Friday, May 9, 2008
WASHINGTON (Reuters) - Denmark's Novo Nordisk won U.S. approval to sell a new formulation of a genetically engineered protein therapy that helps the blood clot, regulators said on Friday.
The product, NovoSeven RT, can be stored at room temperature for up to two years, the Food and Drug Administration said. An older formulation had to be refrigerated.
NovoSeven RT is a genetically engineered version of Factor VIIa, a protein found in plasma that is essential for the clotting of blood.
Approved uses of NovoSeven RT include treatment of bleeding, and prevention of surgical bleeding, in certain patients with hemophilia.
Read FDA News HERE
Omrix Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, today announced financial results for the first quarter ended March 31, 2008: Read more HERE
In 2003 and 2004, Omrix entered into development, distribution and supply agreements with Ethicon Inc., a Johnson and Johnson company. The partnership agreement between OMRIX and Ethicon allows each company to do what it does best: OMRIX will manufacture products and hold regulatory licenses; Ethicon will retain exclusive sales and marketing rights in the U.S. and EU to OMRIX biosurgical products in the field of hemostasis and sealing only.