SCOLR IND
This article was originally published in The Tan Sheet
Executive Summary
Bellevue, Wash.-based firm has submitted an investigational new drug application with FDA in advance of conducting studies on extended-release ibuprofen in humans, the firm announces. The trial is slated to begin in early 2005, with an NDA submission planned for the summer, SCOLR adds. The firm initially aimed to begin human trials in Canada this fall (1"The Tan Sheet" Aug. 2, 2004, p. 12)...
You may also be interested in...
Ibuprofen Extended-Release NDA Slated For 2005, SCOLR Pharma Says
SCOLR Pharma plans to file an NDA in summer 2005 for CDT extended-release 12-hour ibuprofen tablets, the firm announced July 26
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.