Clinical Intelligence

ZALTRAP trial recommended for advancement

Friday, July 8, 2011 12:58 PM

Regeneron Pharmaceuticals has announced that its phase III VENICE clinical trial evaluating the investigational agent ZALTRAP (aflibercept) in the first-line treatment of patients with androgen-independent (hormone-refractory) metastatic prostate cancer will continue to completion as planned, with no modifications due to efficacy or to safety concerns.  This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis.

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Pharmasset, Tibotec collaborate in hepatitis C study

Friday, July 8, 2011 12:32 PM

Pharmasset has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate in a phase II study the safety and efficacy of PSI-7977 in combination with TMC435, for the treatment of chronic hepatitis C virus (HCV).

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Generex reports results of two diabetes trials

Friday, July 8, 2011 12:30 PM

Generex Biotechnology announced preliminary clinical results of two major trials using the Generex Oral-lyn formulation that will be used for registration and marketing. 

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Novartis phase III trial meets primary endpoint

Friday, July 8, 2011 12:26 PM

Novartis announced phase III trial results that showed more than one-third of patients taking AfinitorR (everolimus) tablets experienced a 50% or greater reduction in the size of their subependymal giant cell astrocytomas (SEGAs), non-cancerous brain tumors associated with tuberous sclerosis complex (TSC).

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Anavex continues ANAVEX 2-73 phase I trial

Friday, July 8, 2011 12:24 PM

Anavex Life Sciences has commenced the 30mg dose step in its ongoing phase I clinical trial to evaluate ANAVEX 2-73, a drug candidate for Alzheimer's disease. This is the third of six potential dose steps and follows the successful completion of the 1mg and 10mg dosing rounds.  There have been no adverse effects recorded to date.

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Study results support BYDUREON’s NDA

Friday, July 8, 2011 12:21 PM

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced results from QT (tQT) study of exenatide to increase the QT interval across a wide range of plasma concentrations. The study was conducted to satisfy a requirement by the FDA in support of the New Drug Application (NDA) for BYDUREON (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

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Almac to deliver results of AclarusDx test

Wednesday, July 6, 2011 10:05 AM

Almac’s Diagnostics will be the central service lab to perform the analytic phase and deliver to the clinicians the result of Exonhit AclarusDx diagnostic test.

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FDA approves first LazandaR nasal spray

Wednesday, July 6, 2011 10:03 AM

Archimedes Pharma and its subsidiary, Archimedes Pharma U.S., have won FDA approval of LazandaR (fentanyl) nasal spray for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.

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Complete Genomics introduces new grant program

Tuesday, July 5, 2011 12:13 PM

Complete Genomics, a human genome sequencing company, has announced a new cancer grant program. Winning research applications will receive complete human genome sequencing of eight genomes—four tumor/normal pairs. Four winning entries will be chosen: two each from the United States and Europe.

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The CenterWatch Monthly, July 2011

Friday, July 1, 2011 02:31 PM

Sponsors question variations in overhead rates

Few issues provoke more interest in clinical trial grant negotiations than the contract’s overhead rate. The range in overhead rates charged among investigative sites can leave sponsors baffled; while some independent physician-run sites ask for no overhead at all, a few top academic institutions request up to 70%. Historically, sponsor companies have paid requested overhead rates without question. Yet as sponsors have looked for ways to...

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