Pharmaceutical Executive-02-28-2006

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.