News

FDA Commissioner resigns just months after taking on the position.

Tool Co-Developed with Lincoln Technologies and FDA Helps Agency to Assess the Safety of Drugs

Biopharmaceutical firm expands usage of Prism® to additional studies to facilitate real-time data capture and analysis

Javelin Pharmaceuticals, Inc. (OTC BB: JVPH) has named Curtis Wright, IV, MD, MPH as Vice President of Risk Management and Regulatory Affairs.

Quicker approval of new drugs by the U.S. Food and Drug Administration (FDA) has not increased the number of prescription drugs withdrawn for safety reasons in this country, according to an analysis recently completed by the Tufts Center for the Study of Drug Development.

Immusol will characterize the biological activity of such ingredients using its proprietary assays for oncology, infectious disease, and other disease areas.

Toby Jane Hindin, EdD, M.Ed. MS

The new 3-year manufacturing and supply agreement is effective as of January 1, 2005.

Targeted Replacement Therapy for Growth Failure in Children With Low Blood Levels of the Hormone IGF-1

Galt Associates (Sterling, VA) has brought together the original Halo web-based safety research and monitoring environment with its dsNavigator search engine for a new and improved Halo platform. Featuring streamlined yet powerful querying capabilities, the platform offers ready access to a vast array of information sources-including FDA and WHO datasets-while a sophisticated interface gives safety professionals automated tools and an intuitive way to manage and analyze data.

Thoughtful application of eDiaries can make clinical development much more efficient.

This newly updated reference guide addresses the most difficult, emerging, and frequently asked GCP questions today.

Acquisition Significantly Expands Clinical Trial Material Supply Capabilities and Customer Support, Jumps Aptuit to Largest Global Provider by Capacity

Eisai's decision is based on Phase II study results that showed a reduction in mortality in eritoran-treated patients versus placebo.

PAREXEL 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.

Clinical Supplies Management Inc. (CSM) in Fargo, North Dakota has established a cross-continent relationship with leading UK outsource services provider Brecon Pharmaceuticals Ltd.

Covance Inc. (NYSE: CVD http://rd.bcentral.com/?ID=3182929&s=81101478) added to its Phase I capacity and further enhanced its reputation for clinical excellence with the purchase today of GFI Clinical Services from West Pharmaceutical Services, Inc. (NYSE: WST).

Three new customers, including Morphotek Inc., Vitae Pharmaceuticals, Inc. and a medical device subsidiary of a top pharmaceutical conglomerate, signed agreements in July with Phoenix Data Systems to use the company's electronic data capture solutions.

Company Enters Funding Transaction to Support Acquisition Strategy and International Growth.

Dedicated Business Unit Responds to Unmet Need

The Taipei, Taiwan-headquartered biotechnology and pharmaceutical company is now looking for international licensing partners to take the herbal-based product on to further clinical trials and subsequent commercialization.

The closing of the transaction is expected to occur in the third quarter, subject to satisfaction of customary closing conditions, including the regulatory approvals.

Studies Presented at 20th Congress of International Society on Thrombosis and Haemostasis

ICTS Introduces Patient Recruitment Training For Study Coordinators

The European Medicines Agency (EMEA) has launched a six-month consultation period on a draft guideline on the conduct of pharmacovigilance for medicines used by the paediatric population, children from birth to 18 years of age.

MeadWestvaco Corporation announces that its Shellpak™ healthcare packaging solution has received a DuPont Silver Award for Innovation in Packaging.

Company continues to pioneer new technology and make clinical trials safer, more accurate and efficient.

Newest version of Propack Data PMX MES validation-ready software provides on-demand manufacturing information to help improve productivity, compliance and speed-to-market.

The decision to terminate the partnership follows the recent release of results from Advancis' Amoxicillin PULSYS Phase III clinical trials.

Oxford BioMedica (LSE: OXB), the leading gene therapy company, announced today that the first stage of its Phase II trial in pancreatic cancer with MetXia, the Company's gene targeted prodrug activation product, has been successfully completed.