Abraxis receives tentative FDA approval for generic Kytril
SCHAUMBURG, Ill. Abraxis BioScience’s hospital business Abraxis Pharmaceutical Products has received tentative approval from the Food and Drug Administration for a generic version of the drug Kytril.
Granisetron hydrochloride, the generic of Kytril, is used for the prevention of nausea and vomiting in patients associated with cancer therapy and radiation. The brand, which is made by Hoffmann-La Roche is set to lose its patent on Dec. 29 or on June 28, 2007, if the company receives pediatric exclusivity.
Barr Pharmaceuticals has also received a tentative approval for a generic of Kytril.
House, Senate pass patent reform bills; industry opposes
WASHINGTON The House of Representatives has passed the Patent Reform Act by a vote of 220-175.
Along with its Senate counterpart, S. 1145, industry leaders have viewed the bill as a means of making the pharmaceutical industry a “much more friendly place for infringers,” said Biotechnology Industry Organization president and chief executive officer Jim Greenwood.
The organization opposes the bill because, it “puts a risk a whole host of innovators,” said Greenwood. The Bush administration has concerns over the bill regarding limiting court discretion over awards and the Generic Pharmaceutical Association also has concerns over the bill according to president and chief executive officer Kathleen Jaeger.
The administration on Monday had criticized a provision changing how damages are calculated in infringement suits, criticizing the limiting of courts in determining damages. “Making this change to a reasonably well-functioning patent legal system is unwarranted and risks reducing the rewards from innovation—a result that would undercut the other useful reforms in this bill,” it said in a statement.
Novelos patents proprietary oxidized glutathione structure
NEWTOWN, Mass. Novelos Therapuetics announced that the U.S. Patent and Trademark Office had issued a patent number for a compound named NOV-002.
“This most recent addition to our IP portfolio further strengthens Novelos’ proprietary position in the oxidized glutathione field in general and, in particular, around the structure of NOV-002,” said Christopher Pazoles, Ph.D, vice president of research and development of Novelos. “It will also allow us to expand our pipeline to include additional compounds based on this structural motif.”
This is Novelos lead compound in Phase 3 trial for non-small cell lung cancer. Novelos is a biopharmaceutical company focusing on the development of remedies for cancer and hepatitis.