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FDA more cautious in approving new drugs after Vioxx

Many pharmaceutical companies and industry observers say that FDA is "quietly becoming more assertive about keeping new drugs off the market or refusing to approve new uses for existing medications" in response to criticism since the 2004 Vioxx recall, the New York Times reports.

3 Oct 2006

2007 Medicare prescription drug plans

Private health insurers that market Medicare prescription drug plans in 2007 will offer more plans, several of which will have lower premiums and more of which will provide coverage during the so-called "doughnut hole," Bush administration officials said on Friday, the New York Times reports.

3 Oct 2006

Bayer forgot to tell risks of heart surgery drug

According to the German drug giant Bayer AG, the reason the company failed to inform U.S. regulators about a study on the risks of the heart-surgery drug Trasylol was a mistake.

2 Oct 2006

FDA issues guidance for development of cell-based viral vaccines

The U.S. Food and Drug Administration (FDA) has issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines.

28 Sep 2006

Michigan Senate approves bills that would require girls to receive HPV vaccine before entering sixth grade

The Michigan Senate on Wednesday voted 36-1 to approve two bills (SB 1416, SB 1417) that would require girls in the state entering the sixth grade in the 2007-2008 school year and beyond to have received Merck's human papillomavirus vaccine Gardasil, the AP/Detroit Free Press reports (AP/Detroit Free Press, 9/20).

26 Sep 2006

HPV vaccine Gardasil approved for sale in EU

The European Commission on Friday approved Merck's human papillomavirus vaccine Gardasil for sale and marketing in the European Union, London's Guardian reports (Batty, Guardian, 9/22).

26 Sep 2006

Bill to allow U.S. residents to bring prescription drugs across the Canadian border

Mary Agnes Carey, associate editor of CQ HealthBeat, discusses an appropriations bill that would allow U.S. residents to bring prescription drugs across the Canadian border, legislation to reauthorize NIH and the pending approval of Andrew von Eschenbach to head FDA in this week's "Health on the Hill from kaisernetwork.org and CQ."

26 Sep 2006

Roche to transfer technology for Saquinavir to three generic drug companies in Africa

Switzerland-based pharmaceutical company Roche on Friday said it will provide three generic drug companies in sub-Saharan Africa assistance in producing the protease inhibitor saquinavir under its Technology Transfer Initiative, Reuters South Africa reports (Reuters South Africa, 9/22).

26 Sep 2006

Report says FDA not up to scratch

According to a new report by the Institute of Medicine (IOM), despite the debacle following the drug Vioxx which was withdrawn from the market two years ago, few lessons have been learned and the Food and Drug Administration (FDA) in the U.S. still lacks the power and resources to adequately monitor the safety of newly-approved drugs.

25 Sep 2006

Senate HELP committee approves Von Eschenbach nomination to head FDA

The Senate Health, Education, Labor and Pensions Committee on Wednesday by voice vote approved President Bush's nomination of acting FDA Commissioner Andrew von Eschenbach to permanently head the agency, but potential holds to a full Senate vote on the nomination remain, the New York Times reports (Harris, New York Times, 9/21). Sen. Jim DeMint (R-S.C.)

22 Sep 2006

Many Medicare beneficiaries lack coverage in prescription drug benefit 'doughnut hole'

Eighty-eight percent of Medicare beneficiaries enrolled in stand-alone drug plans under the Medicare prescription drug benefit are in plans that do not provide coverage during the so-called "doughnut hole," according to a report released on Thursday by Democrats on the House Ways and Means Committee, the AP/Boston Globe reports.

22 Sep 2006

Prices on medications most commonly used by older people rose 4.3% in first half of 2006

Manufacturer prices for the brand-name drugs most commonly used by individuals ages 50 and older increased by an average of 6.3% during the 12-month period ending in June, according to an AARP survey released on Tuesday, the Newark Star-Ledger reports.

22 Sep 2006

Inclusion of prescription drug reimportation provision in delaying action on homeland security appropriations

Provisions that would permit U.S. residents to purchase lower-cost prescription drugs from abroad have become a "major sticking point" to settling negotiations on the House and Senate fiscal year 2007 Homeland Security appropriations bills, CongressDaily reports (CongressDaily, 9/19).

22 Sep 2006

GSK seeks regulatory approval in U.S., Europe for Tykerb

GlaxoSmithKline on Monday said it has submitted its experimental breast cancer drug Tykerb, which is taken orally, for FDA approval and plans to file for approval in Europe in the fourth quarter of this year, Reuters reports.

20 Sep 2006

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

Pharmaceutical News

FDA more cautious in approving new drugs after Vioxx

2007 Medicare prescription drug plans

Bayer forgot to tell risks of heart surgery drug

FDA issues guidance for development of cell-based viral vaccines

Michigan Senate approves bills that would require girls to receive HPV vaccine before entering sixth grade

HPV vaccine Gardasil approved for sale in EU

Bill to allow U.S. residents to bring prescription drugs across the Canadian border

Roche to transfer technology for Saquinavir to three generic drug companies in Africa

Report says FDA not up to scratch

Senate HELP committee approves Von Eschenbach nomination to head FDA

Many Medicare beneficiaries lack coverage in prescription drug benefit 'doughnut hole'

Prices on medications most commonly used by older people rose 4.3% in first half of 2006

Inclusion of prescription drug reimportation provision in delaying action on homeland security appropriations

GSK seeks regulatory approval in U.S., Europe for Tykerb

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

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