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
UsernamePublicRestriction

Bayer aspirin MI petition

This article was originally published in The Tan Sheet

Executive Summary

FDA should evaluate collected study data on aspirin for primary prevention of myocardial infarction "expeditiously," Bayer urges in Feb. 22 comments supporting the firm's petition to amend professional labeling to include the indication. The firm submitted data and protocols from five major prevention trials through Colin Baigent, MD, of Oxford's Clinical Trials Study Unit. Baigent previously presented a meta-analysis of the trials at a December 2003 meeting of the Cardiovascular & Renal Drugs Advisory Committee, convened to consider Bayer's petition (1"The Tan Sheet" Dec. 15, 2003, p. 4). The panel voted 11-3 against the new labeling, but the agency requested more information at an April 2004 feedback meeting...

You may also be interested in...



Aspirin For MI Primary Prevention Indication Needs More Study, Panel Says

A long-term randomized prospective trial of at least 15,000 patients would be needed to adequately support professional aspirin labeling on primary prevention of myocardial infarction, according to members of FDA's Cardiovascular & Renal Drugs Advisory committee

Finance Watch: 2020 IPOs Surpass 2019 Total With 52 To Date

ES: Public Company Edition: Fifty biopharma companies launched initial public offerings in the US last year and there have been 52 so far in 2020, including Metacrine, Dyne, Athira and COMPASS.

COVID-19 Shows Remote Monitoring Can Work For Pre-Cert Program

In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.

Topics

UsernamePublicRestriction

Register

LL1133951

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