Pharmalot

May 16, 2012
FDA Reviews Drugs Quite Quickly, Thank You: A key point in the debate over renewing the Prescription Drug Fee User Act, or PDUFA, has been the ability of the FDA to review drugs as quickly as possible. Along with the pharmaceutical industry, various members of Congress complain the agency moves too slowly. But a new study in The New England Journal of [...]

May 16, 2012
Former Bristol Exec: ‘Call Me A Schlemiel’: Three years ago, a former Bristol-Myers Squibb senior vice president named Andrew Bodnar pleaded guilty to lying to federal authorities about a botched patent deal involving the Plavix blood thinner, an episode that contributed to an overhaul of its c-suite. As for Bodnar, a judge did something highly unusual that quickly became a wry joke [...]

May 16, 2012
The Op-Ed: Moore’s Law And Biosimilars: As the FDA continues to grapple with devising a final blueprint for developing biosimilars, big drugmakers and biotechs are jockeying for position. A decision, however, is not due for some time. Still, the law that allows biosimilars on the marketplace is two years old and the FDA has yet to receive an application. The implications, [...]

May 16, 2012
Trying To Close A Credibility Gap In Research: Two years ago, nearly two dozen medical journal editors and pharma execs convened a roundtable to grapple with growing controversy about the credibility of published research. Specifically, they were sorting out complaints concerning ghostwriting (see here), the extent to which researchers are given full access to clinical trial data and perceptions that industry-sponsored research can [...]

May 16, 2012
Pharmalot… Pharmalittle… Good Morning: Good morning, everyone, and how are you today? Tis the middle of the week and that means a cup or three of stimulation is in order. Please feel free to join us. This will be another busy day as we go out of our way to forage for documents and attempt to contact the uncontactable [...]

May 15, 2012
Should A Federal Agency Oversee The DSM?: Last week, the American Psychiatric Association unexpectedly backed down from two controversial proposals that would have increased the number of people who could have been diagnosed with psychotic or depressive disorders. The change meant that attenuated psychosis syndrome and mixed anxiety depressive disorder will not be listed in the fifth edition of the Diagnostic and [...]

May 15, 2012
How Payers View Pfizer’s Rheumatoid Arthritis Pill: An FDA panel may have recommended a new Pfizer pill for rheumatoid arthritis last week, but of course, the drugmaker must still win over regulators, doctors and payers. And while Wall Street is betting the FDA will approve tofacitinib, convincing payers of its worth may prove more difficult. Although pricing will be a major determinant [...]

May 15, 2012
Petition Demands Novartis Lower US Gleevec Price: As Novartis gears up for an important court case in India that can be traced to the pricing and accessibility of its Gleevec cancer med, the drugmaker is now facing a grassroots challenge in the US over the same issue. A petition was recently created on Change.org to demand that Novartis lower the price and [...]

May 15, 2012
Pharmalot… Pharmalittle… Good Morning: Hello, everyone, and how are you today? A spot of rain has descended on the Pharmalot corporate campus, where we have successfully hustled the short people off to their schoolhouses. And not a moment too soon, either, since we have another busy day filled with reading documents, phoning people and, hopefully, learning some interesting tidbits. [...]

May 14, 2012
FDA Issues New Advice For Novartis MS Pill: As their European counterparts did last month, the FDA has recommended continued use of the Gilenya multiple sclerosis pill sold by Novartis, but did say the drug should carry stronger warnings about heart risks and that some patients should undergo increased monitoring. The move was largely expected after the European Medicines Agency issued a similar [...]

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