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
Immunogenicity and Follow-on-Biologics
This week, the FDA issued a non-approvable letter to Momenta Pharmaceuticals as outlined in a press release from the company. The approvable letter was issued to Momenta and its partner, Sandoz, Inc, which is a generics manufacturing division of Novartis. … Continue reading
Posted in Biologics
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U.S. Stem Cell Policy – Ceding the Competitive Edge
By a margin of 63-34, the Senate passed the Stem Cell Research Enhancement Act – just 3 votes shy of a veto-proof bill. A veto is promised. We are back where we started. Opponents claim a moral high ground that … Continue reading
Posted in Biologics, Current Affairs, Legislation
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The Bio Conference and the FDA Survey
The BIO conference was held last week in the wonderful city of Chicago. A lot of people have been writing about it. So I decided to join in. The blog On Pharma has some very nice daily updates. Former President … Continue reading
Posted in Biologics, FDA Policy
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