Speedy drug-review process 'broken'

... Speedy drug-review process 'broken' - The Boston Globe - Boston.com - Business .padAll5, .padAll7, .padAll10, .padLeft5, .indent10, .fodorsIndent, .lighterIndent { height: 100%; } Personal Tech Markets Your Money Technology Columnists Latest news Message Boards Home > Business Speedy drug-review process 'broken' Markey seeks fines for firms that don't complete studies By Diedtra Henderson, Globe Staff | June 1, 2005 WASHINGTON - Almost 13 years after the Food and Drug Administration made it easier for companies to speed life-saving medicines to patients, US Representative Edward J.

Markey says the system of accelerated drug review is ''broken" and fails to protect patients.

ADVERTISEMENT Markey, Democrat of Malden, said he came to that conclusion after reviewing documents he requested from the FDA and the Securities and Exchange Commission detailing whether drug companies conducted required clinical trials and reported that information to shareholders.

Since 1992, companies pledged to complete 91 clinical trials in exchange for the FDA's speediest drug review.

Some 42 of the promised studies remain unfinished, including...

New drug targets brain tumors

... myDNA.com - News: New drug targets brain tumors -> myDNA.com Search Yellow Pages News Diets Search For In Entire Site Articles News Images AdvancedSearch Home » Resources » News Center » News: New drug targets brain tumors Page Tools Print This Page E-Mail This Page Add to Favorites Genetics Genetics Envirogenomics Nutrigenomics Pharmacogenomics Health Allergy Asthma Brain Tumors Breast Cancer Cervical Cancer Colorectal Cancer Diabetes Digestive Disorders Heart Disease Influenza Kidney Disorders Lung Cancer Mental Health Osteoporosis Ovarian Cancer Prostate Cancer Sexual Health Skin Disorders Weight Other Diseases Resources News Center 200505 Clinical Trials Diagnostic Tests Diet Center Discounts Feature Articles Find a Professional Medications Shopping Web Directory Tools News Center New drug targets brain tumors To learn more visit myDNA's Brain Tumors Center Read More Preliminary results from a Phase II clinical trial show patients with recurrent glioblastoma multiforme, a form of primary brain cancer, experienced a significant tumor response rate with minimal side effects when treated with enzastaurin, an oral, targeted agent under development at Eli Lilly and Company (LLY).(1) Enzastaurin is the first targeted agent of Lilly Oncology to enter into late stage clinical developm...

Lilly Targeted Agent Shows Promise in Treating Primary Brain ...

... Lilly Targeted Agent Shows Promise in Treating Primary Brain Cancer Lilly Targeted Agent Shows Promise in Treating Primary Brain Cancer Investigational Oral, Targeted Agent Shrinks Tumor with Minimal Side Effects in Glioblastoma INDIANAPOLIS, May 17 /PRNewswire-FirstCall/ - Preliminary results from a Phase II clinical trial show patients with recurrent glioblastoma multiforme, a form of primary brain cancer, experienced a significant tumor response rate with minimal side effects when treated with enzastaurin, an oral, targeted agent under development at Eli Lilly and Company (LLY).(1) Enzastaurin is the first targeted agent of Lilly Oncology to enter into late stage clinical development heralding a new phase of innovation for the group, which has produced Gemzar(R) (gemcitabine HCl) and "Recurring glioblastoma is a desperate disease for which there are very few adequate treatments," said Howard Fine, M.D., chief of Neuro-Oncology at the National Cancer Institute and lead author of the study, which was presented today at the annual meeting of the American Society of Clinical Oncology (ASCO).

Glioblastoma, a type of brain cancer, is part of the larger group of tumors that impact the central nervous system, known as gliomas.

Patients with highly recurrent glioblastoma are usually at a more advanced stage of the disease and correspondingly may face altered brain function or death...

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