HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Tesaro's Varubi Wins FDA Approval; Shares Up

This article was originally published in Scrip

Executive Summary

Shares of Tesaro jumped about 10% on Sept. 2 on the news the FDA had approved the Waltham, MA firm's new drug application to market Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (CINV) in adults.

You may also be interested in...



US FDA’s First Complete Response Letter Of 2017 Involves … Manufacturing

Tesaro’s IV formulation of Varubi draws letter keeping with last year’s emerging trend of manufacturing-related CRLs, in this case agency concerns about CMC data related to comparability of drug produced by two different contractors; issue seems unlikely to significantly delay approval of the new version of CINV drug, however.

Moderna's Valera Takes mRNA Approach To Combat Zika

With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.

Allergan's Price Reform Pledge: Will Others Follow?

Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

SC029668

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