PHARMACY

Mylan contemplates selling Dey due to Q3 loss

BY DSN STAFF

PITTSBURGH Mylan, a generic drug maker, has experienced a fiscal third-quarter-loss due to the $1.27 billion write off of acquired research and development related to acquisitions.

Shares for the company fell $1.41, or 11 percent, to $11.74 during aftermarket electronic trading, after closing down 12 cents at $13.15.

According to published reports, the loss for the quarter ended Dec. 31 totaled $1.38 billion. The company is said to possibly sell specialty business Dey LP. Selling Dey; however, will delay the launch of Perforomist, a treatment for emphysema and chronic bronchitis. This delay is predicted to hurt their earnings by 20 to 25 cents per share in 2008 to 2010.

The company is also planning to discontinue manufacturing and research at its facility in Canada, and stop manufacturing products in Puerto Rico. According to published reports, it will also stop research and development at Gerard Laboratories in Ireland and Spain.

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Senate approves bill to increase spending for American Indian healthcare

BY Drew Buono

WASHINGTON The Senate has approved a bill that would give $35 billion over the next 10 years to the Indian Health Service, which provides tribal health care for 1.8 million American Indians and Alaska Natives on reservations, according to published reports.

The bill would strengthen mental health programs and patient screening for cancer and diabetes, expand disease prevention programs and recruit nurses and doctors to serve American Indian populations. It would also modernize and build health clinics and increase tribal access to Medicare and Medicaid.

The Senate also approved an amendment by Sen. Gordon Smith, R-Ore., that would grant the Indian Health Service the authority to more evenly distribute funding for construction of its health facilities. Right now, funding only goes to about 10 states.

The House is expected to take a look at the bill later this year.

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FDA to increase oversight of post-market medications

BY Drew Buono

WASHINGTON The Food and Drug Administration has revealed a new plan called “Safety First”, which is aimed at providing more information on drugs after they hit the market, according to the Wall Street Journal.

The plan involves creating a new database listing possible side effects of drugs, along with clear schedules for following up on questions about them. Also, the FDA plans to make changes to its procedures for making certain regulatory decisions particularly those based on emerging safety worries.

The FDA’s Office of Surveillance and Epidemiology, which focuses on the safety of marketed drugs, will get some new powers. The drug safety office will get primary authority over decisions to approve drug brand names and packaging, though this change will not occur immediately. Eventually, the safety office is supposed to formally get another power as well: the ability to commission certain kinds of research, the epidemiological studies often drawn from patient databases. This could involve requiring drugmakers to do such studies, a power the FDA gained under a new law passed last year, or contracting with outside sources.

The FDA is supposed to implement a second phase to the plan, called “Safe Use,” that will focus on ensuring that drugs are used safely in the real world.

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