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


Lilly Forteo launch

Executive Summary

Lilly expects to launch the osteoporosis drug Forteo "at the end of this year or early next year, depending on the timing of...approval in the fourth quarter," Exec VP August Watanabe tells analysts at Banc of America Securities Conference Sept. 10. In July, FDA's Endocrinologic & Metabolic Drugs Advisory Committee recommended the drug for the treatment of osteoporosis in postmenopausal women but said the indication should be restricted to high-risk patients and second-line use (1"The Pink Sheet" July 30, p. 3)

You may also be interested in...

Lilly Forteo Osteoporosis Indication Approval Recommended With Restrictions

Lilly's Forteo should be approved for treatment of osteoporosis in postmenopausal women but restricted either to high-risk patients or second-line use, FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended July 27.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials




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