Mentor Hyalite dermal filler
This article was originally published in The Gray Sheet
Executive Summary
Pivotal study commences of the non-animal stabilized hyaluronic acid dermal filler, comparing the device with Medicis' approved Restylane HA filler. Six-month data from the 12-month study will be submitted in support of a planned PMA application for facial wrinkle correction and lip augmentation. The latter application would be a first for an HA filler. Hyalite includes lidocaine anesthetic to alleviate pain during injection. Mentor acquired the device via its August 2003 acquisition of Vitrolife AB subsidiary A-Life (1"The Gray Sheet" Sept. 8, 2003, p. 19)...
You may also be interested in...
Medicis Lab-Derived Dermal Filler On Track For Year-End Approval – Exec
Medicis will hire a 30-40 rep sales force for Q-Med's Restylane non-animal stabilized hyaluronic acid (NASHA)-based surgical wrinkle treatment in time for the product's launch, anticipated by 2004
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.