Do off-label drug practices argue against FDA efficacy requirements? A critical analysis of physicians' argumentation for initial efficacy requirements.
I Introduction THE FOOD, DRUG AND COSMETICS ACT of 1938 with amendments in 1962 forbids new drugs from being sold unless they have passed FDA-approved tests for safety and efficacy in a specified use, called the "on-label" use. Physicians are allowed, however, to prescribe an...

Drug's efficacy for treating depression 'exciting'.
VIENNA -- Mecamylamine, an old, rarely prescribed, truly obscure antihypertensive agent, may be favorably reincarnated as an antidepressant with a completely novel mechanism of action--and vastly greater potential use. The drug displayed favorable safety and efficacy as augmentation therapy in a double-blind, placebo-controlled trial in patients with...

Thomson Reuters White Paper Explores the Role of Biomarkers in Clinical Trials and Drug Development.
PHILADELPHIA and LONDON, Jan. 12 /PRNewswire-FirstCall/ -- Thomson Reuters today announced that it has published a new white paper on the topic of biomarkers drawing on expert insight from academics and key players in the pharmaceuticals industry. Called "Biomarkers: An Indispensable Addition to the Drug Development Toolkit," it explores...

Cordex Pharma Submits to the FDA an Amended Special Protocol Assessment for ATPace.
LA JOLLA, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (BULLETIN BOARD: CDXP) announced today that it has submitted to the U.S. Food and Drug Administration (FDA) an amended Phase 3 protocol for ATPace to be reviewed as a Special Protocol Assessment (SPA). The amendment addresses written comments recently...

TECHNIQUE FOR CREATING RAT EMBRIONIC STEM CELLS PUBLISHED.
Stem Cell Sciences plc (AIM:STEM, ASX:STC) is pleased to announce that pioneering research describing a technique for creating authentic embryonic stem (ES) cells from rats has been published in the prestigious peer-reviewed journal, Cell (Ref. 1). This publication is believed to be the first in which germ-line transmission from...

AutoGenomics CYP 2C19 Test Used in Study to Personalize Clopidogrel (Plavix) Dosing in Patients.
CARLSBAD, Calif., Jan. 22 /PRNewswire/ -- AutoGenomics, a leader in providing automated molecular testing solutions announced today that its CYP450 2C19 assay was used in a study to demonstrate the value of genetic variants in dosing of the antiplatelet agent, Plavix. Plavix, commonly known as Clopidogrel, is...

Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV).
CAMBRIDGE, Mass., Jan. 12 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. , a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today announced that it has initiated a proof-of-concept study of IDX184, a liver-targeted nucleotide prodrug candidate for the...

Genomics collaboration.
Pharmacy benefit manager Medco Health Solutions and the Food and Drug Administration have partnered to study genetic testing and the impact of genetics prescription drug efficacy, according to Medco. The agreement extends to Aug. 31, 2010. Over the next 2 years, Medco will deliver a series of reports to...

Genomics collaboration.
Pharmacy benefit manager Medco Health Solutions and the FDA have partnered to study genetic testing and the impact of genetics prescription drug efficacy, according to Medco. The agreement extends to Aug. 31, 2010. Over the next 2 years, Medco will deliver a series of reports to the FDA that...

Personalizing protein-drug interactions.
Abstract: The development of new drugs today is a hugely expensive process, with estimated costs of up to $1 billion to take a drug through to market. However, despite this seemingly massive expenditure, statistics show that the great majority of prescription drugs on the market today are only effective...