Monthly Archives: June 2011

Pfizer Asks Patients to Test Themselves

By Jennifer Ringler | Published: June 14, 2011
Can patients uphold the rigorous standards of clinical testing, outside of the clinic? Pfizer is betting that they can, at least for a drug that’s already spent a decade on the market. Last week, Pfizer announced its new Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) project—a clinical trial for already-approved overactive bladder medication [...]
Posted in Strategy | 2 Comments

Bad Ad: One Year of Fear

By Ben Comer | Published: June 13, 2011
FDA’s Bad Ad program, launched in May of 2010, resulted in some 328 reports of potentially untruthful or misleading promotion, a handful of Warning Letters, and several Untitled Letters. But the single most effective tool in the Bad Ad program’s toolkit, according to Arnie Friede, principal at Arnold I. Friede & Associates, and a former associate [...]
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CDER Addresses 'Challenges of Globalization' With a New Office

By Ben Comer | Published: June 8, 2011
In recognition of the difficulties presented by a rapidly expanding global drug market, FDA’s Center for Drug Evaluation and Research (CDER) has created a new office “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain,” according to memo sent by CDER director Janet Woodcock. The new “Office of Drug Security, Integrity [...]
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Creating Hope For Orphan Diseases

By Jennifer Ringler | Published: June 8, 2011
The Creating Hope Act of 2011, along with advancements in science and a shift in focus for Big Pharma, means that rare and pediatric orphan diseases may finally get the attention they deserve. “As a society, as we’re having this big debate around healthcare, everyone agrees that there’s a certain baseline of people that we [...]
Posted in FDA, Gene therapy, Regulatory, healthcare | Tagged , , , | 1 Comment

Mining Data to Gain a Competitive Edge

By William Looney | Published: June 7, 2011
When gauging influence in oncology prescribing, membership in the “club” still counts As the cancer therapeutics space grows more crowded, the task of identifying and building productive relationships with “key influencers” has become vital to a successful launch strategy.  Like everything else in oncology, performing that task is harder today. What was once an inbred club [...]
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