Successful Development of Vaccines
October 10th 2005News broke last week about the initial success of Merck & Co's experimental vaccine to prevent cervical cancer. Gardasil, a genetically engineered vaccine, blocks infection with two types of human papilloma virus, HPV 16 and 18. This development added to the mood of excitement and air of eager anticipation surrounding the 75-minute workshop given by a leading European expert in vaccine trials.
Pharmacovigilance in the EU and under the Clinical Trials Directive
October 10th 2005All is not well in the world of drug safety, it seems. Speakers and delegates expressed serious concerns about the European Union's new pharmacovigilance system. It is creating a huge bureaucratic burden for ethics committees and investigators, important differences exist between each country's interpretation and implementation of the regulations, and uncertainty surrounds the precise responsibilities of each partner in the clinical trial process.
Updates on the new French health law and it's impact on clinical trials.
October 10th 2005Presenters included Jean-Pierre Isal, Consultant, UK; Jean-Marc Husson, Prof, Eur Acad of Pharm Med, France; Astra Zeneca. The system has been changed from the Notification System, established in 1988 to a formal Clinical Trial Authorization, 2004-5.
New Trends in Outsourcing and Offshoring
October 10th 2005It's more than 20 years since outsourcing was used in the pharma industry, but the phenomenon remains as popular as ever. Sponsors continue to invest heavily in product development, but they are spending less and less on internal support staff. India is proving an increasingly attractive location for clinical research organizers.
Company Enters Funding Transaction to Support Acquisition Strategy and International Growth
October 10th 2005etrials Worldwide, Inc., the first company to offer fully integrated, easy-to-use eClinical software for the clinical trial process, and CEA Acquisition Corporation (CEAC.OB), a special purpose acquisition corporation, announced today an agreement to merge the two companies. After completion of the merger, etrials Worldwide will be a wholly owned subsidiary of CEAC and etrials shareholders will own a majority interest in the parent company CEAC, a public reporting company.
Alfacell to Present at Second International Symposium on Malignant Mesothelioma
October 4th 2005The presentation, entitled, "Two ONCONASE® Clinical Trials in MM Patients Evaluated Using the EORTC Prognostic Model," will analyze whether there is a difference in survival between ONCONASE study patients categorized as 'Good' or 'Poor' risk for survival, using European Organization for the Research and Treatment of Cancer (EORTC) prognostic scores.
PAREXEL ANNOUNCES ACQUISITION OF MINORITY INTEREST IN PERCEPTIVE INFORMATICS
August 23rd 2005PAREXEL International Corporation (Nasdaq: PRXL) today announced that on August 22, 2005 it acquired all of the shares held by minority stockholders of Perceptive Informatics, Inc., its information technology subsidiary, and now owns all of the outstanding common stock of Perceptive.