PHARMACY

Senate votes to extend current SCHIP legislation through March 2009

BY Drew Buono

WASHINGTON The Senate on Tuesday approved a bill unanimously that will extend the State Children’s Health Insurance Program through March 2009, according to reports. The House of Representatives plans to look at the issue before the end of the year.

This extension will end a battle for now with President Bush, who had twice vetoed the bill, including the most recent veto last week. Bush vetoed the program the second time because he felt the second version was too similar to the first and would cost too much money as well as shift children from the private marketplace to government run programs.

The bill also would stop a scheduled 10 percent pay cut for Medicare doctors for six months and provide a 0.5 percent increase instead. The health legislation costs about $6 billion, but was paid for by savings in other health programs.

The program currently covers about 6.6 million poor children.

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Mylan, Forest get FDA approval of Bystolic for hypertension

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved Mylan and Forest Labs’ new drug, nebivolol, for the treatment of high blood pressure. Forest will market the drug under the prescription name Bystolic.

Nearly 1-in-3 adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack and kidney failure. “High blood pressure is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” said Douglas Throckmorton, the FDA’s deputy director of the Center for Drug Evaluation and Research. “Bystolic offers a new treatment option for people who need to control their high blood pressure.”

More than 2,000 people received Bystolic during clinical trials. The drug’s efficacy was similar to that of other approved beta blockers, the FDA said. The most common reported side effects were headache, fatigue, dizziness and diarrhea.

On Dec. 2 of this year, Forest and Mylan had said that final approval was contingent upon resolution of manufacturing deficiencies at a plant in Belgium.

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Genzyme gets expanded approval for Thyrogen from FDA

BY Drew Buono

CAMBRIDGE, Mass. The Food and Drug Administration has granted expanded approval for Genzyme’s thyroid cancer drug Thyrogen, according to published reports.

The new indication allows for Thyrogen (thyrotrophin) to be used in combination with radioiodine, a radioactive iodine used to treat thyroid cancer, to destroy the remaining thyroid tissue in patients who have had their cancerous thyroids removed.

Thyrogen was initially approved in the U.S. in 1998 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The drug helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal.

“This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence,” said Mike Heslop, senior vice president and general manager of Genzyme’s endocrine business.

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