Archive for October, 2011

New Things are Happening at USP for Biologics

Published by Angie Drakulich on October 4, 2011 under Biotech, Industry conferences

Angie Drakulich PharmTech editorI’m here in Seattle at the USP Science and Standards Symposium, which is focusing on all things biologic and biotech. Representatives from a majority of the pharmacopeia’s expert panels are here, as are a few FDA officials, and industry members from around the world–some 30 countries are represented in fact. Various new approaches by USP are aiming to help industry better understand, develop, test, and manufacture biological products, including biosimilars. Read more »

What Patients Don’t Know Could Hurt Drugmakers

Published by Erik Greb on October 3, 2011 under Drug Delivery, Manufacturing, North America News, Regulation, Trends

Erik Greb PharmTech editor

A few weeks ago, Representative Michele Bachmann (R-MN) made waves by claiming that the vaccine for human papillomavirus could have dangerous side effects. She retreated from her remarks after the American Academy of Pediatrics said that they had no scientific validity. Makers of biopharmaceuticals might feel vindicated, but a recent poll emphasizes that Bachmann is not alone in her views. Read more »

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