FDAnews Drug Daily Bulletin

The industry's leading trade group has released a proposal calling on its members to publicly disclose the results of all clinical trial research.

PhRMA members have contributed more than $61 million in aid to the victims of last month's tsunami, the trade association said in a recent statement.

The FDA next month will hold a public meeting to review the status of the Study Data Tabulation Model (SDTM) for clinical trial data submissions and to discuss the agency's experience with and plans for the proposed standard format, which was developed by the Clinical Data Interchange Standards Consortium (CDISC).

The FDA's Pediatric Advisory Committee is convening in February to discuss adverse event reporting for six brand drugs.

Private biopharmaceutical firm Xencor and Chugai Pharmaceutical, the fifth largest pharmaceutical company in Japan in terms of sales, have formed a license and collaboration agreement to create monoclonal antibodies to be used against a proprietary cancer target.

A major technology alliance between Tunisia and Canada was announced during a ceremony attended by representatives of the Tunisia Ministry of Public Health, Jacques Saada, Canadian Minister responsible for the Francophonie, and many distinguished guests.

Chronogen, a drug discovery company developing therapeutics to treat age-dependent diseases has announced an agreement with Sosei, a leading Japanese biopharmaceutical company focused on drug development.

Serenex has signed a master drug discovery agreement with GlaxoSmithKline (GSK), expanding a partnership originally forged a couple years ago.

Locus Pharmaceuticals has entered into a cooperative research and development agreement (CRADA) with the U.S. National Cancer Institute (NCI) to develop novel anticancer therapies using Locus' proprietary, fragment-based, computational technology.

Sepracor has announced the formation of a partnership with Acadia Pharmaceuticals for development of new drug candidates targeted toward treatment of central nervous system (CNS) disorders.

Cornerstone BioPharma has announced the acquisition of the Extendryl family of products from Fleming & Company, Pharmaceuticals, which occurred Jan. 1.

GenVec (GNVC) has received a $10 million one-year contract extension of its HIV vaccine development work with the Vaccine Research Center, part of the NIH's National Institute of Allergy and Infectious Diseases.

The good news keeps coming for Amphora Development, a drug development company based in Durham.