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Adding rigor to the adverse event reporting process
The widely accepted statistic is that only about 10% of all adverse events (AEs) are reported to FDA. In 2010, that 10% equaled about 750,000 reports, which was an almost 31% increase over 2009 and the biggest year-over-year increase (as a percentage) in the last decade. The estimates for 2011 aren't due for another couple of months (per FDA), but they're expected to continue the upward trend. Pharmacovigilance experts agree that one of the main drivers of recent growth in AE reporting rates is, quite simply, increased awareness . . .
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Generics Manufacturers Grapple With Tight Economics
But the global picture is sunny as most of the global market
growth benefits the generic makers . . .
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THE ONGOING DIABETES BATTLEGROUND
Even as diagnosed (and "prediabetes") cases rise worldwide, healthcare providers struggle with patients to control the course of the disease. New therapies--and new health services--are aiding in the battle . . .
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For a Lucky Few, Biopharma Expansion a Reality Again
Last April, Diplomat Specialty Pharmacy announced plans to centralize its operations in 340,000 square feet of space at the Great Lakes Technology Centre, the former innovation center for General Motors, in Flint, Mich. One rapid $7 million renovation later, the space has been transformed into a state-of-the-art headquarters and compounding and distribution facility . . .
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The Struggle to Get Anti-Infectives on a Faster Track to Commercialization
A looming crisis in drug-resistant anti-infectives is not being met with a commensurate industry effort. Governments and industry are trying to cope . . .
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Rare Diseases and Orphan Drugs Lift Pharma Innovation
As hundreds of candidate drugs receive official "orphan" status, the Orphan Drug Act gets re-examined. Meanwhile, these drugs are driving the growth of specialty pharmacy . . .
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PDMA 2010: The Power of Sharing
The PDMA Alliance is celebrating its 20th anniversary at this year's annual meeting, to be held in San Diego on Oct. 3-6. Here's what attendees can expect to learn and experience at the meeting.
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The Drive to Develop New Commercial Models
Industry's coming challenges will force dramatic change on how products are brought to market and businesses are sustained. Industry leaders have already started the process . . .
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Site Selection 2010: Development Authorities Recalibrate Their Pitch as Biopharma Growth Slowly Rebounds
Faced with fierce competition, dwindling budgets and intense pressure to create jobs, economic development authorities are reinventing their recruitment strategies to attract life sciences employers . . .
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Optimization of 2-8 Degrees Celsius Controlled-Temperature Small Parcels
Shipment of temperature-controlled clinical trial materials, medicinal products, vaccines, and medical devices containing pharmaceuticals require proper packaging to ensure controlling the temperature of the payload . . .
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