ARTICLE | Company News

Halozyme, Baxter sales and marketing update

September 6, 2010 7:00 AM UTC

Halozyme lifted its notice of Baxter's breach of contract after completing an investigation into the cause of flake-like particles, identified as glass, observed in vials of Hylenex recombinant human PH20 hyaluronidase enzyme. Halozyme said it was "pleased" with how the two companies were working together to resolve the issues, but would not disclose further details. The companies plan to meet with FDA to seek concurrence on Halozyme's proposed corrective action plan and regulatory strategy to reintroduce Hylenex to the market. In May, Halozyme and Baxter recalled all manufactured lots of Hylenex after the particles were observed during stability testing (see BioCentury, May 24). ...