Bush Gives FDA Authority On Pediatric Trials President Bush signed legislation authorizing the FDA to force drug companies to conduct clinical trials of adult drugs used off-label in the pediatric population...Opponents to the legislation argue that it will add another layer to the drug-review process and has the potential to discourage off-label use of drugs.

Science Editor Editor's Note: Science Scan is a roundup of recently published, biotechnology-relevant research...From the clinical standpoint, a growing number of failures following the use of these agents has been described

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.

Science Editor Editor's Note: Science Scan is a roundup of recently published, biotechnology-relevant research...Exanta is the first oral anticoagulant to reach late-stage clinical trials since the development of warfarin 50 years ago

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."

Science Editor Editor's Note: Science Scan is a roundup of recently published, biotechnology-relevant research...A large-scale, long-term 70-center clinical trial of an experimental insomnia drug called eszopiclone is reported in the November issue of Sleep, a peer-reviewed publication of the Associated Professional Sleep Societies...The NDA contains a total of 324 clinical trials, which included more than 2,700 adult and elderly subjects, and more than 60 preclinical studies

Science Editor Editor's Note: Science Scan is a roundup of recently published biotechnology-relevant research...Although the main research finding showed no improvement in spasticity scores among patients given cannabinoids compared with placebo, the results suggest that cannabinoids could have potential clinical use for improving patients' mobility and pain control

Science Editor Editor's Note: Science Scan is a roundup of recently published biotechnology-relevant research...From a clinical point of view, it is possible that the changes in the skin are detectable before the other systemic manifestations

Sam Brownback (R-Kan.) and Dianne Feinstein (D-Calif.) wrote a letter to the Senate leadership encouraging them to consider the American Society of Clinical Oncology's (ASCO) proposal to fix the reimbursement system for cancer care in the pending Medicare bill, ASCO said...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

Science Editor Editor's Note: Science Scan is a roundup of recently published biotechnology-relevant research...Their report in The Lancet bears the title "Clinical importance of neutralizing antibodies against interferon beta in patients with relapsing-remitting multiple sclerosis...Our findings," the paper's lead author commented, "suggests that the presence of neutralizing antibodies against interferon beta reduces the clinical effect of the drug

Science Editor Editor's Note: Science Scan is a roundup of recently published biotechnology-relevant research...The report suggests that therapeutic drugs already in clinical trials for another disease may be effective for treating HIV-associated dementia...Such MMP2 inhibitors are already in clinical trials for cancer

The company is planning to use the funds for general corporate purposes and for clinical trials of PT-100, its lead product, which is being developed in a Phase I/II trial in combination with Rituxan (Genentech Inc.) in non-Hodgkin's lymphoma and chronic lymphocytic leukemia...If the companies elect to move ahead, they would share worldwide rights.

Its lead product, PI-88, is an anti-angiogenesis cancer drug that has shown promise in clinical trials, Progen said...Ltd.

Science Editor Editor's Note: Science Scan is a roundup of recently published biotechnology-relevant research...The actual use of EZH2 as a clinical test is still several years away, though the U-M team is planning a prospective clinical trial to test its use in breast cancer patients

Science Editor Editor's note: Science Scan is a roundup of recently published biotechnology-relevant research...Results From Clinical Trials Of Iressa EGFR Compound Reported In Journal Oncologist The Oncologist is a bimonthly international peer-reviewed journal for physicians devoted to cancer patient care...This article highlights the results of clinical trials that demonstrate the effectiveness and safety of gefitinib

Science Editor Editor's note: Science Scan is a roundup of recently published biotechnology-relevant research...In its August 2003 issue, the Journal of Clinical Endocrinology & Metabolism, just released online, highlights the need to maintain a healthy diet for infants and children, once breast feeding stops

The cancer therapeutics company said in its prospectus it plans to use net proceeds to fund clinical trials and other research and development expenses...are acting as co-managers.

Science Editor Editor's note: Science Scan is a roundup of recently published biotechnology-relevant research...The disorder and its dramatic clinical consequences, are preventable...The editorial calls "strongly for a randomized, controlled clinical trial of vitamin D analogues in the management of this disease to determine precisely whether one vitamin D analogue is superior to another

The co-authors did clinical and experimental studies to assess the role of this newly discovered coronavirus in SARS...Their paper began: "We tested clinical and postmortem samples from 436 SARS patients in six countries for infection with SARS-CoV...Laboratory investigations of clinical and postmortem samples, as already presented, fulfilled the first three criteria: (1) isolation of the virus from diseased hosts, (2) cultivation in diseased host cells, and (3) proof of filterability (to exclude