Gene therapy and cell therapy are to see new regulations, with guidance on quality, preclinical and clinical aspects of gene transfer medicines using lentiviral vectors and on assays for neutralizing antibodies...The agency will issue new guidance on potency testing for cell-based immunotherapy medicines, on production and control of biotechnological and biological medicines, on the quality aspects of similar products in which the active substances are biotechnology-derived proteins, on clinical

raised C$21.7 million (US$17.6 million) to fund clinical trials for two lead compounds developed using its long-acting delivery platform...Net proceeds "will primarily go toward our ongoing clinical development programs," said Jacques Lapointe, ConjuChem president and CEO...Proceeds will be used to fund ongoing clinical trials of its candidate for Alzheimer's disease, and to develop its pipeline at the company's recently opened laboratory in Research Triangle Park, N.C. Voyager's Invention Center is

The seminar will examine topics such as the chemistry, manufacturing and controls, pharmacology/toxicology, clinical pharmacology and clinical aspects for assessment of the quality, safety and efficacy of follow-on protein products...The new guidelines allow authors to designate a time frame for public release - ranging from immediate access after final publication to a 12-month delay - when they submit their manuscripts to the NIH.

Net proceeds are expected to fund clinical trials of Telcyta, a cell-activated chemotherapeutic, and Telintra, a small molecule designed to treat myelodysplastic syndrome...and Harris Nesbitt. (See BioWorld Today, Feb. 9, 2005.)

FivePrime said its protein discovery system, ProScreen Engine, reached its optimal speed last year, completing a set of human secreted proteins in three new clinical indications every four months...Human clinical evaluations of a CDT-based immediate-release Raloxifene formulation are set to begin next quarter...Arena told BioWorld Today last week that proceeds will be used to advance its preclinical and clinical programs, and cover costs of developing new product candidates

In it, the agency had requested additional clinical data to identify a patient population and method of use for Symlin in which there is no increased risk of significant hypoglycemia or where there is an added benefit that clearly counterbalances any potential for increases in episodes of hypoglycemia...On Friday, Martek's stock (NASDAQ:MATK) gained $1.55 to close at $51.44.

The draft guideline urged a case-by-case approach for the nonclinical/clinical data package, dependent on the state of the art of analytical procedures, the manufacturing processes employed, and clinical and regulatory experience...It has been created to standardize the approach to early clinical use of valuable medicines in development

Its current portfolio includes three in-licensed compounds, with two of them already in clinical-stage development...Its natural properties allow for large-scale manufacturing for clinical trials, and its initial safety and toxicity profiles have proved promising...and several private investors.

Targacept intends to use the proceeds from its financing, which was led by London-based Nomura Phase4 Ventures, for the clinical development of its lead product candidates...The 73-person company has one marketed product, Inversine, and four candidates in clinical development, as well as several others at the preclinical stage...London-based Mulier Capital acted as placement agent for the financing, which provides the company with additional resources for its Advexin registration program, as well as

Four of those have advanced into clinical trials, including telavancin...They now have eight candidates, five of which are in clinical trials...The company has three products in clinical trials, and is conducting eight Phase II trials and one Phase III registration trial

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."

P&G will assume responsibility for preclinical and clinical development of lead Nanobodies, as well as the commercialization of any resulting products...And the third study showed reproducible, quantitative changes in the concentration of clinical CSF A-beta peptide variants in response to treatment with non-steroidal, anti-inflammatory drug compounds...Monsanto's NK603 corn, which is designed to be tolerant to the active ingredient in Roundup agricultural herbicides, is marketed as Roundup Ready Corn

and Affymax Inc. - plan to push their lead drug candidates through clinical development...One is move those two products that we have in Phase II development through the rest of clinical development, and two, it will enable us to get some of our preclinical products into the clinic...At some point we will look to partner Hematide as soon as we have sufficient clinical data and realize the value of it," Morris said

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

Website For Gene Therapy The FDA and the NIH have launched a web-accessible database on human gene transfer, called the Genetic Modification Clinical Research Information System (GeMCRIS...The site is located at www.gemcris.od.nih.gov.

Science Editor Editor's Note: Science Scan is a roundup of recently published biotechnology-relevant research...A pilot phase 2 clinical trial...The clinical study, led by researchers from the University of Melbourne in Australia, finds that treatment with an antibiotic that also removes zinc and copper from tissue might benefit patients with Alzheimer's disease (AD

The $30 million raised by CombinatoRx not only will go toward its clinical compounds, but also its preclinical candidates, said Robert Forrester, chief financial officer of the company...The company's three clinical products are CRx026, which is in Phase I/II work for multiple tumors, and CRx119 and CRx139, both of which are in Phase I trials for rheumatoid arthritis...CombinatoRx initiated clinical trials of all three lead compounds within the last six months and its "whole product engine has been

In addition to funding clinical trials of Celacade, the company plans to cover regulatory expenses for the drug...We plan to have this drug in clinical development at the end of the year," Elsley said...The company plans to use the proceeds to fund continued clinical development of G17DT, as well as to cover preclinical and clinical studies for other product candidates, including monoclonal antibodies

Science Editor Editor's Note: Science Scan is a roundup of recently published biotechnology-relevant research...The findings are published in the January 2004 issue of The Journal of Clinical Endocrinlogy and Metabolism