ClinPhone Inks Deal with Japanese Pharma

Friday, September 14, 2007

eClinical technology company ClinPhone has secured a contract with Bayer Yakuhin, the Japanese affiliate of Bayer. ClinPhone has been named the company’s preferred supplier of randomization and trial supply management services, specifically using ClinPhone’s Interactive Voice Response System (IVRS) for a phase III trial in Japan. ClinPhone opened its Asia Pacific offices in Melbourne Australia in late 2006 and credits the move for helping land this new contract.

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Medidata Inks Multiple Contracts in August

Monday, September 10, 2007

New York, N.Y.-based eClinical company Medidata Solutions inked a multi-year contract with Copenhagen-based pharmaceutical firm H. Lundbeck to manage more than 10 psychiatric phase II through IV trials. The studies will use Medidata Rave 5.6, set to launch this month. H. Lundbeck stated it chose Medidata’s electronic data capture (EDC) system based on feedback from clinical research associates and site managers.

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Heart Drug Combo Reduces “Flushing”

Friday, September 7, 2007

Merck reported positive results from a phase III trial of Cordaptive for the treatment of dyslipidemia. Cordaptive was shown to lower LDL –or bad — cholesterol and raise HDL — or good — cholesterol, while lowering some of the side effects of such drugs.

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Recent Industry Personnel News

Thursday, September 6, 2007

  • Clinsys Clinical Research appointed Hartmut Schmied, M.D., to vice president, European Operations. He will be based in Dusseldorf, Germany. Prior to Clinsys, Schmied was Medifacts International’s executive director of European Operations and global head of clinical research. He also served in clinical development positions at Bayer AG.

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Cardium’s Heart Drug Shows Mixed Results

Monday, September 3, 2007

Cardium reported mixed results from two phase IIb/III trials of Generx (alferminogene tadenovec, Ad5FGF-4) for the treatment of chronic angina. These randomized, double-blind, placebo-controlled trials were dubbed AGENT (Angiogenic GENe Therapy -3 and -4 and enrolled a total of 532 subjects in the US and Europe.  Subjects received a low dose or high dose of Generx, administered via intracoronary infusion or placebo for 12 weeks. The primary endpoint was the change from baseline in exercise treadmill time (ETT) at 12 weeks and at secondary time points of 4 weeks and 6 months. Secondary endpoints included time to 1 mm ST-segment depression, time to onset of angina and change in Canadian Cardiovascular Society (CCS) class. Pooled data showed no significant difference in the active groups versus placebo in the primary endpoint.

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