All of the world’s top 10 pharmaceutical companies have established substantial operations in Ireland and from 2003 to today, there has been dynamic growth of biologics manufacturing in Ireland, according to IDA Ireland.
France-based DBV Technologies released positive long-term data that could boost the chances of U.S. FDA approval for the company’s Viaskin Peanut allergy treatment.
Sanofi is pressing the U.S. Food and Drug Administration to keep the company’s patient experience data consistent following a review of approved applications required by the 21st Century Cures Act.
Leeds, UK-based 4D Pharma and Merck/MSD are developing Live Biotherapeutics vaccines, a new class of medicines.
Endo International plc submitted a Biologics License Application to the U.S. Food and Drug Administration for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.
Merz North America announced today that the U.S. Food and Drug Administration accepted for filing a supplemental Biologics License Application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients.
Kyowa Hakko Kirin Co. Ltd. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for mogamulizumab to treat cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.
