Tag Archives: Clinical trial

The Case for Specialty Medicines: Is Industry Credible, or Culpable?

What’s so special about specialty? This was the question lurking below the surface in many of the presentations at a conference hosted by Pharm Exec’s sister organization, CBI, in Philadelphia last week. Now that the blockbuster era is fading under a wave of patent expirations, big pharma is pinning its hopes on the specialty category […]
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A Lead Drug on the Way? All Eyes on FDA

For NeurogesX, a small biopharma company based in San Mateo, CA, time does not stand still. Every day preceding November 16 brings its flagship drug, Qutenza, one step closer to approval. Until then, the company has turned its energies to finalizing its US commercialization strategy. (NeurogesX previously entered into a commercialization agreement with Astellas Pharma […]
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Pharma Celebrates its Own

At the gala ceremony for the 2009 Prix Galien USA award on October 1, a paradigm shift in drug development took center stage. “The most successful new [cancer] therapies will be based on a precise molecular understanding of disease basis—that’s exactly what we did with Gleevec,” said keynote speaker Brian Druker, director of the Oregon […]
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Q&A with Steven Paul: Lilly’s New Development Plan

Last week, Lilly announced a major restructuring plan focused around the creation of one Developmental Center of Excellence and several individual business units. The media (Pharm Exec included) focused on the news that 5,500 jobs were being cut as part of the plan. This week, we’re talking to Lilly to find out what the company’s […]
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Feds Chase Down Faulty Skincare Promos

FDA’s Division of Drug Marketing Communications, this week, posted a slew of warning and untitled letters to pharma firms for misleading skincare advertisements. Johnson & Johnson, Galderma, and Allergan each received a letter documenting complaints ranging from false advertising to unsubstantial efficacy claims. J&J received a violation letter in response to a journal ad for […]
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