GVK Bio Expects To Complete Phase III Trials On Wyeth’s Prevnar 13 By Year’s End
This article was originally published in The Pink Sheet Daily
Executive Summary
Wyeth and GVK Biosciences were cleared in May to restart the Indian trials after no links were found between the alleged death of an infant in a Bangalore-based hospital and the trials.
You may also be interested in...
GVK Bio Says It Found No Link Between Wyeth Prevnar Vaccine And Child Death; Inspectors Did Not Check Documentation
MUMBAI - GVK Biosciences, the clinical research organization responsible for site monitoring for Wyeth's Prevnar vaccine trial in India has said it found no linkage between the administered vaccine and the death of a child, who died during the course of the clinical trials at Bangalore's St. John's Hospital's National Academy of Health Sciences
Indian Investors Turn Cautious On Compliance Concerns
A rising number of enforcement actions by major drug regulators like the U.S. FDA is slowly making investors cautious about the longer term repercussions on earnings of Indian drug makers.
Lee Takes India Compulsory License Fight To Saxagliptin
In a bold move, little known Indian drug firm Lee Pharma has applied for a compulsory license for saxagliptin in India, contending that AstraZeneca sells the diabetes drug at an exorbitant local price and that it is not being made sufficiently available. Lee also says that the originator has not responded to calls to collaborate.