Gilead Sciences Inc., of Foster City, Calif., submitted a new drug application for adefovir dipivoxil - a once-daily, oral nucleotide reverse transcriptase inhibitor (RTI) - for treating HIV-infected patients whose disease is progressing despite prior RTI therapy. The product received fast-track designation from the FDA. Gilead expects to file for approval in Europe later this year. (See BioWorld Today, March 4, 1999, p. 1.)
Inhale Therapeutic Systems Inc., of San Carlos, Calif., said the first patients have begun dosing in a Phase III trial testing inhaled insulin, using the company's pulmonary delivery system. Partner Pfizer Inc., of New York, is managing the study, which will include Type I and II diabetics and more than 117 sites. (See BioWorld Today, Nov. 12, 1998, p. 1.)
Vysis Inc., of Downers Grove, Ill., entered into a cooperative research and development agreement with the National Human Genome Research Institute of the National Institutes of Health, in Bethesda, Md., and the Institute of Pathology at the University of Basel, Switzerland. The two-year deal calls for use of Vysis' GenoSensor and fluorescence in situ hybridization systems with the genome institute's tissue microarrays to define and study amplifications of specific genes in cancers. Vysis has an option to negotiate a license to the findings.