India Drug Makers Learn Lesson, Correct Production Process For U.S. FDA
This article was originally published in PharmAsia News
The spate of U.S. FDA blacklisting of India drug making facilities in the past few years appears to have to a massive cleanup as facilities of firms such as Claris Lifesciences, Dr. Reddy's Laboratories and Sun Pharma join the list of the re-approved.
You may also be interested in...
Sanofi has transformed the productivity of its R&D pipeline over the past several years, and late-stage clinical data readouts are expected in the second half of this year for new anticancer drugs, a candidate pemphigus therapy and a COVID-19 vaccine.
The psoriasis market is a tough one for bimekizumab to crack but UCB head of immunology Emmanuel Caeymaex believes the clinical package and investment in promotion will see the IL-17A and IL-17F inhibitor topple its rivals.
The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, five requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.