Fast AZ Tagrisso Approval Springboard For Clovis?
This article was originally published in Scrip
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...
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.
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 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.