regulation

Jim Greenwood on Data Exclusivity and Healthcare Innovation

August 13, 2009

Biotechnology Industry Organization CEO Jim Greenwood appeared on CNBC’s SquawkBox defending the case for data exclusivity protection for novel biologic drugs. The video appears below. Interestingly, he used the Aspirin vs. Epogen comparison from my book, Building Biotechnology, when he was explaining the difference between small molecule and biologic drugs to members of congress. Share [...]

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An Overview of the Biopharmaceutical Landscape Ahead

April 16, 2009

John Avellanet, a frequent contributor to this blog, is giving a talk for my biotechnology management class at the NIH next week. He’s posted his slides and some background readings on his web site at http://www.ceruleanllc.com/NIH/. These materials will only be available until April 25th, so hurry on over and read them.

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Solving the FDA Crisis

February 5, 2009

Guest content from John Avellanet, managing director and principal of Cerulean Associates: Solving the FDA Crisis By John Avellanet, Managing Director and Principal of Cerulean Associates LLC News of the latest crisis under the FDA’s watch – salmonella contamination and the peanut plant in Georgia – has all the usual suspects calling for increased inspections [...]

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Introducing Biotech-U: Web-based courses on biotechnology

January 14, 2009

After months of effort, I’m pleased to announce the launch of Biotech-U, a biotechnology education resource featuring web-based lessons on biotechnology business, law, IP, politics, regulations, and science. Biotech-U is based on Building Biotechnology, the leading text used in business-of-biotechnology courses. The online-learning structure is designed to meet the needs of busy professionals who seek [...]

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

September 22, 2008

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 [...]

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An appeal for generic biologic legislation

February 10, 2008

The following appeal for generic biologic legislation was sent in from Insmed via youtube. I’ve posted previously on the challenges of developing a framework for generic biologic approvals and questioned how much we can really expect to save. In the editorial for the upcoming issue of the Journal of Commercial Biotechnology, I argue that the [...]

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Drug approvals fall. Who’s to blame?

August 16, 2007

The FDA approved 38 drugs through July this year, down 31 percent from 55 approvals for the same period last year. Who’s to blame? According to Friedman, Billings, Ramsey, the FDA. Why? Vioxx. For details on extra scrutiny being applied by the FDA, see this CNNMoney summary.

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