PharmExec Blog

The “Value” of Rx’s Under Obamacare

In the wake of last week’s declaration by new HHS Secretary, Sylvia Burwell, that “Obamacare is working”, it’s probably time for American Rx product managers and marketers to step back and consider where we have travelled since January 1st of this year. Here are a few key remembrances: Read More »

Posted in Strategy | 1 Comment

ePatient Connections: Highlights from This Year’s Summit

This month’s ePatient Connections Summit in Philadelphia, PA, saw biopharmaceutical firms, medical device companies, and patient advocates discuss best practices for engaging patients online and in social media settings. Two main themes arose from the conference: online patient engagement and patient centricity.

For the highlights of the event, read Moe Alsumidaie’s Applied Clinical Trials blog here.

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US Company Awarded UK's First "Promising Innovative Medicine" Designation

By Leela Barham.

The UK’s Medicines and Healthcare Regulatory Authority (MHRA) has awarded Northwest Biotherapeutics, Inc. (Bethesda, MD) the very first “Promising Innovative Medicine”, or PIM designation, for the company’s DCVax-L product. Read More »

Posted in Europe, Global, Guest Blog, Regulatory | Tagged , , , | Leave a comment

FDA’s New Emerging Technology Team to Assist “Innovative Manufacturers”

FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and “overcoming roadblocks”. Read More »

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Europe and Canada Welcome Trade Agreement Text

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Canada’s Research-Based Pharmaceutical Companies (Rx&D) have welcome finalization of the text for the Comprehensive Economic and Trade Agreement (CETA).

CETA represents the first free trade agreement between any G8 country. EFPIA and Rx&D believe it will, once in place, be beneficial to patients on both sides of the Atlantic, as well as for innovation and research.

Russell Williams, President, Rx&D: “CETA represents an important step towards putting Canada on the same playing field as its major trading partners… We now look to the governments involved to move swiftly on implementation; this is good for all the countries involved, and it’s good for Canadians.” Read More »

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