FDA panel rejects proposal for hemoglobin levels for Amgen, J&J
WASHINGTON A panel for the Food and Drug Administration has rejected an FDA proposal for a specific target hemoglobin level for anti-anemia drugs by Amgen and Johnson & Johnson that are used for patients with kidney failure.
The vote was 14 to 5 against a question that asked whether the FDA should target a measure of red blood cells at 11 grams per deciliter in patients who are also on dialysis. Several panel members agree with the drug companies that the target range should be between 10 and 12 grams.
Paul Eisenberg, Amgen’s vice president of global regulatory affairs and safety, said “we believe the data do demonstrate there is risk when you target a hemoglobin above 13 (grams), but achieving a target of greater than 11 grams per deciliter is associated with better outcomes” explaining why the companies are seeking a range of 10 grams to 12 grams.
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.