Scrip 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


Fast AZ Tagrisso Approval Springboard For Clovis?

This article was originally published in Scrip

Executive Summary

Prescription Drug User Fee Act (PDUFA) action dates have become meaningless at the FDA's Office of Hematology and Oncology Products, which has almost consistently for the past year or two leaped ahead of those timelines and approved cancer medicines well ahead of schedule – the most recent being AstraZeneca PLC's lung cancer drug Tagrisso (osimertinib).

You may also be interested in...

AstraZeneca On Tagrisso's Milestone Advance Into Adjuvant Lung Cancer

Oncology business unit head David Fredrickson talked to Scrip about Tagrisso’s approval as the first targeted adjuvant treatment for patients who have NSCLC with EGFR mutations.

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.


Related Companies

Latest Headlines
See All



Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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