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

Commerce Committee opens Vioxx investigation

Executive Summary

House Energy & Commerce Committee officially opens investigation of Vioxx withdrawal with Nov. 23 letters to FDA and Merck. Committee Chair Joe Barton (R-Texas) and Ranking Member John Dingell (D-Mich.) ask FDA and Merck to submit records and internal communications including those related to safety reviews of Vioxx, the 2002 labeling change, advisory committee discussion of the drug and reviews of the 2000 VIGOR study data. The letter to Merck questions promotions for the drug and requests details on recommendations of the data safety monitoring committees of the VIGOR and APPROVe trials. The Senate Finance Committee held a hearing on Vioxx Nov. 18 (1"The Pink Sheet" Nov. 22, 2004, p. 3)...

You may also be interested in...



“Independent” Drug Safety Office Is Goal Of Senate Vioxx Investigation

The idea of an "independent" drug safety office in FDA merits consideration, Office of New Drugs Acting Director Sandra Kweder, MD, said during the Senate Finance Committee hearing Nov. 18 on Merck's withdrawal of Vioxx

Cosmetics Europe Talks Microplastic: ECHA Frustrations, ‘Value Judgments’ And International Trade Uncertainty

The European Chemicals Agency's microplastic restriction proposal received committee backing in 2020 without changes sought by the cosmetics industry, which faces €15bn in projected costs and scarce alternatives at present. It may come down to EU Member States to decide whether the ECHA restriction proposal is proportionate in balancing environmental goals and socio-economic impacts.

Roche/Genentech Keeps Commitment To External Cancer Innovation

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

Topics

UsernamePublicRestriction

Register

LL009864

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