February 2008

PharmaNet 2008 Outlook Cut Amid Strong CRO Growth

Friday, February 29, 2008

Contract research organizations (CROs) had a great run in the past year, but PharmaNet Development Group’s weak guidance for 2008, issued on Feb. 28, sent its shares tumbling more than 30%. That raises concerns about a possible pullback for the clinical trials industry following a strong year.

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GVAX Show Antibody Respone in Prostate Cancer

Wednesday, February 27, 2008

Cell Genesys reported positive results from a phase II trial of GVAX for the treatment of prostate cancer. GVAX is a cell vaccine that is also being evaluated for the treatment of leukemia and pancreatic cancer.  The autologous vaccine is made by removing a sample of the patient’s own tumor and coaxing it into producing granulocyte-macrophage colony stimulating factor (GM-CSF). The vaccine is then re-administered into the patient via injection, which initiates a potent immune response against the tumor.

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eClinical Technology News

Thursday, February 21, 2008

  • Cleveland, Ohio-based Datatrak inked an enterprise agreement for at least $800,000, depending on the extent of services required by the client. The agreement is a three-year subscription license with an unnamed pharmaceutical company in Europe. The model is a contracting mechanism for the company’s platform is a separate option to its “trial by trial” model. Datatrak stated its typical “revenue composition” has been 25% for the technology element of an eClinical implementation and 75% for services. “We believe that we will always have the trial-by-trial business model, because this is more appropriate for clients with smaller pipelines. However, for clients with more predictable and larger pipelines, this model provides very predictable research and development costs and eliminates wasted time involved with negotiation and contracting under the trial-by-trial mode,” stated Jeffery Green, Pharm.D., chief executive officer of Datatrak.

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Ketek Hearing Winners and Losers

Wednesday, February 13, 2008

After listening to the Feb. 12 hearing by the House Energy and Commerce’s Subcommittee on Oversight and Investigations probing study fraud and the antibiotic Ketek, one thing is clear: PPD, which monitored the study in question sponsored by Aventis (now Sanofi-Aventis), took the least hits from Congress. And it is also quite clear that many in Congress, including committee staff, don’t seem to understand much about the research process.

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Trial Results for Psoriasis Drug Ustekinumab Hit Mark

Wednesday, February 13, 2008

Centocor reported one year data from a phase III trial of ustekinumab (CNTO-1275), a monoclonal antibody against the p40 subunit of IL-12 and IL-23 for the treatment of moderate to severe plaque psoriasis. This randomized, double-blind, placebo-controlled trial, dubbed PHOENIX-1, enrolled 766 subjects.

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