PHARMACY

A bright spot in faltering Rx market: specialty meds for serious conditions

BY Jim Frederick

NEW YORK Thank the booming development pipeline for specialized, highly targeted medicines for a modest rebound in U.S. drug approvals in 2008, according to new reports from the Bloomberg news service, the Food and Drug Administration and other sources.

Specialty and rare-disorder drugs fueled a weak but significant resurgence in the number of new drugs approved for marketing by the FDA last year, Bloomberg reported. Based on a running tally from the FDA and the news service, the agency cleared a total of 25 new drug entities for market in 2008, up from 19 the previous year.

By contrast, the FDA approved 36 new drug entities in 2004—and an average of 30 to 45 new drug approvals a year in the 1990s and earlier in this decade, according to IMS Health. That formerly robust approval rate may not be matched for some time to come, IMS vice president of industry relations Doug Long noted recently.

Specialized and bioengineered pharmaceuticals for serious conditions like cancer—and for relatively rare conditions—account for some of the new drugs entering the market. Those entries notwithstanding, IMS predicts the U.S. pharmaceutical market will remain relatively stagnant in 2009, with a growth rate of 1 to 2 percent. That marks a downward revision from the research firm’s earlier projections.

“In 2009, the expected 1 to 2 percent growth rate in the U.S. will result in sales of $292 [billion] to $302 billion,” IMS reported recently. The slowdown, the company reports, “reflects the impact of continuing patent expirations, fewer new product launches and a tighter economy.”

Indeed, added Murray Aitken, senior vice president at IMS, “The U.S. pharmaceutical market has entered a new era—one characterized by more modest growth due to the continuing impact of new generics products, fewer and more narrowly indicated novel medications, and closer scrutiny of safety issues. We will see additional lower-cost treatment options for many patients, while new and innovative therapies are delivered to specific patient groups, such as those suffering with cancer.”

According to a report from the journal Health Affairs, the rate of growth in U.S. healthcare spending has also fallen off dramatically. Health spending slowed to its lowest rate since 1998 in 2007, according to a Health Affairs analysis, with overall spending rising 6.1 percent in 2007 to $2.2 trillion, or $7,421 per person.

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PHARMACY

Researchers test administering medication using nanotechnology, gold

BY Alaric DeArment

NEW YORK Researchers have developed a way to use tiny particles of gold to control the administration of drugs for diseases such as cancer, according to a study published in the journal ACS Nano.

The researchers, at the Massachusetts Institute of Technology, created a device that shines infrared light on particles of gold coated with medicine.

The particles vary in size, causing them to melt at different rates depending on the intensity of the light.

The researchers said the device would allow medicine to target specific areas of the body at specific rates, thus minimizing damage to healthy tissue.

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N.J. tests new law requiring vaccinations for school-age children

BY Alaric DeArment

TRENTON, N.J. New Jersey will find out this week if its new law requiring flu vaccinations for schoolchildren has worked, according to published reports.

The state is the first in the country to require schoolchildren to receive flu vaccinations, between the ages of 6 months and 5 years. It required the children to receive the vaccinations by Dec. 31. Children who have not been vaccinated will not be allowed to attend school.

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