Shionogi To File HIV Integrase Inhibitor Dolutegravir In U.S. And Europe By Year End
This article was originally published in PharmAsia News
Shionogi Pharmaceuticals announced Oct. 4 it plans to file an application for new HIV integrase inhibitor dolutegravir (development code S-349572) in the United States and Europe in 2012.
You may also be interested in...
October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.
Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.