GlaxoSmithKline to pay states $229M to wrap Avandia suits, other claims

Tracy Staton GlaxoSmithKline has wrapped up another set of Avandia lawsuits. The drugmaker said it reached a deal with 8 state attorneys general to resolve lawsuits involving the controversial ...

GSK Statement in Response to Vote on Availability of Avandia

barbara.lempert GSK Statement in Response to FDA Advisory Committee’s Vote on Availability of Avandia (Rosiglitazone) PHILADELPHIA, June 6, 2013 – GlaxoSmithKline [NYSE: GSK] ...

FDA advisors vote for looser reins on GlaxoSmithKline’s Avandia

Carly Helfand It took multiple tries and a vote tallied on paper to make sure everything was correct, but finally, we have a verdict. After two days of hearings, on Thursday an advisory ...

FDA official, panelists challenge Avandia safety trial

Carly Helfand Dr. Thomas Marciniak, medical team leader of FDA's Division of Cardiovascular and Renal Products, made some expensive promises Wednesday morning. FiercePharma News

FDA officials divided on Avandia safety as panel meeting looms

Carly Helfand Ahead of this week's FDA advisory panel meeting, staff reviewers backed a readjudication of the controversial RECORD trial, which found that the GlaxoSmithKline diabetes ...

Avandia, An FDA War Of Words And ‘Unprofessional Language’

esilverman The enmity between Tom Marciniak, an FDA medical reviewer, and his supervisors at the agency, is on full display in a remarkable set of memos that the agency has ...

Glaxo’s Stewart On Avandia Meeting: ‘There’s A Logical Conclusion’

esilverman A controversial FDA advisory committee meeting will take place this week to determine whether restrictions on the Avandia diabetes pill should be removed, continued, ...

Reanalyzed Avandia data shows no increased heart risks

Tracy Staton The new analysis of Avandia safety data has made its debut. Verdict: The GlaxoSmithKline diabetes drug does not increase cardiovascular risk. What's that, you say? ...

FDA responds to one small piece of Avandia criticism

Carly Helfand FiercePharma News

Why is the FDA holding Avandia hearings? Agency critic has ideas

Tracy Staton Publicly disgraced after cardiologist Steven Nissen and his colleagues unveiled data on its cardiovascular risks in 2007, Avandia was withdrawn in Europe and put under ...

Steve Nissen: The FDA Meeting On Avandia Will Be A ‘Whitewash’

esilverman Next month, the FDA will hold a two-day meeting to discuss the results of a clinical trial for the Avandia diabetes pill, three years after the agency greatly restricted ...

FDA taking new look at Avandia risks

Eric Palmer Once Avandia‘s heart risks were fully understood, the former blockbuster from GlaxoSmithKline ($ GSK), was tightly restricted in the U.S. and pulled from the European ...
© 2017 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS