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: July 2008
What is Your Digital Literacy?
I’ve been writing a lot about the role of digital in pharmaceutical communications. If you don’t like that, you aren’t going to enjoy this posting. Sunday’s New York Times carried a highly interesting and large article called "Literacy Debate: Online, … Continue reading
Posted in Uncategorized
4 Comments
Eisai Gets Thumbs Down Action Letter
Another action from the FDA today that gives a thumbs down to an investigational drug. Today Eisai announced that it had received a non-approvable letter for the investigational compound fospropofol disodium injection which has been in review at the FDA … Continue reading
Posted in Uncategorized
5 Comments
A Not Approvable Letter That Outlines What is Necessary for Approval
This morning, Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced receipt of a not approvable letter from the FDA for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia. It is noteworthy on a few fronts. First, it … Continue reading
Posted in Approvable Letters
1 Comment
GSK Gets on Board with The YouTube Revolution –
In place of the Weekly Roundup this week, I am writing a regular post because of a new development I just saw on Twitter from my friend Brian Reid. So ok folks, first J&J got on board by creating their … Continue reading
Posted in New and Social Media
3 Comments
Genentech Forms Special Committee of Independent Directors to Review Roche Proposal
I’ve decided to add a new category for Business/Industry News. In these cases, the posting will be a re-print of press releases affecting the industry that I find of high interest. This one is from Genentech on the Roche offer. … Continue reading
Posted in Business/Industry News
Comments Off on Genentech Forms Special Committee of Independent Directors to Review Roche Proposal