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A new study indicates that a protein produced by HIV invades uninfected B cells and inhibits a mechanism that makes certain antibodies very good at targeting invading agents.

Experts say proposed label changes or black box warnings would not significantly decrease ADHD drug prescriptions. But they see potential market opportunities for new products and generics.

A Q&A with Geoffrey Jarvis, counsel for the plaintiffs, with a response from Pfizer.

The high court could fine-tune the definition of what is patentable in deciding LabCorp v. Metabolite. Legal experts weigh-in on the nuances of the case.

A University of Chicago professor explains his findings that serotonin induces gasping in oxygen-deprived infants. These results will probably not lead to Prozac prescriptions for babies, but they could be used to find a genetic marker for SIDS risk down the road.

Economists discuss a recent article in Health Affairs, which argues that market demands, not R&D costs, determine drug prices.

The recommendation shows traditional risk-benefit analysis is still working, experts say. But they also believe the Tysabri saga illustrates a trend towards increased use of advisory committees and requirements for drug mechanism data.

WHEN I WAS GROWING UP, my favorite book was Aesop's Fables. I especially loved the way every story had a moral at the end to tie everything together: Try before you trust; the hero is brave in deeds as well as words; birds of a feather flock together; might makes right; don't be the boy who cried wolf. Those one-line messages packed a punch then, and still stick with me.

THE OLD FORMULA IS TRIED AND TRUE: GET YOUR reps informed and excited at a launch meeting, and you'll have a positive impact on the success of the drug. But too many pharma meeting planners forget that sharp PowerPoint slides and fancy dinners no longer impress sophisticated sales reps. Reps want more than a fresh presentation. They seek a new experience. They want to be wowed.

NO ONE REALLY KNOWS WHAT A DOCTOR IS thinking most of the time, and those of us who are patients can be happy about that. We are comforted when physicians keep their counsel until they complete an examination.

IN OUR APRIL 2006 ISSUE, we will explore the results of a reader study—a" pulse check" as we think of it—on the topics of promotional programs, meeting spend, and compliance, cosponsored by Maritz Travel and Pharmaceutical Executive. The study asked industry leaders about their perceptions of their companies' physician meetings in terms of audience, format, and budget, as well as their views on compliance regulations.

When planning meetings, pharma companies need to work beyond what they think is satisfactory.

One legal expert noted that the industry may be divided into two sectors: companies that have CIAs and those that will.

Knowing what falls into fixed and variable expenses will make it easier to note what falls into high priority.

For years, educational institutions have enjoyed their own Internet domain: .edu. US governmental agencies have .gov, and non-profits have been able to set themselves apart from the crowd with .org in their e-mail and Web addresses. Thanks to changes made to the Internet's Domain Name System (DNS) in 2001, subject-specific vertical segments have been able to flee the .com world for newly established domains, such as .travel, .jobs, .museum, and .info.

The disease profiles pharma companies pursue should shape the business models that enable them to grow.

Understanding how drugs are bought and paid for has always been a bit complicated. People used to say that pharma had two customers-physicians and patients. Only one of them used the drug, and neither of them knew the price. My, how times have changed. Now the industry has so many customers, it needs to stop and get to know them all over again. And that's at a time when drugs worth tens of billions of dollars are going off patent. To map pharma's shifting landscape, Pharm Exec convened a group of top market researchers to discuss the issues shaping an evolving industry. Topics ranged far and wide, from the advent of Medicare Part D, to the new focus on adherence, the role of international markets, even the brave new world of marketing to seniors' children.

Given the high volume of rep interactions with healthcare professionals, companies must work toward achieving a fully integrated system that collects data from across the entire enterprise.

Before a pharmaceutical company dispatches a sales rep to a medical practice, the marketing department learns some basic facts about the physician: how many new prescriptions she's written, how many refills, and how much upside prescribing growth she might generate. What the rep usually doesn't know: who else-nurse practitioners and physician assistants-prescribes medications in the office, at a nearby clinic, or sometimes in a separate practice just down the hall.

The newspapers seem shocked to learn that scientific journals occasionally publish things that aren't true. Where have they been?

Companies don't have the budget, but are being forced to do more active surveillance.

March 2006 CE.

The high court’s decision on this licensing dispute could have far-reaching implications for patent negotiations, legal experts say.

FDA pushed back the expected approval of this would-be blockbuster by giving manufacturer Sanofi-Aventis one ?approvable? letter and one non-approval. Analysts say the drug?s success depends on approval for more indications, and delay could give advantage to a competitor in the smoking-cessation category.

An analysis of Merck’s clinical trial data for Singular (montelukast) indicates that obese people may respond to asthma treatments differently than lean people. A University of Michigan professor explains his recently published paper.

Domino Integrated Solutions

Thomson PharmaSM - Integration enhances communication

One percent of mothers taking SSRI’s during the second half of pregnancy gave birth to babies with pulmonary hypertension, a recent study found. But the mechanisms that connect increased serotonin with this disorder are unknown.

The door to growing vaccine proteins in plants is officially opened with a USDA-approved veterinary product. Is the FDA prepared for human vaccines grown in plants?

Generic drug advocates say flat funding for the Office of Generic Drugs in the 2007 FY budget will do nothing to decrease the growing backlog of products waiting for approval. They claim other streamlining techniques will not reverse this trend.