March 18, 2014
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The future of clinical trials in an outsourced model
Life Science Leader
Rob Wright writes: "Another common future prediction tool, and one employed by Life Science Leader magazine for this roundtable, is that of expert opinion. I posed 10 questions to three clinical research experts to get a sense for the future of clinical trials in an outsourced model. The experts included Christopher Gallen, M.D., Ph.D., CEO SK Biopharmaceuticals; Mary Rose Keller, former VP of clinical operations, Sangart; and John Orloff, M.D., former SVP and chief medical officer, Novartis."
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Pharma's 4 options for innovation
It is now widely accepted that the pharmaceutical industry faces a near perfect storm as the old blockbuster model fails to renew fast-emptying drug portfolios and entire business models face obsolescence. Leaders agree profound change is required, but the direction of that change is far from obvious.
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Drug shortages vex the US despite the FDA's best efforts
The number of new drug shortages in the U.S. has fallen dramatically during the last few years. This comes after the FDA laid out a new strategy, and was helped by a presidential order that drugmakers must speak up if they foresee anything that even looks like it could turn into a shortage. Still, the total number of shortages keeps growing, leaving doctors to figure out how to change treatment plans when medications are unavailable.
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Baxter scrambles to retrieve glucose bags after reports of patient reactions
When Baxter International issued a four-country recall in December of some intravenous products contaminated with particulate matter, it said there had been no reports of adverse events. Same thing in January when it voluntarily recalled three lots of parenteral nutrition products in the U.S. But Baxter couldn't make that claim when the company recalled a single lot of a dialysis product in which mold was found. The drugmaker acknowledged that this time, there have been reports of reactions after patients received the solution.
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