FDA convenes pediatric committee to discuss flu, asthma drugs
WASHINGTON The Food and Drug Administration will be conducting a meeting of its pediatric advisory committee to discuss the safety of a number of drugs, including the influenza medications Tamiflu and Relenza and the asthma drugs Serevent and Advair, according to online reports.
The asthma medications already carry a black-box warning about a risk of asthma-related deaths, but none of the side effects has been specified to children. While the FDA staff memo said the review was limited by the small number and incomplete nature of some potential side-effect reports, the staffers still “conclude that salmeterol, the active ingredient in Advair and Serevent, may have an unfavorable risk-benefit ratio in the treatment of pediatric asthma.”
FDA safety reviewers also suggested that both Tamiflu and Relenza should get label updates with information about neuropsychiatric events, such as hallucinations, reported occasionally among users; Tamiflu already has a label precaution about this potential side effect.
Roche, which manufactures Tamiflu, and GlaxoSmithKline, which makes Relenza as well as Advair and Serevent, both agree that the labeling on the drugs is fine the way it is, but are “open” to considering suggestions made by the FDA.
Gene Logic receives milestone payment from Pfizer for drug repositioning
GAITHERSBURG, Md. Gene Logic has reached a collaboration milestone, triggered by the filing of a patent application for a new use of an existing Pfizer drug candidate to treat solid tumors. Gene Logic’s Drug Repositioning Division discovered the new use for the unapproved drug candidate.
Under its drug repositioning agreement with Pfizer, Gene Logic has been seeking new therapeutic applications for selected drug candidates that are no longer in active development. The terms of the agreement provide for payment by Pfizer to Gene Logic of success-based milestones per compound and royalties on the commercialization of drugs whose repositioning results from Gene Logic’s Drug Repositioning Program. Gene Logic will receive a small initial milestone payment as a result of the filing of the patent application.
“We are pleased to see our Drug Repositioning Program yielding potentially valuable intellectual property for Pfizer. Our goal is to apply our drug repositioning capabilities to complement our partners’ internal pipeline development efforts,” Charles L. Dimmler, III, Gene Logic’s chief executive officer and president, said. “By finding new indications for de-prioritized, clinical stage drug candidates, our partners have another route to build value in their pipeline. We consider the filing of this patent application by Pfizer to be a substantive validation that our systematic approach to drug repositioning is working effectively.”
MedCenter system features monthly, not weekly pill boxes
CINCINNATI With more and more patients forgetting to take their medications daily, technology has been developed to help these patients remember to take their medications each day and on time. The newest product on the market is the MedCenter System, a reminder system that combines a monthly medication organizer with an alarm clock that verbally reminds users to take their pills.
Unlike most weekly pill boxes, the MedCenter system consists of 31 daily date-specific pill boxes with four compartments so that the users can organize pills by daily dose times. Each day, the user visually matches the day of the months’ box with the clock’s large LCD date. At each dosage time, the talking alarm clock will remind the user to take his medication.
Many national retailers are already stocking the new product, ($69.95), including Kroger pharmacies. In addition, it’s available online at www.medcentersytems.com or amazon.com. More product information is available online www.medcentersystems.com.
“As my parents begin to age and their medications increased in number, they needed reminders to make certain that they took them properly,” said the inventor Martin Cooper. “The MedCenter system gives my brothers and me peace of mind that Mom and Dad are taking their medication properly.”