Category Archives: Strategy

CytRx Faces Partial Clinical Hold after Death in Compassionate Use Program

CytRx announced on Tuesday that FDA gave notice of a partial clinical hold for trials for its oncology candidate aldoxorubicin. The hold results from a reported death of a late-stage cancer patient “who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but had received aldoxorubicin under the Company’s expanded access […]
Also posted in FDA, Safety | Tagged , | Leave a comment

How Gilead “Blew Out the Lights” With Sovaldi

While flipping through my emails recently, I froze before an image that appeared on my screen. An old Rx colleague had sent me a graph, mapping out the 2014 U.S. sales achieved by Gilead’s Hep C drug, Sovaldi. It was stunning. Take a look:
Also posted in Marketing, pricing | Tagged , , | 2 Comments

Pharma Showing Signs of Stability Despite Patent Cliffs

The pharmaceutical market is beginning to show signs of stability, with a review of 30 leading companies highlighting combined revenues of $718.7 billion in 2013, down just 0.2% from 2012, according to GlobalData.
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Merck CEO Outlines Next Two Years as IFPMA President, Raises Ire on IP

Merck KGaA CEO Stefan Oschmann spoke last week in New York as he accepted the two-year role as president of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the R&D industry’s global trade group based in Geneva.
Also posted in Global, leadership | Tagged , , , , , , , | Leave a comment

We Need to Rock the Boat to Make Research Soar

By Wayne Kubick, Applied Clinical Trials. We hear it all the time these days: research processes have to undergo transformative changes in order for research organizations to thrive—or even survive. Controlled clinical trials take too long and cost too much. Regulatory review is blocking innovation. Research data must be shared transparently, drug manufacturers need to […]
Also posted in Guest Blog, Op-Ed, R&D | Tagged , | Leave a comment
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