Archive for September, 2008

When will the U.S. develop concise generic biologic rules?

A lot of people have been asking my opinion on when a concise generic biologic regulatory pathway will emerge in the United States, and I give them all the same answer: Later. In my opinion complex regulatory schemes are not areas in which the United States can effectively lead. Why not? Because the size of […]

Commercializing biotechnology in China

I recently had the opportunity to conduct a brief interview with Mireille Gingras, Ph.D. President and CEO of HUYA Bioscience on doing business with and in China: Tell me about HUYA and what makes the company unique? HUYA Bioscience International has pioneered the most innovative and productive approach for pharmaceutical co-development between the U.S. and […]

Drug Patent Expirations in September 2008

Courtesy of Drug Patent Expirations in September 2008 *Drugs may be covered by multiple patents Tradename Applicant Generic Name Patent Number Patent Expiration ANDRODERM Watson Labs testosterone 4,855,294 Sep 6, 2008 AVITA Mylan Bertek tretinoin 5,045,317 Sep 3, 2008 DDAVP Sanofi Aventis Us desmopressin acetate 5,047,398 Sep 10, 2008 OPANA ER Endo Pharms oxymorphone […]