Pink Sheet 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


Amgen's Denosumab: Quick Takes from FDA's Advisory Committee Meeting

This article was originally published in RPM Report

Executive Summary

FDA’s Reproductive Health Products Advisory Committee meeting on Amgen’s osteoporosis drug could have derailed denosumab’s prospects at a number of key turning points. But Amgen’s presentation combined with the drug’s effi cacy profi le pushed the investigational product through a key regulatory toll gate relatively unscathed.

You may also be interested in...

ESAs in Renal Disease: Amgen Braves an Advisory Committee Storm With Another Regulator in Mind

An FDA panel was convened to re-evaluate the cardiovascular risks associated with Amgen’s Aranesp and the ESAs after a third clinical trial showed CV endpoints going in a negative direction. The company was able to emerge from the meeting with a near-best case scenario. That’s critical with a CMS coverage decision looming.

Amgen's D-mab: The New EPO

D-mab is the new EPO. At least, that's what Amgen is hoping as it awaits FDA approval for its next growth engine, denosumab (D-mab). Assuming the drug gets to market--and Amgen is very confident it will--the drug's success will depend largely on pricing.

FDA Advisory Committees on the Brink: More Meetings, Fewer Members

A year ago, Congress sent FDA two very clear, somewhat contradictory messages: Hold more advisory committee meetings, but without the use of many expert panelists used in the past. The result is a system that is stretched to the limits.


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.

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