It also had requested additional guidance on the types of preclinical or clinical data that could be considered as sufficient justification for the designation, with specific examples of diseases...Our sector has suffered too much from food scandals in the past to risk going against consumer opinion."

Such agreements are the life-blood of the biotech industry, since few biotech companies have the resources to undertake late-stage clinical trials and so are reliant on out-licensing to big pharma partners to see their products through to market," it said...The website also groups the individual voting patterns by nation, showing that members of parliament from Austria, Belgium, Denmark, Finland, France, Greece, Ireland, the Netherlands, Portugal, Sweden and Spain were largely in favor of tighter

The biotech medicines sector will be further affected by new rules on clinical trials and pediatric medicines...If the dam breaks, the logjam of products could turn into a flood," one senior European executive told BioWorld International.

He recognizes that the small biotech companies involved do not have the resources for large, long-term clinical trials to provide information on the cost-effectiveness of the treatment compared to conventional alternatives...One of the items on the agenda will be whether the EU should authorize BT11 corn - the latest challenger to the five-year-old informal EU moratorium on GM approvals.

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...The commission decided only to reconsider the matter at a further meeting on Jan. 28 - and it is still unclear whether the commission will be able to break the deadlock imposed by EU member states in 1999 on any new authorizations

It would require manufacturers to demonstrate that changes do not make new nonclinical or clinical studies necessary...The industry and other interested parties have until May to respond.

The European Federation of Pharmaceutical Industries and Associations has been lobbying Parliament over recent days to ensure that generic biotech products are required to undergo preclinical testing and clinical trials to demonstrate safety and efficacy...If that creates competition among member states for the most effective fostering framework, so much the better."

In particular, it has been discussing new information on insertional oncogenesis, based on the analysis of available nonclinical and clinical data following two serious adverse events reported in a gene therapy trial in France for the treatment of children affected by X-linked severe combined immunodeficiency...It concluded that testing of gonads for the presence or expression of vector sequence "does not give sufficient information as to whether the germline has been altered."

Highlights of the initiatives that are likely to have the most impact on firms developing biotechnology medicines in Europe include updates to the existing guidance on comparability of medicines containing biotechnology-derived proteins as drug substance (as well as contributing to meetings of the EU ad hoc group dealing with clinical and preclinical issues of comparability...In terms of gene therapy and cell therapy, the plans include further advice on the quality and the preclinical and clinical

The report suggests that increased funding is only a part of the solution, and that more pluralism in funding sources, lower dependence on closed national systems, and higher integration of research with teaching, clinical research and medical practice should become priorities of a European research policy for biotechnology...Submissions are being invited from organizations or groups of organizations from the 15 EU member states and the 13 EU candidate countries, but entities from other countries

once active leads identified, Immunex will elect whether to continue preclinical development with ArQule or to exclusively license leads to ArQule for clinical and commercial development (in exchange for milestones and royalties

s Agsome agrochemical delivery system (nanoencapsulation) to develop enhanced formulation of Roundup herbicide ND This agreement expands scope of the parties...initial focus is Roundup Ready alfalfa ND Letter of intent signed...development, evaluation and release of new NK brand alfalfa varieties with Roundup Ready trait ND ND (8/98) Gene Logic Inc

ImClone Systems Inc., of New York, disclosed the early achievement of a clinical development milestone under its agreement with Merck KgaA, of Darmstadt, Germany...Terms of the proposed offering were not disclosed.

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

BioWorld International Correspondent BRUSSELS, Belgium - The European Union rules on clinical trials for new medicines - with their additional constraints on biotechnology products - have at last been formalized, some four months after European Union ministers and parliamentarians agreed on the final details...The results of the conference will be presented to the G-8 Summit of Heads of State and Government in Genoa, Italy, in July to support their discussions on biotechnology, and will feed into

Ultimately, it said, potential risk must be evaluated against the intended clinical use of products...Frenchman Philippe Brunet remains as head of unit for the regulatory framework and market authorizations for pharmaceuticals, and Abraao Carvalho of Portugal has been made head of a new unit responsible for biotechnology and competitiveness in pharmaceuticals.

BioWorld International Correspondent BRUSSELS, Belgium - The European Union's new rules on clinical trials received their final approval, after more than a decade of discussion, from European ministers last week...This new directive aims to rationalize the documentation and administrative procedures for clinical trials on medicines, and at the same time to guarantee the same level of protection for patients across the EU...Until now, EU standards on good clinical practice were expressed only as

Roundup Ready alfalfa varieties for marketing by ABT