Medtech Insight 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
UsernamePublicRestriction

HCFA

This article was originally published in The Gray Sheet

Executive Summary

Requirement that patients demonstrate adaquate renal, hepatic, pulmonary and cardiac function in order to be eligible for national coverage for autologous stem cell transplantation (AuSCT) for multiple myeloma is sufficient, and HCFA will not reinstate a cut-off at age 77, the agency decides Feb. 9. Age was to serve as a proxy for predicting who would be susceptible to co-morbidities associated with the procedure; however, HCFA canceled the age restriction Oct. 1, 2000, saying it would try instead to identify specific co-morbidities through an internal review

You may also be interested in...



Sun's Halol Site Faces FDA Action

FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.

Dr Reddy’s And Hikma Win Big On US Vascepa Patents

In a surprise to the market, Dr Reddy’s and Hikma have prevailed in challenging six method-of-use patents shielding Amarin’s Vascepa in the US, opening the door for a potential at-risk launch that would likely be challenged by the originator.

Manipulating Metabolism: Lilly Links With UK Biotech Sitryx

Duo will study up to four novel preclinical targets identified by Sitryx that may lead to potential new drugs for autoimmune diseases, which Lilly would then commercialize.

UsernamePublicRestriction

Register

MT014527

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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