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: Approval Announcements
More on the Complete Response Letter Track Record and Stock Impact
Last week, I ran a chart on the track record of Complete Response Letters versus approvals from the FDA, demonstrating that the latter is losing in favor of the former. Since then, the balance of power has changed even further. … Continue reading
Posted in Approval Announcements, Business/Industry News
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Full Disclosure on Complete Response Letter by Targanta
Companies take various approaches to revealing the information that is contained in a Complete Response Letter from the FDA, but Targanta Therapeutics Corporation (NASDAQ: TARG) was very thorough in its press release this week. It is not uncommon for small … Continue reading
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Cephalon Receives FDA Approval for TREANDA to Treat Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma
Cephalon had an approval announcement today that is worth sharing, not only from the clinical point of view, but from a communications point of view. It is an example of a smart announcement and one that demonstrates the growing importance … Continue reading
Posted in Approval Announcements
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