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Category Archives: Regulatory
Onyx Bullish in 2012 Outlook
With an all-important FDA decision on carfilzomib scheduled for July 27, Onyx hopes to graduate to the next stage of commercial success. For a feature-length profile of Onyx and CEO Tony Coles, click here.
Following on a strong 4Q report, Onyx Pharmaceuticals’ CEO Tony Coles said the company hopes to transform itself from a one-product [...]
Also posted in FDA, Market Access, People, R&D, Strategy, pricing Tagged carfilzomib, Earnings, forecast, Onyx Pharmaceuticals Leave a comment
Combating Opioid Abuse With Science
So far, the creative approaches industry has taken to develop tamper-resistant and abuse-deterrent opioid drugs have been largely matched by the ingenuity of those users who manage to tamper with and abuse those same formulations.
Also posted in FDA, R&D, Safety, Strategy, Technology Tagged drug safety, FDA, new molecular entities, opioids 3 Comments
2012: A Good, Bad, and Ugly Year for France's Servier
By Nathan Jessop.
Whichever way you look at it, 2012 will be a dramatic year for Servier. The French company has a number of collaborations that could lead to a new generation of products, but any positive news from these developments is likely to be overshadowed by the ongoing safety scandal of its diabetes treatment Mediator [...]
FDA: Steps Toward Quantitative Safety Assessment
A new collaboration will move FDA closer to predicting adverse events – before they happen – as part of the regulatory process
In an article published in Nature last June, FDA’s Darrell Abernethy, Lawrence Lesko and Janet Woodcock outlined the agency’s desire to incorporate “mechanism-based drug safety assessment and prediction” into the regulatory approval process. [...]
Also posted in FDA, R&D, Safety, Technology Leave a comment
GlaxoSmithKline Recalls Antihypertensive Drug Made at Novartis Facility