Cardio-Renal panel to address Revatio, phosphate binders
Executive Summary
FDA's Cardiovascular and Renal Drugs Advisory Committee will meet Oct. 16 to discuss extending the use of phosphate binders to the pre-dialysis population. Shire, Genzyme and Fresenius - all of whom have phosphate binders approved for use in controlling serum phosphorus levels in dialysis patients - are scheduled to speak at the first day of the meeting. Genzyme has an NDA pending for Renagel (sevelamer) follow-on Renvela for the pre-dialysis indication. Fresenius markets PhosLo (calcium acetate) and Shire markets Fosrenol (lanthanum) in the United States. The panel will also discuss data requirements and study designs for a pediatric indication for Pfizer's Revatio (sildenafil) in pulmonary arterial hypertension Oct. 17...
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.