Approval Recommendations Set Path For Pfizer’s Xeljanz, Japan Tobacco’s HIV Therapy In Japan
This article was originally published in PharmAsia News
Executive Summary
JT’s HIV compound comes home after being joined with Gilead combination therapy. Also approved is Nobelpharma’s glowing red in vivo diagnostic for malignant glioma.
You may also be interested in...
Gilead Compares Stribild To Prezista In Seeking Exclusivity For Fixed Dose Combinations
Gilead requests five-year marketing exclusivity for two of the components in its HIV Quad treatment Stribild; citizen petition says award should not depend on whether a new active moiety is approved first as a single entity product or as part of a fixed-dose combination.
Pfizer’s Tofacitinib Clears FDA Without Limited Indication
With FDA’s early approval of tofacitinib for rheumatoid arthritis – the first JAK inhibitor and, unlike the popular TNF inhibitors, an oral agent – the agency appears to have sided with Pfizer on many issues left up in the air after an advisory committee review.
FCPA In The China Framework Warrants Special Attention
The US Department of Justice, SEC and the Chinese government have all increased investigations of corrupt practices, and incriminating evidence is easier than ever to find. What can companies do to protect themselves?