Indian Panel Reviews Celsentri Clearances
Executive Summary
An Indian expert panel has sought data on ViiV Healthcare's HIV entry inhibitor maraviroc (Selzentry/Celsentri) - among the drugs cleared, some years ago, with a trial waiver in the country and recommended for re-examination by a Parliamentary committee.
You may also be interested in...
Indian regulator in cahoots with industry and has 'skewed' priorities, says parliament
In what's perhaps one of the most damning reports on industry and the regulatory mechanism in India in recent times, a parliamentary standing committee on health and family welfare has charged that more than 30 new drugs were approved in the country without undergoing clinical trials.
ViiV close to licensing out Celsentri in India; rules out compulsory licensing concerns
ViiV Healthcare, the new holder of rights to Celsentri (maraviroc), is in advanced discussions to potentially license out the HIV therapy in India, a move that could perhaps work in its favour against any potential compulsory licensing challenge.
India IPR Realities: Pharma, Legal Heads Discuss Winds Of Change, ‘Damocles Sword’
Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.