

Isis Pharmaceuticals has initiated a phase I study of ISIS-SMNRx in patients with spinal muscular atrophy (SMA).  SMA is a severe motor-neuron disease that is the leading genetic cause of infant mortality. Isis is developing ISIS-SMNRx as a potential treatment for all types of SMA.

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