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ImClone, BMS revise U.S. prescribing info of cancer drug

BY Alaric DeArment

NEW YORK The Food and Drug Administration has approved changes to the prescribing information for a biotech drug used to treat cancers, in light of analyses showing the drug to be ineffective in colorectal cancer patients, whose tumors include a certain gene mutation.

ImClone Systems and development partner Bristol-Myers Squibb announced revisions to the U.S. version of the prescribing information for Erbitux (cetuximab) Monday in light of analyses showing that the drug may not work for patients with metastatic colorectal cancer that includes the epidermal growth factor receptor, also known as EGFR, and whose tumors include the K-ras gene mutation.

The American Society of Clinical Oncology and the National Comprehensive Cancer Network recently issued guidelines recommending that metastatic colorectal cancer patients be tested for the K-ras mutation before receiving anti-EGFR monoclonal antibodies, the class of drugs that includes Erbitux.

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Report: Card-check provision removed from Employee Free Choice Act

BY Michael Johnsen

NEW YORK The New York Times on Friday reported that the “card-check provision” — which would have required employers to recognize a union as soon as a majority of workers signed cards saying they wanted a union as opposed to a secret-ballot election — has been removed from the Employee Free Choice Act in an effort to secure enough Democratic votes to avoid a filibuster.

It was a polarizing issue — the card-check provision was advocated by union organizations because it would have made it easier to unionize a workforce. In its place, several Senate and labor officials told the New York Times, the revised bill would require shorter unionization campaigns and faster elections — with elections to be held within two work-weeks after 30% of a workforce signed cards favoring unionization.

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Gilead enters partnership with Tibotec to develop HIV drug

BY Allison Cerra

FOSTER CITY, Calif. Gilead Sciences said it entered a partnership with Tibotec Pharmaceuticals to develop a single daily antiretroviral HIV pill.

The proposed drug would combine Gilead’s Truvada with a drug Tibotec is developing called TMC278, or rilpivirine. Terms were not disclosed, but Gilead said it would take the lead in manufacturing and testing the combined drug, working to get it approved by regulators, and selling it.

Gilead said the product would be the second complete antiretroviral treatment for HIV available in one pill. The first is Gilead’s Atripla, which combines three HIV drugs. The company said the combined pills make treatment simpler for patients.

Tibotec, a unit of Johnson & Johnson, would be responsible for developing rilpivirine as a standalone drug.

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