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Nycomed awaits pending FDA approval for COPD treatment

BY Anna Mcgrath

ZURICH, Switzerland Nycomed announced it has submitted a new drug application to the Food and Drug Administration for Daxas, a once-daily treatment of symptomatic chronic obstructive pulmonary disease.

The decision for the NDA submission was made after the successful results from four Phase three trials.

In addition, Nycomed completed the submission of a marketing authorization application to the European Medicines Agency for Daxas as a once-daily oral treatment for patients with symptomatic COPD. The filing is currently under regulatory review.

According to World Health Organization, approximately 80 million people suffer from moderate to severe COPD worldwide. Additionally, WHO predicts the total death rate resulting from the medical condition could increase by more than 30% in the next 10 years unless immediate action is taken to reduce the underlying risk factors, especially smoking.

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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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