For example, the agency has established a web-based system in which firms can submit clinical trial information electronically...On The Move In Washington When Carl Feldbaum, president of the Biotechnology Industry Organization, announced his plan to retire this year at age 60, he told BioWorld Today 2004 will be a good year to recruit new talent because high-caliber, high-profile political people often change jobs in an election year. (See BioWorld Today, Feb. 3, 2003.) Indeed, while Feldbaum's

The Biotechnology Industry Organization (BIO) said the "forward-looking" report acknowledges the need for flexibility in the regulatory framework...law, the agency said.

The European biotechnology industry greeted the minister's announcement with enthusiasm...And while "the empirical and clinical approach continues to play a determining role" in life sciences research, "we know, too, that further progress can be expected in this area from work often of a very basic nature in the field of genomics and the neurosciences

BioShield made it through the House in a lopsided 421-2 vote in July, but it never got through the Senate. (See BioWorld Today, March 28, 2003; April 7, 2003; and July 23, 2003.) In a speech before the Chemical and Biological Arms Control Institute last week on behalf of the Biotechnology Industry Organization, Una Ryan, president and CEO of Avant Immunotherapeutics Inc...Bush Gives FDA Authority On Pediatric Trials President Bush signed legislation authorizing the FDA to force drug companies to

And EuropaBio, the European biotechnology industry association, is similarly arguing that comparability rules of generics and biological medicinal products "should be strengthened to guarantee patient safety and to avoid confusion and legal inconsistencies where biosimilar medicines are concerned...If that creates competition among member states for the most effective fostering framework, so much the better."

While reimportation does not include biologics, the Washington-based Biotechnology Industry Organization opposes the measure partially because it would be difficult to police what's coming over the borders...Pediatric Trials Legislation Hasn't Reached House Legislation requiring drug makers to run clinical trials on adult products that could be used off-label in the pediatric population made it through the Senate in July, but has yet to make it through to the House floor for a vote

The agency also cited the claim that "cognitive dysfunction is significantly correlated with brain atrophy," saying Biogen's clinical trials did not assess such a correlation...BIO Supports Oversight For Crop Biotechnology The Washington-based Biotechnology Industry Organization (BIO) adopted a voluntary moratorium to limit the geographic growing area where plant-made pharmaceuticals and industrial crops should be grown

Funding primarily is earmarked for Phase I or Phase II clinical trials in breast cancer therapeutics or chemoprevention...According to a statement released by the DOD, the goal is to establish partnerships between the biotechnology industry and academic institutions “that will reduce the drug development challenges faced by many biotechnology companies, and accelerate development of novel breast cancer therapeutics and chemopreventives...For more information, visit http://cdmrp.army.mil/ funding

EU Clinical Trials Rules Formalized The EU rules on clinical trials for new medicines have at last been formalized - some four months after the EU institutions agreed on the final details...The final version of the directive, which lays down good clinical practice rules for conducting clinical trials on human subjects, and provides for an early start to most clinical trials, still insists in its final form that: "Written authorization shall be required before commencing clinical trials involving

By David N. Leff Science Editor Editor’s note: Science Scan is a roundup of recently published biotechnology-relevant research...The journal paper concluded, “The clinical utility of this meningeal-paracrine approach is broadly applicable to other CNS...Biotechnology Industry Organization – released a statement from its vice president of food and agriculture that made the following points: • Declining Monarch butterfly populations have been a concern for decades