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FDA invites Amgen for ODAC meeting on XGEVA sBLA to treat castration-resistant prostate cancer

Amgen today announced the U.S. Food and Drug Administration has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

30 Dec 2011

Powerful painkiller on its way to the market: Experts worry about addiction woes

Drug makers are on their way to a pure, more powerful version of the nation’s second most-abused medicine, which has addiction experts worried that it could spur a new wave of abuse. The new pills contain the highly addictive painkiller hydrocodone, packing up to 10 times the amount of the drug as existing medications such as Vicodin.

28 Dec 2011

FDA accepts Gilead's Quad HIV regimen NDA for review

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.

26 Dec 2011

Viewpoints: Picking the 'right fights'; Sebelius's 'special place' in history

Republicans do need to fight for their priorities, but it helps to pick the right fights. They should return in 2012 ready to make their differences clear on taxes, health care, regulation, and how to grow an economy (12/23).

23 Dec 2011

Viewpoints: Republicans' 'gift' to Obama; Essential benefits rule a 'lump of coal'

One photo snapped Wednesday on Capitol Hill captured the essence of Congress in 2011. It showed a group of senior House Republicans sitting on one side of a long table, waiting for their Senate counterparts to show up for a negotiating session the House had demanded. ... What viewers should really have seen in the photo was the Republican leadership team whose miscalculations may soon cause payroll taxes to go up -; and unemployment benefits to be truncated, and payment rates to Medicare doctors slashed. That's on the verge of happening.

23 Dec 2011

Health care issues leaving mark on presidential race

President Obama is busy touting his health law, while Mitt Romney argues that an individual mandate in Massachusetts is a "conservative" idea. In the meantime, the Associated Press examines Newt Gingrich's past support of the Children's Health Insurance Program.

23 Dec 2011

First Edition: December 22, 2011

Today's early morning highlights from the major news organizations, including articles on the Capitol Hill stalemate that threatens to cut Medicare payments to doctors and government efforts to keep details of a research experiment on bird flu secret.

22 Dec 2011

Despite improvements, disparities in diagnosis and treatment of depression remain

Despite improvements to diagnostic tools and therapies in the two last decades, significant disparities in the diagnosis and treatment of depression remain, according to Rutgers research published online by the American Journal of Public Health; print, February 2012.

21 Dec 2011

FDA accepts Pfizer's tofacitinib NDA for review

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

21 Dec 2011

State roundup: Florida awaits Medicaid waiver news

Now, nurses regularly do everything from give insulin shots to empty urinary catheter bags. At the same time, state budget cuts mean the number of school nurses in California is shrinking. As a result, nurses say, they are responsible for more students every year and are largely consumed with keeping "medically fragile" children in class.

16 Dec 2011

Almost two-thirds of pregnant women in B.C. consume prescription drugs

Almost two-thirds of women in British Columbia filled at least one prescription at some point in their pregnancy, including drugs with potential risks, according to a new study by University of British Columbia researchers.

16 Dec 2011

FDA accepts Vertex KALYDECO NDA for six-month Priority Review

Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KALYDECOTM (ivacaftor) and granted the company's request for six-month Priority Review.

16 Dec 2011

MTF survey shows large decline in teen smoking

Cigarette and alcohol use by eighth, 10th and 12th-graders are at their lowest point since the Monitoring the Future (MTF) survey began polling teenagers in 1975, according to this year's survey results. However, this positive news is tempered by a slowing rate of decline in teen smoking as well as continued high rates of abuse of other tobacco products, marijuana and prescription drugs.

15 Dec 2011

With federal court action looming, Sebelius says Plan B decision 'not about politics'

A federal judge in Brooklyn will hear arguments Tuesday afternoon on the constitutionality of the federal decision regarding the access teenage girls should have to morning-after contraceptive pills. Meanwhile, Health and Human Services Secretary Kathleen Sebelius said the decision about Plan B's over-the-counter status was not a political one.

14 Dec 2011

Onyx receives FDA Standard Review designation for carfilzomib NDA to treat RRMM

Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Standard Review designation to the New Drug Application (NDA) for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma.

12 Dec 2011

State roundup: Consumers dispute Iowa rate hike; Wis. senior program extension?; Fla. criticized on nursing homes

California Pacific Medical Center, including its St. Luke's campus, is San Francisco's most profitable hospital, yet it spends proportionately far less on care for poor residents than other private nonprofit hospitals in the city, according to a new report.

9 Dec 2011

Research roundup: Depression and Medicaid spending; Saving on chronic care costs?: Mental health coverage

The researchers looked at treatment of depression in Medicaid enrollees in Florida from 1996-2006. They found a 29 percent increase in spending "despite decreases in inpatient costs." They attributed much of the increase to the growing use of antipsychotic drugs. They concluded that "spending for Medicaid enrollees with depression increased substantially, with minimal improvements in quality of care".

9 Dec 2011

Dramatic rise in substance abuse treatment admission rates from 1999-2009

A new report shows that while the overall rate of substance abuse treatment admissions among those aged 12 and older in the United States has remained nearly the same from 1999 to 2009, there has been a dramatic rise (430 percent) in the rate of treatment admissions for the abuse of prescription pain relievers during this period.

9 Dec 2011

Pharmaceutical spam leads patients to seek out online information about prescription drugs

Spam advertising of pharmaceutical products is leading patients to seek out information about prescription drugs online, according to a report to be published in the International Journal Business and Systems Research. If those drugs are not available to the internet user through their physician there is a risk that they may obtain such products via illicit means.

9 Dec 2011

FDA advisory panel OKs anemia drug peginesatide

Once approved by the FDA, the once-monthly injection could capture a share of the $3 billion U.S. market for anemia drugs used for kidney dialysis patients, currently dominated by Amgen Inc's blockbuster Epogen. Affymax, which developed the drug with partner Takeda Pharmaceutical Co Ltd, is also expected to price its product below Epogen.

8 Dec 2011

Prescription Drug News and Research

FDA invites Amgen for ODAC meeting on XGEVA sBLA to treat castration-resistant prostate cancer

Powerful painkiller on its way to the market: Experts worry about addiction woes

FDA accepts Gilead's Quad HIV regimen NDA for review

Viewpoints: Picking the 'right fights'; Sebelius's 'special place' in history

Viewpoints: Republicans' 'gift' to Obama; Essential benefits rule a 'lump of coal'

Health care issues leaving mark on presidential race

First Edition: December 22, 2011

Despite improvements, disparities in diagnosis and treatment of depression remain

FDA accepts Pfizer's tofacitinib NDA for review

State roundup: Florida awaits Medicaid waiver news

Almost two-thirds of pregnant women in B.C. consume prescription drugs

FDA accepts Vertex KALYDECO NDA for six-month Priority Review

MTF survey shows large decline in teen smoking

With federal court action looming, Sebelius says Plan B decision 'not about politics'

Onyx receives FDA Standard Review designation for carfilzomib NDA to treat RRMM

State roundup: Consumers dispute Iowa rate hike; Wis. senior program extension?; Fla. criticized on nursing homes

Research roundup: Depression and Medicaid spending; Saving on chronic care costs?: Mental health coverage

Dramatic rise in substance abuse treatment admission rates from 1999-2009

Pharmaceutical spam leads patients to seek out online information about prescription drugs

FDA advisory panel OKs anemia drug peginesatide

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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