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May 9, 2008

Litigation Into Perpetuity?

Drug Safety: A Lawyer’s View

A lawyer says litigation illuminates how the pharmaceutical industry thinks and conducts itself. A few forward-looking statements.

Trasylol, Bayer & Three Mile Island

Drug Safety Story Time

Reflections on the power of narrative and the industry’s wobbly reputation.

Less Dictionary-Based Pain

Updated Phase Coding Tool

Updating Central Coding for InForm, Phase Forward tries to simplify the management of vital dictionaries like WHO Drug and MedDRA.

Fringe Movements

Ode To Abigail

With the Supreme Court putting a long-simmering case to rest, we take a look at the lessons of the Abigail Alliance.

The V-Word

Merck’s Win, Industry’s Loss

The first class action settlement for Vioxx is good news for Merck but will play out differently for industry.

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IND Ethics Loophole

Circare: Academic Patient Advocate

April 21, 2008

Every other day, Adil Shamoo says he gets an inquiry about something untoward in a clinical trial. Shamoo, whose day job is professor of molecular biology, epidemiology and preventive medicine at the University of Maryland’s School of Medicine, is also the founder of Citizens for Responsible Care and Research (CIRCARE).… more...

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Shark Repellent

Empirica From Phase Forward

April 15, 2008

The clinical trial technology landscape is consolidating, with firms buying each other or limping along. In that context, last month’s rebranding of the safety software of Phase Forward is interesting. To quote the press release: “Phase Forward is unifying its safety products under a new product family name—Empirica—for its suite… more...

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A-List Of Speakers At Harvard

Post-Approval? Or Pre-Apocalypse?

April 08, 2008

Maybe it’s the medical school ambiance. Or the end of a long Boston winter. But every year, for mysterious reasons, the Post Approval Summit feels a bit different than other meetings. It’s a little cozier. More intimate. The conference is held in the spring in an auditorium at Harvard Medical… more...

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Strategies from Wyeth, Actelion & Pfizer

CTC 2008: Proactive Risk Abatement

March 10, 2008

Talk about a rock and a hard place. Once drugs reach the market, or as a condition prior to approval, the industry’s handling of risk is caught between the needs of regulators, shareholders and public. At the 2008 Clinical Trials Congress, held in Orlando, there were signs that the burdens… more...

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Litigation Into Perpetuity?

Drug Safety: A Lawyer’s View

March 05, 2008

When will the drug safety wars end? How will they end? A new president? A Supreme Court decision? We thought Tom Lamb might know. He’s an attorney based in Wilmington, North Carolina. Like it or not, lawyers like Lamb are shaping the perceptions of the pharmaceutical industry and clinical trials.… more...

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Trasylol, Bayer & Three Mile Island

Drug Safety Story Time

February 22, 2008

With the Oscars upon us, it’s time to reflect on something simple. Our brains store information and make sense of the world in stories. This is true in all cultures, all individuals. “She saved my career.” “They worked it out.” Homo sapiens specialize in stories. Stories are a more basic… more...

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Less Dictionary-Based Pain

Updated Phase Coding Tool

February 05, 2008

There has never been a time in the pharmaceutical industry when the coding of adverse events was more pivotal. The industry is not quite to the point of knowing that three identical events will trigger a product withdrawal. But it’s close. In that context, Phase Forward last week updated its… more...

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