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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.

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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.

Generics supplement, September 2006. List of proposed content.

All things considered, POS is undervalued and therefore underutilized, given its inherent potential to build recognition and increase demand.

In 2004, US growth hormone sales reached nearly $711 million. But harsh restrictions on growth hormone treatments and their abuse as "lifestyle drugs" have injected controversy into the market. How can pharma ensure that its marketing efforts for products that help millions of children and adults reach the right targets?

As 2006 gets under way, changes in the industry are creating new opportunites for product managers, along with a landslide of challenges. Blockbuster drugs that represent 50 to 60 percent of pharmaceutical sales will come off patent in the next few years, and with consumer awareness now greater than ever, product managers need to work even harder to keep up. The articles in this volume address these growing concerns.

The pharmaceutical industry imposes higher standards on advertising, PR, and medical education agencies than any other industry, except perhaps the financial services sector. Agencies need to keep up with constantly changing rules for advertising and promoting drugs or devices.

Accredited CME providers place a lot of value on understanding doctors' preferences and opinions. To better educate themselves, providers perform ongoing needs assessments to determine educational requirements, and actively survey clinicians for feedback on industry hot topics.

Imagine a person sitting alone in his living room suffering through a pounding migraine, while the rest of his family sits together around the kitchen table. He wants to join them, but his symptoms render him motionless. Now, imagine he has the choice to take two different drugs that promise to alleviate symptoms of his migraine. Drug A promises to help at the source of the problem by decreasing the frequency of swollen blood vessels around the brain, while drug B promises migraine-free days with more time to spend with the family. What do you think he would choose?

At the Division of Drug Marketing, Advertising, and Communications (DDMAC), our goal is to assure that prescription drug promotion is not false or misleading, and that it presents a balanced picture of a drug's risks, as well as its benefits.

Pharma companies spend the most money looking at what their competitors have already done. Here, three companies explain how competitive intelligence should work.

The good news is that America's top newspapers were fairer to pharma in 2006. But coverage remains largely negative-and the hot topics are catching the industry by suprise.

February 2006 CE.

An entertaining Internet program that allows Americans to see where a dollar goes after they spend it, helped scientists develop a formula for how infectious diseases spread geographically in United States.

Upcoming competition, a weak pipeline, and existing marketing agreements limit the pool of prospective buyers, experts say.

The class action settlement illustrates a trend toward increased transparency, lawyers say. But issues about timing clinical trial disclosures are still unresolved.

Observing drug candidates in humans early in the development process could save investigators time and money, experts say.

Q&A with supply chain expert Prashant Yadav, lead investigator on a study of how to improve flu vaccine distribution.

Learn how RFID technology works and what it could mean for pharmacies down the road.

BPA Statement

Two experts are split over the importance of research on a gene linked with a rare genetic type of Parkinson’s disease. One thinks it could hold the key to new treatment. The other thinks it is too rare to be relevant.