In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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...



Sun Loses Shine In Q1, Testing Times In US

Sun’s Q1 earnings were dented by provisions related to the generic pricing investigation settlement with the US Department of Justice of arm Taro, and the impact of pandemic-related lockdowns. Some clinic-administered products bore the brunt of lock-downs in parts of the US, though market share was unaffected.

Novartis India MD On Scalable Digital Solutions, Balancing Work-Life Mix Amid COVID-19

Novartis India chief outlines how the company is navigating the challenging business environment amid the coronavirus pandemic, including for its for-profit social business. Digital solutions are a key part of these efforts and the executive offers advice for those struggling to balance the work-life mix in these testing times.

Early API Momentum At Indian Firms: Not Just A Quarterly Bump?

Alembic and Biocon kick off the Q1 earnings season in India with significant growth in the active pharmaceutical ingredients business and expect to see continued momentum in the area. More Indian firms could gain as customers realign strategies and move away from single sources to de-risk their supply chain, learning from pandemic-related disruptions.

Topics

Related Companies

UsernamePublicRestriction

Register

ID1122434

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel