In Brief: Gensia Sicor
This article was originally published in The Gray Sheet
Executive Summary
Gensia Sicor: Receives approvable letter from FDA for its GenESA arbutamine drug infusion system for the additional indication of use with echocardiography in the diagnosis of coronary artery disease in patients who cannot exercise adequately. The notice follows an earlier approvable letter for a new drug application for use of the system in diagnosis of coronary artery disease with radionuclide myocardial perfusion imaging ("The Gray Sheet" May 26, I&W-7). Clearance of both indications is contingent upon FDA's approval of final labeling. GenESA, slated for launch during the third quarter, will be marketed by the 25-person sales force of Gensia's Automedics subsidiary at a price of $15,000...
You may also be interested in...
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.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.