FDAnews Drug Daily Bulletin
Oct. 23, 2012 | Vol. 9 No. 208
The FDA’s plan to require more stability data for ANDAs is likely to slow approvals unless the agency flexes a little, generic-drug makers say.
Manufacturers of transdermal patches should minimize the amount of residual drug substance in the patch as much as possible to avoid patient and environmental safety risks, according to a new European Medicines Agency (EMA) draft guideline.
The FDA has revised and clarified a final ICH question-and-answer guidance on the evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
Bayer reported positive data from an ongoing Phase III Patent-1 study evaluating the oral guanylate cyclase (sGC) stimulator riociguat (BAY 63-2521) as a treatment for pulmonary arterial hypertension (PAH) in treatment-naïve patients and those who have previously received an endothelin receptor antagonist or prostanoid therapy.
Sanofi Pasteur, the vaccines division of Sanofi, presented an overview of Phase II and Phase III clinical trials for its investigational quadrivalent influenza vaccine.
Vivus’ obesity drug, approved in July in the U.S., failed to gain the backing of European drug regulators because of its potential side effects.
A U.S. Department of Health and Human Services office has rejected an industry proposal to use government bonds to fund the development of drugs countering bioterrorism threats.
The majority of drugs used in the pediatric intensive care unit are used in an off-label manner, exposing patients to medications that may not have been adequately studied in children, according to a single-center study.
Pfizer announced its intention to acquire NextWave Pharmaceuticals, a privately held, specialty pharmaceutical company focused on the development and commercialization of unique products for the treatment of attention deficit/hyperactivity disorder and related central nervous system disorders.
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