With trial waivers India moots PMS norms for anticancers
This article was originally published in Scrip
Executive Summary
India's apex committee for regulating clinical trials has endorsed trial waivers for five products, including the anticancer enzalutamide ( Astellas/Medivation's Xtandi), the hepatitis C treatment sofosbuvir and MDR-TB drug bedaquiline, albeit with conditions attached in certain cases.
You may also be interested in...
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.
India IPR Wheels Are Turning: Novartis, Bayer, Sun, Legal Heads Discuss Realities
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.
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.