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Use of unapproved drugs in the U.S.

USA Today on Monday looked at the use of unapproved drugs in the U.S., including some that are used to treat menopause symptoms (Rubin, USA Today, 9/18).

20 Sep 2006

Jury dismisses lawsuit against Wyeth in first Pempro case

A jury in a U.S. District Court in Little Rock, Ark., on Friday dismissed negligence charges in the first of about 5,000 lawsuits filed over Prempro, a combination hormone replacement therapy manufactured by Wyeth, and found the drug's design was not defective, Reuters reports.

20 Sep 2006

Many Australian physicians not applying for permission to import Mifepristone

Many Australian physicians are not applying for permission to supply mifepristone to women in the country and instead are prescribing women a combination of methotrexate -- a drug licensed to treat cancer patients -- and misoprostol to induce a medical abortion.

20 Sep 2006

Some Senators concerned about plan to address Medicare premium refund checks sent erroneously

Some senators have raised concerns that a plan developed by CMS Administrator Mark McClellan and Social Security Administration Commissioner Jo Anne Barnhart to address errors in the deduction of Medicare prescription drug benefit premiums from Social Security checks "might be too harsh" for low-income beneficiaries, The Hill reports.

20 Sep 2006

Medical Centers should follow Stanford's lead in banning gifts from drug companies

Stanford University Medical Center's decision to prohibit physicians from accepting any gifts from pharmaceutical sales representatives is "an austere measure that other medical centers should follow," a Los Angeles Times editorial states.

20 Sep 2006

Thousands of prescription drug products sold in the U.S. not approved by FDA

Drugs that have not been approved by FDA make up nearly 2% of prescription drugs on the market, and some of them "might not only be ineffective but also might actually be harmful," USA Today reports.

20 Sep 2006

Insurance companies promote use of generic drugs in effort to cut costs

The Chicago Tribune on Sunday examined how some private insurers, in an attempt to reduce health care costs by encouraging the use of generic drugs, "are showering customers with free generic drug samples, waiving copayments and marketing directly to consumers in doctors' offices."

20 Sep 2006

FDA approves Noxafil (posaconazole) to prevent invasive fungal infections

The U.S. Food and Drug Administration has approved Noxafil (posaconazole) to prevent fungal infections caused by certain molds and yeast-like fungus called Aspergillus and Candida.

19 Sep 2006

Sen. DeMint pledges to hold Von Eschenbach's FDA Commissioner nomination unless steps taken to take Mifeprex off market

Sen. Jim DeMint (R-S.C.) plans to place a hold on President Bush's nomination of acting FDA Commissioner Andrew von Eschenbach to permanently head the agency unless "immediate steps" are taken to remove Danco Laboratories' medical abortion drug Mifeprex from the market, DeMint press secretary Wesley Denton said recently, the New York Times reports.

18 Sep 2006

House subcomittee hearing focuses on disciplinary measures for NIH scientists' ethnics violations

NIH officials have not adequately disciplined agency scientists found to have violated ethics rules, members of the House Energy and Commerce Subcommittee on Oversight and Investigations said at a hearing last Wednesday.

18 Sep 2006

Oregon Prescription Drug Program would expand coverage to all uninsured residents

An initiative that will appear on the November ballot in Oregon would expand a state prescription drug program to cover all residents without drug coverage, the Oregonian reports.

18 Sep 2006

Zimbabwean antiretroviral drug manufacturers seeking WHO certification to receive U.N. funding

Zimbabwean antiretroviral drug manufacturers are seeking certification from the World Health Organization to receive U.N. and other multilateral agency funding to produce more affordable antiretroviral drugs.

18 Sep 2006

GSK to supply antiretroviral drugs to Russia at discounted price

GlaxoSmithKline has announced it would supply 90,000 packs of its antiretroviral drugs Combivir, Epivir and Ziagen to Russia at discounted prices by the end of 2006, the AFP/Yahoo! U.K and Ireland reports (AFP/Yahoo! U.K and Ireland, 9/15).

18 Sep 2006

More physicians now visit web sites to find information on brand-name prescription drugs

An increased number of physicians visited Web sites that promote brand-name prescription drugs during the first six months of 2006 to seek information about dosages and side effects, according to a recent Manhattan Research study, the Newark Star-Ledger reports.

18 Sep 2006

Chile to distribute Plan B emergency contraceptive at no cost to girls over age 14

Chilean Health Minister Maria Soledad Barria earlier this month announced that the government will distribute Barr Laboratories' emergency contraceptive Plan B -- which can prevent pregnancy if taken up to 72 hours after sexual intercourse -- in public clinics to girls ages 14 and older at no cost and without parental consent, the Christian Science Monitor reports.

14 Sep 2006

Bristol-Myers Squibb and Medivira announce collaboration to commercialize HIV treatment

Bristol-Myers Squibb and Medivir AB have announced a worldwide collaboration to develop and commercialize MIV-170, a preclinical non-nucleoside reverse transcriptase inhibitor, or NNRTI, intended for the treatment of HIV-1 infection in adults as part of an antiretroviral drug regimen.

13 Sep 2006

Accutane iPledge program requirements leading to illegal online sales

The strict regulations governing the prescription and use of the acne drug isotretinoin, sold by Roche under the brand name Accutane, are affecting the drug's sale and dispensation and raising concerns about sales of the medication over the Internet, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 9/12).

13 Sep 2006

Department of Justice joins Whistleblower lawsuit alleging overcharging by drug company Dey

The Department of Justice on Monday joined a whistleblower lawsuit filed against California-based Dey, a generic medication division of Germany-based Merck KGaA, over allegations that the company inflated prices reported to federal health insurance programs, the Boston Globe reports.

13 Sep 2006

GlaxoSmithKline settles dispute with IRS

GlaxoSmithKline has announced that it has settled its transfer pricing tax dispute with the US Internal Revenue Service (IRS).

12 Sep 2006

TV advertising of prescription drugs may increase visits to doctor not actual sales

TV advertising of prescription drugs may be prompting more people to visit their doctors rather than substantially increasing sales of advertised drugs, according to research led by the Medical University of South Carolina (MUSC).

12 Sep 2006

Pharmaceutical News

Use of unapproved drugs in the U.S.

Jury dismisses lawsuit against Wyeth in first Pempro case

Many Australian physicians not applying for permission to import Mifepristone

Some Senators concerned about plan to address Medicare premium refund checks sent erroneously

Medical Centers should follow Stanford's lead in banning gifts from drug companies

Thousands of prescription drug products sold in the U.S. not approved by FDA

Insurance companies promote use of generic drugs in effort to cut costs

FDA approves Noxafil (posaconazole) to prevent invasive fungal infections

Sen. DeMint pledges to hold Von Eschenbach's FDA Commissioner nomination unless steps taken to take Mifeprex off market

House subcomittee hearing focuses on disciplinary measures for NIH scientists' ethnics violations

Oregon Prescription Drug Program would expand coverage to all uninsured residents

Zimbabwean antiretroviral drug manufacturers seeking WHO certification to receive U.N. funding

GSK to supply antiretroviral drugs to Russia at discounted price

More physicians now visit web sites to find information on brand-name prescription drugs

Chile to distribute Plan B emergency contraceptive at no cost to girls over age 14

Bristol-Myers Squibb and Medivira announce collaboration to commercialize HIV treatment

Accutane iPledge program requirements leading to illegal online sales

Department of Justice joins Whistleblower lawsuit alleging overcharging by drug company Dey

GlaxoSmithKline settles dispute with IRS

TV advertising of prescription drugs may increase visits to doctor not actual sales

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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