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Human Genome Hep C Drug Approval Unlikely: BioBuzz

FDA sends Human Genome a "Discipline Letter" critical of the hepatitis C drug Zalbin.



) --

Human Genome Sciences


conceded Monday that U.S. regulators are unlikely to approve its experimental hepatitis C drug Zalbin.

The U.S. Food and Drug Administration sent Human Genome a "Discipline Review" letter in which the agency expressed concerns with the risk-benefit profile of Zalbin, a longer-acting interferon designed for every-two-week dosing by patients undergoing hepatitis C treatment.

"Although the BLA

Biologic License Application review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely," the company said in a statement.


(NVS) - Get Report

, Human Genome's marketing partner for Zalbin, previously withdrew an approval application for the drug in Europe.

The FDA is expected to issue an approval decision on Zalbin on Oct. 4. Human Genome did not say Monday whether the company will withdraw its application given the FDA's letter.

Human Genome and partner


(GSK) - Get Report

have submitted the lupus drug Benlysta for approval in the U.S. and Europe.

Human Genome shares closed Friday at $26.51.

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(Updated at 7:23 AM EST)

Onyx Drug Fails Key Lung Cancer Study

Onyx Pharmaceuticals


and the German drug firm


said Monday that their cancer drug Nexavar failed to prolong the survival of lung cancer patients in a phase III study.

This is the second time that Nexavar has failed to help patients live longer in a late-stage lung cancer study.

Monday's results came from the so-called "Nexus" study, which tested Nexavar plus the chemotherapy drugs cisplatin and gemcitabine against the chemo combination on its own in patients with newly diagnosed non-small cell lung cancer. Treatment with Nexavar did not help patients live longer -- the study's primary endpoint -- although the time before patients' tumors started to grow again was extended, the companies said.

A previous phase III lung cancer study of Nexavar combined with a different chemo regimen similarly failed to boost patient survival. The companies said Monday that additional clinical studies in lung cancer continue.

Nexavar is approved for the treatment of kidney cancer and liver cancer.

Onyx is expected to release top-line results from a pivotal study of its multiple myeloma drug carfilzomib later this year.

Onyx shares closed Friday at $22.83.

-- Reported by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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