FDAnews Drug Daily Bulletin

Novartis’ chronic obstructive pulmonary disease (COPD) candidate bested placebo in improving lung function, symptom relief and quality of life in a Phase III trial, setting it up for a 2014 U.S. filing.

The European Medicines Agency (EMA) has published a question-and-answer guideline on marketing applications for biosimilars, providing advice on a number of presubmission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing.

An agency advisory panel voted 18–4 with one abstention in favor of approval for Arena’s weight-loss drug lorcaserin.

India’s government is facing stiff resistance from foreign and local pharmaceutical companies over its plan to severely limit prices for drugs.

Osiris Therapeutics said that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

A database to track the prescribing and dispensing of certain pharmaceuticals has passed the New Hampshire House in an effort to combat prescription drug abuse.

Large numbers of local pharmaceutical companies will launch generic versions of Viagra after the patent for the erectile dysfunction drug developed by pharmaceutical giant Pfizer expired on Thursday in Korea.

Allergan, which makes Botox, will build a nearly $12 million research and development facility in Bridgewater.

More than a third of the nation’s prescriptions are now delivered electronically, a new report indicates.