About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Category Archives: Biologics
FDA Takes A Number of Actions to Enhance the Market for Biosimilars – A Process Not an Event
There is a policy interest in driving the biosimilar market. Among other reasons, increasing the number of generic drugs and biosimilars on the market addresses another policy priority – having an impact on the high cost of medicine. The approval … Continue reading
Posted in Biologics, FDA Policy
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Public Meeting on Biosimilars Scheduled for November – Questions Posed by FDA
The FDA has finally scheduled a public meeting to solicit input on the regulatory pathway that is being developed for the approval of biosimilars. The meeting is set for November 2-3 and will be held at FDA's facility in Silver … Continue reading
Posted in Biologics
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Insight into FDA’s Thinking on a Biosimilar Regulatory Pathway?
Today Teva Pharmaceuticals announced the receipt of a Complete Response Letter from the FDA for their Biological Licence Application (BLA) for Neutroval. Neutroval is a treatment to reduce the duration of severe neutropenia and the incidence of febrile neutropenia in … Continue reading
Posted in Biologics
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With a Untitled Letter, Does FDA Set New Policy on Stem Cell Use in the United States?
Here is a newsbreaker I think. Stem cells hold a great deal of promise in research and clinical trials are underway around the world to make that promise a reality. However, many entrepreneurial efforts have been underway to use stem … Continue reading
Posted in Biologics
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Turning Down the Pipeline on Biotechnology
On the Ides of March, Genetic Engineering and Biotechnology News (GEN) published an article by Ronald A. Rader, President of the Biotechnology Information Institute that provided an overview of the product approval rate focusing solely on biologics. For a long … Continue reading
Posted in Biologics
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