PHARMACY

House Dems fail again to override veto on SCHIP bill

BY Drew Buono

WASHINGTON The House of Representatives has failed for the second time in three months in an attempt to override President Bush’s veto on the children’s health insurance program, according to the Associated Press. The children’s health program serves families that earn too much to qualify for Medicaid, but not enough to afford private insurance.

Democratic leaders fell 15 votes shy of obtaining the two-thirds majority vote needed for an override, the vote was 260-152. Republicans said Congress had already set aside sufficient funding to ensure that the SCHIP program would continue through March 2009 for those currently enrolled. They criticized Democrats for delaying an override vote to coincide more closely with next week’s State of the Union address from President Bush.

The legislation that Bush vetoed would have increased enrollment in the children’s health program from 6 million to 10 million over the coming five years. The revenue needed for that enrollment increase would come from a 61-cent increase in the federal excise tax on a pack of cigarettes, as well as comparable tax increases on other tobacco products.

Both sides said they were willing to sit down after the vote in an effort to reach a compromise.

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Ranbaxy, GSK settle over Imitrex litigation

BY Drew Buono

HARYANA, India Ranbaxy Laboratories has settled litigation with GlaxoSmithKline related to sumatriptan succinate tablets, the generic of GlaxoSmithKline’s drug Imitrex, according to published reports.

The settlement will allow Ranbaxy to exclusively sell the generic for 180 days starting December this year. Under the terms of the settlement, Ranbaxy can distribute a generic version of sumatriptan in 25 mg, 50 mg and 100 mg doses.

Analysts expect the company to make around $100 million in sumatriptan sales in the U.S. during the exclusivity period. Sumatriptan sales in the U.S. are worth $985 million, according to IMS data.

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FDA delays Kynapid decision pending final review

BY Drew Buono

VANCOUVER, Canada The Food and Drug Administration has delayed its decision on an application for the heart treatment drug Kynapid, according to published reports. The drug manufacturer Cardiome Pharma and its co-development partner Astellas Pharma US said yesterday that the FDA did not provide an action letter by the expected date of Jan. 19.

The application for Kynapid (vernakalant hydrochloride), based on a five-year clinical development program, was submitted in December 2006. In December 2007, the FDA’s cardiovascular and renal drugs advisory committee voted 6-2 in favor of recommending to the FDA that Kynapid be approved for the rapid conversion of acute atrial fibrillation to sinus rhythm.

“While we look forward to the FDA reaching a decision, we respect their need for additional time to review the Kynapid’s application,” said William Fitzsimmons, senior vice-president for research and development at Astellas.

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