Vascugel granted fast-track designation by FDA
CAMBRIDGE, Mass. — The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.
The FDA granted fast-track review status to the cell-based therapy Vascugel, made by Pervasis Therapeutics. The FDA grants the status to accelerate review of treatments for serious and life-threatening conditions, particularly those that address serious, unmet medical conditions.
Hemodialysis is used to filter the blood in patients with end-stage kidney disease, but patients can experience complications that cause clotting of the vascular access points used in hemodialysis that renders them unusuable, also known as hemodialysis access failure. Vascugel is designed to prevent this clotting.
Biovail Labs to distribute Aczone in Canada
MISSISSAUGA, Ontario — Valeant Pharmaceuticals subsidiary Biovail Labs International has licensed Canadian rights to a treatment for acne from Allergan, Valeant said Tuesday.
Under the terms of the agreement concerning the drug Aczone (dapsone) gel in the 5% strength, Biovail will pay Allergan about $500,000 Canadian dollars (about $504,693) upfront, as well as payments based on net sales.
“Aczone gel is a strong addition to our Canadian business,” Valeant CEO J. Michael Pearson said. “This compound was originally approved in 2006 and never launched into the Canadian marketplace, providing Valeant Canada with a unique opportunity to strengthen and enhance our dermatology portfolio in Canada.”
Teva reports Q4, full-year results
JERUSALEM — Drug maker Teva on Tuesday said its North American sales during the fourth quarter ended Dec. 31 drove the drug maker’s financial well-being.
Sales in North America for the fourth quarter reached $2.5 billion, accounting for 56% of total sales and representing an increase of 7% compared with the year-ago period. U.S. generic sales may have dropped 5% to $1.3 billion, but Teva noted that key contributors to the quarter’s sales included continued strong sales of generic versions of Effexor XR (venlafaxine) and Pulmicort Respules (budesonide), as well as continued solid sales of Copaxone.
For the full year, Teva said its North American sales rose 16% to nearly $10 billion.
Overall sales for the company reached nearly $4.42 billion in the fourth quarter, a 16% increase, while full-year sales rose to $16.1 billion from $13.9 billion in 2009.