India's biotherapeutics leader Biocon Ltd is seeking approval from US FDA to conduct clinical trials for its oral insulin product code-named IN 105, reports said.
Artificial pancreas, a fully automated system to dispense insulin to patients based on real-time changes in blood sugar levels, is currently under development.
Indian regulatory officers will carry out random on-the-spot inspections on clinical trial sites to check deviations from July 2010.
Gardasil is currently approved for use in girls and women 9 to 26 years of age
Davunetide, an investigative drug for the treatment of Progressive Supranuclear Palsy (PSP), has been granted Orphan Drug Designation by the United States Food and Drug Administration (US FDA), Allon Therapeutics Inc announced.