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.
Monthly Archives: August 2008
Genentech Committee Responds to Roche Purchase Proposal
Genentech’s special committee formed to help the Board of Directors pose a response to the Roche purchase proposal has stated that they feel the offer "substantially undervalues" the company, but left open the door for a new bid. Here is … Continue reading
Posted in Business/Industry News
1 Comment
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
4 Comments
Cardiome and Astellas Announce Receipt of FDA Approvable Letter for KYNAPID
Today is supposed to mark the day that the FDA quits submitting approvable letters and starts issuing "complete response letters" – but it looks like one flew off the shelf just in the nick of time – at least per … Continue reading
Posted in Approvable Letters
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Warning Letter Summary – Second Quarter 2008
Warning letters from the FDA’s DDMAC have only been at the pace of a trickle under the Bush Administration, and the second quarter was no exception, though there was at least one interesting lesson to be learned. In April, DDMAC … Continue reading
Posted in Warning Letters
1 Comment
Weekly Roundup – 08/08/08
It is Triple 8 today. It is Friday. Congress is gone. The humidity has fallen and the high tomorrow is only supposed to be 80. (Congress leaves, so does hot air). There is every reason to feel right with the … Continue reading
Posted in Weekly Roundup
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