December 8, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
GVK Biosciences, a contract research organization, announced today that it is ready to re-do all of its clinical studies over drugs that the European Medicines Agency has marked red flagged. The EMA did so after reviewing the findings of French drug regulatory agency ANSM.
Four European countries, including France, had suspended the marketing authorization of 25 generic drugs. They had been approved based on bio-equivalence studies conducted at the GVK Biosciences facility. Although the findings by ANSM were related to the alleged manipulation of certain portions of ECG reports, GVK Biosciences says that it is still willing to take on the responsibility of redoing the tests for clients’ sake.
Branding for Clinical Development
In July, GVK Biosciences announced that it had created a new brand titled CLINOGENT for its work in the clinical development services industry. CLINOGENT will bring expertise in delivering solutions to complex data analysis and communication issue to the customer.
“CLINOGENT will be a unique clinical development service provider from India, as it will be able to address the clinical needs of both innovator biopharmaceutical and generics companies worldwide,” said Manni Kantipudi, CEO of GVK Biosciences. “I am confident this step will bring greater focus on delivering innovative and intelligent solutions and will make significant contributions in the clinical development value chain of our customers.”
The brand will reflect the company’s continued focus on strengthening its operational expertise and talent to offer comprehensive service in the clinical research and development realm.
The clinical development industry is worth approximately $16 billion, and it is set to grow at a rate of approximately 10.5 percent until 2020. Mergers and acquisitions have indicated a growing need for more clinical development solutions.
An Overview of GVK
GVK Biosciences considers itself to be one of the leading discovery research and development organizations in Asia. It provides services ranging from manufacturing to clinical development.
Its scientific pool includes more than 1,800 scientists, making it a leading life sciences company in India. It has five different locations across the country and a lab space that consists of 500,000 square feet.
In January, the company acquired Aragen Bioscience, Inc., which specializes in high value biologics services. As a result, GVK Biosciences as able to position itself as a leader of research and development services.
