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

UsernamePublicRestriction

Lilly Gains New Indication For Forteo, But Also A REMS And Patient Registry

Executive Summary

Lilly is setting up a voluntary Forteo patient registry to collect data on potential bone cancer risk as part of FDA's approval of a new indication for the osteoporosis treatment. The company is also instituting a Risk Evaluation and Mitigation Strategy to control for the risk

You may also be interested in...



Deal Watch: Sanofi And Evotec Negotiate Alliance Aimed At Improving Drug Discovery

Janssen licenses a rheumatoid arthritis program from Modern Biosciences that could address the inflammatory and bone-destruction manifestations of the disease, while Japan’s Otsuka buys Avanir on the strength of its neuroscience pipeline. Meanwhile, previously signed Astellas/Janssen and Novartis/Array agreements are terminated.

Regenerating Interest In Novel Drugs For Postmenopausal Osteoporosis

New bone-targeted agents for osteoporosis must clear significant obstacles to succeed in a highly generic market, but safety concerns with established agents like bisphosphonates and calcitonin offer a foothold. Phase III anabolic candidates from Amgen and Radius Health aim to build new bone, the holy grail of osteoporosis treatment, but R&D in new anti-resorptive mechanisms to halt bone breakdown also continues.

Registries Rising: FDA Looking At TNF Inhibitors; AHRQ Updates Standards

The FDA Amendments Act of 2007 gave the agency many new safety powers and the potential for promotional restrictions and post-marketing fines have understandably received much industry attention. But FDA also appears to be drawing upon its beefed-up authority to increase use of a much older, low-tech safety effort: the patient registry

Related Content

Topics

UsernamePublicRestriction

Register

PS051412

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