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Collaborative effort by FDA and EMEA expected to yield additional safety data when assessing new drugs

In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

15 Jun 2008

UT Southwestern investigators test groundbreaking depression research in real-world setting

UT Southwestern Medical Center psychiatry researchers have taken what they learned from their groundbreaking research on treating depression and are applying it to real-world clinical settings.

15 Jun 2008

Rural, unmarried women at higher risk for depression

Mayo Clinic research suggests unmarried women living in rural areas have lower self-rated health status than their married counterparts.

11 Jun 2008

Australian Government oddly excludes AMA again on health plans - AMA negative about plans to ease GP shortage

Government plans to expand the roles of health professionals such as nurses, pharmacists, physiotherapists and dieticians, to help address the shortage of doctors, has not surprisingly evoked a negative response from the Australian Medical Association (AMA).

11 Jun 2008

Advanced cancer patients often unaware of life expectancies, effects of chemotherapy, according to perspective

Patients with advanced cancer often are not aware of their life expectancies or the effect that chemotherapy will have on their lives, according to a perspective published on Wednesday in the Journal of the American Medical Association, USA Today reports.

11 Jun 2008

Obama, McCain discuss health care proposals

Presumptive Democratic presidential nominee Sen. Barack Obama (Ill.) and presumptive Republican presidential nominee Sen. John McCain (Ariz.) on Tuesday discussed their "sharply different approaches" to health care, the economy and other issues, the Washington Post reports (Bacon, Washington Post, 6/11). Obama promoted his health care proposal on Tuesday during a visit to St. Louis Children's Hospital (Jackson, USA Today, 6/11).

11 Jun 2008

CMS to launch Medicare pilot project that will provide physicians with incentives to use health IT

HHS Secretary Mike Leavitt on Tuesday announced the 12 cities and states that have been chosen to participate in a $150 million Medicare pilot program to encourage physicians to use electronic health records, CQ Today reports.

11 Jun 2008

Bill should be passed allowing terminally ill access to experimental drugs, journal op-ed states

The case of Sen. Edward Kennedy (D-Mass.), who has been diagnosed with brain cancer, is "identical from a regulatory standpoint to the plight of hundreds of thousands of other Americans" and "shouts to the heavens the humane necessity of urgent reform in the drug approval process to make it work better for people who have serious and terminal diseases," according to a Wall Street Journal opinion piece by Steven Walker and Ronald Trowbridge, chief adviser and adjunct scholar, respectively, of the Abigail Alliance for Better Access to Developmental Drugs.

11 Jun 2008

Massachusetts insurers to expand health plans with physician ranking system despite lawsuit

Two of Massachusetts' largest health insurers are expanding or launching health plans that feature physician ranking systems despite opposition to those systems by the Massachusetts Medical Society, the Boston Globe reports. Under such ranking systems, patients who seek care from a top-rated, or top-tiered, physician have lower copayments.

11 Jun 2008

Colorado SCHIP classified 10% of beneficiaries incorrectly, according to state auditors

Colorado auditors on Monday said that Children's Health Plan Plus, the state's version of SCHIP, incorrectly classified 10% of beneficiaries, the Denver Rocky Mountain News reports.

11 Jun 2008

House bill would allow small businesses to form statewide, nationwide pools for purchasing insurance

A bipartisan coalition of House members on Tuesday introduced a bill (HR 6210) that would allow small businesses to form statewide or nationwide pools to purchase insurance and provide them with tax credits to lower the cost of coverage, CongressDaily reports.

11 Jun 2008

U.N. Secretary-General calls for end of discrimination against, travel restrictions on people living with HIV/AIDS

United Nations Secretary-General Ban Ki-moon at the opening of the U.N. 2008 High Level Meeting on AIDS on Tuesday called on the international community to end discrimination against HIV-positive people, including travel restrictions, describing such practices as "an affront to our common humanity," Xinhuanet reports.

11 Jun 2008

Public health agencies call on G8 leaders to allocate increased resources to health programs worldwide

The heads of several organizations involved in public health issues worldwide on Tuesday called on the Group of Eight industrialized nations to invest more resources in health and disease programs, the AP/USA Today reports.

11 Jun 2008

FDA advisory panel voices concern over risks of HIV vaccine trials in teenagers

An FDA advisory panel on Monday voiced concern over the potential risks of conducting early HIV vaccine trials among teenagers in the U.S., Bloomberg reports. According to the panel, although such trials are justified in countries where HIV/AIDS is spreading more quickly, the risks might not outweigh the benefits in the U.S.

11 Jun 2008

UNAIDS Executive Director Piot to step down

UNAIDS Executive Director Peter Piot will step down from his position when his term is over at the end of the year, United Nations Secretary-General Ban Ki-moon announced on Tuesday at the United Nations 2008 High Level Meeting on AIDS in New York, Reuters reports. Piot has served as UNAIDS executive director since the organization's inception in 1995.

11 Jun 2008

Specific immune therapy works for many people with allergies

The German Institute for Quality and Efficiency in Health Care has assessed recent evidence on allergies. It found that the once controversial immune therapy against allergy symptoms can definitely help many people with allergies.

11 Jun 2008

Children in non-English-speaking households experience multiple health disparities

Children in U.S. households where English is not the primary language experience multiple disparities in health care, a UT Southwestern Medical Center researcher has found.

11 Jun 2008

Government and nurses call for a major shake-up of Australia's health system

Plans by the federal government to address the dire shortage of general practitioners by making better use of other health professionals is in some ways in line with calls from the Australian Nursing Federation (ANF) for a major reform to the way health services are funded and delivered.

11 Jun 2008

The Politico examines prospects for U.S. health care system overhaul

The Politico on Tuesday examined how "the skyrocketing cost of health care is putting everyone in a much more chatty and cooperative mood" about overhauling the U.S. health care system.

11 Jun 2008

Bush Administration requests $275 million increase for FDA in FY 2009 budget

The Bush Administration on Monday requested that Congress allocate an additional $275 million in fiscal year 2009 for FDA, the New York Times reports. The funds would be used to improve drug and food safety in the U.S. (Harris, New York Times, 6/10).

11 Jun 2008

Health Care News and Research

Collaborative effort by FDA and EMEA expected to yield additional safety data when assessing new drugs

UT Southwestern investigators test groundbreaking depression research in real-world setting

Rural, unmarried women at higher risk for depression

Australian Government oddly excludes AMA again on health plans - AMA negative about plans to ease GP shortage

Advanced cancer patients often unaware of life expectancies, effects of chemotherapy, according to perspective

Obama, McCain discuss health care proposals

CMS to launch Medicare pilot project that will provide physicians with incentives to use health IT

Bill should be passed allowing terminally ill access to experimental drugs, journal op-ed states

Massachusetts insurers to expand health plans with physician ranking system despite lawsuit

Colorado SCHIP classified 10% of beneficiaries incorrectly, according to state auditors

House bill would allow small businesses to form statewide, nationwide pools for purchasing insurance

U.N. Secretary-General calls for end of discrimination against, travel restrictions on people living with HIV/AIDS

Public health agencies call on G8 leaders to allocate increased resources to health programs worldwide

FDA advisory panel voices concern over risks of HIV vaccine trials in teenagers

UNAIDS Executive Director Piot to step down

Specific immune therapy works for many people with allergies

Children in non-English-speaking households experience multiple health disparities

Government and nurses call for a major shake-up of Australia's health system

The Politico examines prospects for U.S. health care system overhaul

Bush Administration requests $275 million increase for FDA in FY 2009 budget

Event guide: 3rd Measuring Patient Engagement Summit eBook

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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