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: September 2008
Bristol-Myers Squibb to Commence Cash Tender Offer for ImClone Systems at $62.00 per share
NEW YORK, September 22, 2008 – Bristol-Myers Squibb Company (NYSE: BMY) today announced that it is increasing its initial offer for ImClone Systems Incorporated (NASDAQ: IMCL) and intends to commence a tender offer for the currently outstanding shares of common … Continue reading
Posted in Business/Industry News
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Gilead Receives Complete Response Letter from FDA for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis
Since Complete Response Letters (CRLs) have become the fashion for CDER after August 11, I have tried to make it a point to see how different companies respond to the receipt of such a letter in public communications. As I … Continue reading
Posted in Complete Response Letters
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Weekly Roundup – 09/19/08
What a week. I’m super busy. Hence I’m’ not publishing the Weekly Roundup until Sunday. Sorry about that Weekly Roundup gauchos. And while lots and lots and lots happened this week, I was left with little or no time to … Continue reading
Posted in Weekly Roundup
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FDA Slams Ranbaxy
Sorry no posting the past few days. Super busy. There has been growing concern in the United States over the issue of importation, pertaining not only to the importation of prescription drugs for personal use, but that which has lately … Continue reading
Posted in Warning Letters
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Weekly Roundup – 09-12/08
Well, Congress is back. You may be relieved that your representation is back at the seat of government, doing that voodoo that they do so well. For me, it means a longer commute and more bad drivers on the road. … Continue reading
Posted in Podcast, Weekly Roundup
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