Pink Sheet 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

Roche’s Immuno-Oncology Therapy On Course To Indian Debut?

Executive Summary

Roche’s cancer immunotherapy Tecentriq has received conditional marketing authorization under India’s layered approval process, setting the stage for a potential debut in the country. However, it remains to be seen how India’s evolving regulations in the area of clinical trial waivers could play out for such products.

You may also be interested in...



Roche India Mandate 'Completely Different' Says New Head Bezzera

Lara Bezerra, Roche’s new managing director in India, outlines in an interview with Scrip how the Swiss multinational is now looking at the Indian market through a different lens and beyond short-term gains.

India’s Trial Approval Timelines Report Card – Some Red Lines?

India’s streamlined clinical trial approvals process appears to have made some gains, but top industry experts tell Pink Sheet how the non-standardized approach of Subject Expert Committees is a “major handicap” for applicants.

BMS' Opdivo Heading Towards Indian Debut?

Bristol-Myers Squibb's PD-1 immune checkpoint inhibitor Opdivo (nivolumab) appears to be on course to a potential Indian debut, after a key local expert panel recommended the product for marketing.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1126093

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