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FDA advisory panel recommends approval of experimental preterm labor prevention drug

An FDA advisory committee on Tuesday voted 13-8 that clinical trial data regarding Adeza's experimental preterm labor prevention drug Gestiva was adequate to approve the drug, Dow Jones reports (Corbett Dooren, Dow Jones, 8/29).

30 Aug 2006

Schering-Plough to pay $435M and plead guilty to conspiracy

Schering-Plough on Tuesday agreed to pay $435 million and plead guilty to criminal conspiracy charges to settle a federal investigation into the company's marketing practices and Medicaid charges, the AP/Houston Chronicle reports (AP/Houston Chronicle, 8/30).

30 Aug 2006

FDA forms task force on human tissue safety

The Food and Drug Administration (FDA) today announced the formation of a multidisciplinary FDA task force on human cell and tissue safety.

30 Aug 2006

Ortho-McNeil to lower the price of contraceptive pills and patches

Ortho-McNeil - which supplies contraceptives to the majority of family planning clinics nationwide - on Thursday announced it will lower the price of its contraceptive pills and patches, according to officials, the Chicago Tribune reports.

30 Aug 2006

History of cervical cancer, HPV vaccine development

The New York Times on Tuesday examined the development of vaccines to prevent transmission of the human papillomavirus, which can cause cervical cancer.

30 Aug 2006

FDA questions effectiveness of Gestiva at preventing preterm labor

FDA in a review of Adeza's experimental preterm labor prevention drug Gestiva said the drug seems to reduce deliveries before 37 weeks' gestation but not births before 32 or 35 weeks' gestation, according to documents posted Monday on the agency's Web site.

30 Aug 2006

Officials say PhRMA funded U.S. Chamber of Commerce ads touting Medicare prescription drug benefit

"[P]olitical officials" allege that the Pharmaceutical Research and Manufacturers of America gave money to the U.S. Chamber of Commerce to support an advertising campaign that praises senators and House members who voted for the 2003 Medicare law, the AP/San Jose Mercury News reports.

30 Aug 2006

FDA approves generic Ciprofloxacin injection

The Food and Drug Administration has approved several Abbreviated New Drug Applications (ANDAs) for generic versions of Bayer Corporation Pharmaceutical Division's CIPRO I.V., a drug to treat certain bacterial infections.

29 Aug 2006

How safe is drug which prevents pre-term births? FDA will soon find out

Questions have been raised in the U.S. over the safety and effectiveness of a hormone based drug which is used in women who have a history of pre-term births.

29 Aug 2006

New England Journal of Medicine examines West Virginia's new Medicaid program

Two perspective pieces from the New England Journal of Medicine examine West Virginia's new Medicaid program, which will allow 160,000 Medicaid beneficiaries -- many of whom are parents of children enrolled in the program -- to sign a "personal responsibility contract."

28 Aug 2006

Problems persist with Maine Medicaid computerized billing system

Up to 10% of Medicaid payments made to providers through Maine's computerized bill-paying system are not processed correctly because of glitches in the system, state Medicaid officials have said, the Bangor Daily News reports.

28 Aug 2006

Australian girls lead the field in cervical cancer vaccination programme

Australian females will be one jump ahead of some of their counterparts elsewhere in the world with the first vaccinations against cervical cancer taking place in Brisbane today.

28 Aug 2006

Cervical cancer vaccine tipped for nine year olds

Health experts in the UK are considering vaccinating young girls of primary school age against the human papilloma virus.

28 Aug 2006

West Virginia revisions to Medicaid programs examined

NPR's "Morning Edition" on Tuesday examined revisions to the Medicaid programs in Kentucky and West Virginia, which are the first two states to revise their programs under a new federal law that allows states increased flexibility in determining benefits and out-of-pocket costs (Rovner, "Morning Edition," NPR, 8/22).

24 Aug 2006

A close look at Accutane drug registry iPledge

The Chicago Sun-Times on Monday examined the online FDA tracking database iPledge, with which all people taking Roche's acne drug Accutane much register to receive their prescriptions (Ritter, Chicago Sun-Times, 8/21).

24 Aug 2006

FDA approves nonprescription sales of Plan B for women over age 18

FDA on Thursday approved Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B to women ages 18 and older, the Washington Post reports.

24 Aug 2006

Legislation allowing conscientious objection for pharmacists introduced in about half of state legislatures this year; none were approved

Legislation that would have allowed pharmacists not to fill some prescriptions, such as emergency contraception, because of moral or religious objections were introduced in nearly half of the state legislatures in 2006, the Washington Times reports.

24 Aug 2006

Medicare to reduce payments to pharmacies making their own medications

Beginning in January 2007, CMS will make "significantly lower" Medicare payments to pharmacies that make compounded inhalation drugs for patients with respiratory needs, according to a letter sent on Tuesday from CMS Administrator Mark McClellan to Sen. Chuck Grassley (R-Iowa), USA Today reports.

24 Aug 2006

Women's Health Network petitions FDA to halt sales of estrogen, testosterone combination treatments

The National Women's Health Network has petitioned FDA to stop sales of Solvay's Estratest and Breckenridge Pharmaceuticals' Syntest, which are estrogen-testosterone combination therapies used to treat menopause-associated hot flashes, until they are proven safe and effective, Reuters reports.

24 Aug 2006

Lawsuit seeking to overturn FDA decision against prescription drug reimportation waiver dismissed

U.S. District Judge Alexander Williams in Greenbelt, Md., on Tuesday dismissed a lawsuit filed by Montgomery County, Md., that sought to overturn an FDA decision not to approve a waiver for a program to allow county employees to purchase lower-cost prescription drugs from Canada, the AP/Baltimore Sun reports (AP/Baltimore Sun, 8/24).

24 Aug 2006