Mentor silicone submission
This article was originally published in The Gray Sheet
Executive Summary
Mentor has filed a PMA for its Contour Profile silicone gel breast implants, firm announces April 3. The Contour implants are filled with the same Memory Gel for which Mentor received an "approvable" letter for round implants from FDA last summer. Competitor Allergan/Inamed's silicone gel breast implants also sit on a September "approvable" letter. Though neither company will speculate, analysts project FDA approval of both firms' products as early as June 2006 (1"The Gray Sheet" April 3, 2006, p. 6). Furthering its shift to aesthetics, Mentor signed an agreement with Niadyne Inc. on March 20 to distribute Niadyne's NIA 24 skin therapy products...
You may also be interested in...
Allergan Details Revenue Expectations From Newly Acquired Inamed
Allergan expects its recently completed acquisition of Inamed to add $355 mil. to $395 mil. in sales revenue this year
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.