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Oct. 23, 2012

Vol. 9 No. 208

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ANDA Filers Fret: Stability Testing Tweaks Will Delay Approvals

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. Read More

EMA Offers Guidance on Marketing Applications for Transdermal Patches

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. Read More

FDA Addresses Gender Differences in ICH QT Guidance Revision

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. Read More

Bayer Drug Succeeds in Phase III PAH Trial

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. Read More

Sanofi Pasteur Presents Phase III Data for Investigational Quadrivalent Influenza Vaccine

Sanofi Pasteur, the vaccines division of Sanofi, presented an overview of Phase II and Phase III clinical trials for its investigational quadrivalent influenza vaccine. Read More

Vivus Obesity Drug Fails to Win European Agency Backing

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. Read More

U.S. Agency Rejects Using Bonds to Develop Drugs for Bioterrorism Threats

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. Read More

Critically Ill Children Often Get Drugs Off-Label

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. Read More

Pfizer to Acquire NextWave Pharmaceuticals

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. Read More