Friday, September 28, 2007
Merck KGaA reported positive long-term results from a phase II trial of Stimuvax for the treatment of non-small cell lung cancer (NSCLC). The drug is a MUC-1 peptide-based liposomal vaccine, for the potential treatment of cancers.
The U.S. House and Senate passed the long awaited FDA Revitalization Act, a five-year renewal of the Prescription Drug User Fee Act of 1992 (PDUFA). PDUFA allows the FDA to collect fees from drug and device companies applying for regulatory approval. That law was set to expire on Sept. 30.
Russian CRO Synergy Research Group (SynRG) has made its next move to create a global CRO alliance, forming a partnership with Neeman Medical International, an India-based CRO. The alliance will focus on providing international sponsors with monitoring and site and data management services. Neeman Medical was founded in 2001 and is headquartered in New Delhi.
Atherogenics reported positive results from a phase III trial of succinobucol (AGI-1067), an antioxidant oral vascular cell adhesion molecule-1 (VCAM-1) gene expression inhibitor, for the treatment of diabetes and coronary heart disease. This trial, dubbed ARISE (Aggressive Reduction of Inflammation Stops Events), enrolled over 6,000 subjects internationally. Results were reported at the European Society of Cardiology Congress 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.