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FDA accepts MAP Pharmaceuticals' LEVADEX NDA for filing

MAP Pharmaceuticals, Inc. today announced that its New Drug Application (NDA) for LEVADEX® orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA), with a goal date of March 26, 2012 under the Prescription Drug User Fee Act (PDUFA).

2 Aug 2011

SXC to launch enhanced Coordination of Benefits service in the state Medicaid market

SXC Health Solutions Corp., a leading provider of technology and pharmacy benefit management services, is launching the industry's first automated, enhanced Coordination of Benefits service in the State Fee-For-Service Medicaid market.

1 Aug 2011

AHRQ: Average annual prescription drug expenses for children with asthma have doubled

The percentage of American children treated for asthma increased while their annual drug expenses more than doubled over a 10-year period, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

30 Jul 2011

Research roundup: Avoiding readmissions; the future of ACOs

Every week, Kaiser Health News reporter Shefali S. Kulkarni compiles a selection of recently released health policy studies and briefs.

30 Jul 2011

Pew director issues statement on Prescription Drug User Fee Act hearing

Allan Coukell, director of medical programs for the Pew Health Group, issued the following statement today on a U.S. Senate Health, Education, Labor & Pensions Committee hearing, "FDA User Fees: Advancing Public Health."

29 Jul 2011

Viewpoints: Pessimism on partisan debt dealings; supporting community clinics; 'mystery shopper' should go forward

FDR began the entitlement era with the New Deal and Social Security, but for decades it remained relatively limited. … That changed in the mid-1960s with LBJ's Great Society and the dawn of the health-care state. Medicare and Medicaid were launched in 1965 with fairy tale estimates of future costs. Medicare, the program for the elderly, was supposed to cost $12 billion by 1990 but instead spent $110 billion.

29 Jul 2011

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

28 Jul 2011

Medicare Part D ups patient compliance, reduces hospital costs

The findings, which were published today in the Journal of the American Medical Association, suggested that for seniors, access to affordable prescription drugs would reduce their need for emergency and short-term nursing care.

28 Jul 2011

PCMA President releases statement on new Medicare Part D study

Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt released the following statement today on a new study published in the Journal of the American Medical Association that found "implementation of Medicare Part D was followed by a significant reductions in nondrug medical spending, particularly on acute and post acute care, for elderly Medicare beneficiaries with limited prior drug coverage".

28 Jul 2011

Dr. Reddy's, FUJIFILM sign MoU to enter partnership in the generic drugs business

FUJIFILM Corporation President and CEO, Shigetaka Komori and Dr. Reddy's Laboratories Ltd. Vice-Chairman and CEO, G V Prasad today signed a Memorandum of Understanding to enter into an exclusive partnership in the generic drugs business for the Japanese market and to establish a joint venture in Japan.

28 Jul 2011

Viewpoints: Chambliss on reviving Gang of Six proposal; WSJ on Medicare Part D; Friedman on 'doing this right'

I joined five other senators to identify the difficult issues and make the hard, necessary decisions to address the twin challenges of our deficit and debt. ... Among other provisions, our proposal reduces the debt by $3.7 trillion over the next 10 years, stabilizes our publicly held debt by 2014, and imposes tough and honest budget enforcement.

28 Jul 2011

Britain’s prescription drug use statistics revealed

According to latest NHS figures number of prescriptions dispensed has soared by 70 per cent over the last decade. Every man, woman and child in the country received on average 17.8 prescription items in 2010. The vast majority went to those aged over 60, who received 42.4 items each in 2007.

27 Jul 2011

Surge of generics will trigger drop in drug prices

In the next 14 months, seven of the world's 20 best-selling drugs are scheduled to go "off patent." As they do, the brand-name drugs will lose out to generic versions, cutting costs for patients and companies that provide health benefits.

27 Jul 2011

Report: Seniors still struggle with drug costs

Five years after the launch of Medicare prescription drug coverage, many beneficiaries are still struggling to sign up, according to a new report from the Medicare Rights Center.

27 Jul 2011

Study explores factors for misuse of prescription opioid in young injection drug users

A new study by researchers at Drexel University's School of Public Health suggests that abuse of prescription painkillers may be an important gateway to the use of injected drugs such as heroin, among people with a history of using both types of drugs.

25 Jul 2011

Medicare Part D prescription drug rebates would increase monthly premiums for seniors

Including Medicare Part D prescription drug rebates in the final debt ceiling package would increase monthly premiums by up to about 40 percent for more than 17 million seniors, according to a new analysis of government data.

22 Jul 2011

Purdue Pharma develops new online resource for combating prescription drug abuse

A new online resource, RxSafetyMatters.org, is now available to help healthcare professionals, law enforcement, and community organizations combat the illegal diversion and abuse of prescription medications.

20 Jul 2011

Investigational compound dapagliflozin receives negative recommendation from FDA Advisory Committee

Bristol-Myers Squibb Company and AstraZeneca today reported the outcome of the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin.

20 Jul 2011

FDA ODAC recommends approval of Seattle Genetics' ADCETRIS for Hodgkin lymphoma after ASCT

Seattle Genetics, Inc. today announced that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS™ (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant (ASCT).

15 Jul 2011

Viewpoints: Prominent Republicans against IPAB; docs defend health law; medical marijuana research

The IPAB has created "immediate uncertainty at hand," says Scott & White Healthcare in central Texas, for their 12 hospitals and more than 800 physicians. Many more organizations and associations have expressed similar concerns and urged me to do what I can to repeal this ill-conceived bureaucratic board. That's why I have introduced the Health Care Bureaucrats Elimination Act, and why I'm testifying Wednesday on the other side of the Capitol to build support in the House.

14 Jul 2011

Prescription Drug News and Research

FDA accepts MAP Pharmaceuticals' LEVADEX NDA for filing

SXC to launch enhanced Coordination of Benefits service in the state Medicaid market

AHRQ: Average annual prescription drug expenses for children with asthma have doubled

Research roundup: Avoiding readmissions; the future of ACOs

Pew director issues statement on Prescription Drug User Fee Act hearing

Viewpoints: Pessimism on partisan debt dealings; supporting community clinics; 'mystery shopper' should go forward

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Medicare Part D ups patient compliance, reduces hospital costs

PCMA President releases statement on new Medicare Part D study

Dr. Reddy's, FUJIFILM sign MoU to enter partnership in the generic drugs business

Viewpoints: Chambliss on reviving Gang of Six proposal; WSJ on Medicare Part D; Friedman on 'doing this right'

Britain’s prescription drug use statistics revealed

Surge of generics will trigger drop in drug prices

Report: Seniors still struggle with drug costs

Study explores factors for misuse of prescription opioid in young injection drug users

Medicare Part D prescription drug rebates would increase monthly premiums for seniors

Purdue Pharma develops new online resource for combating prescription drug abuse

Investigational compound dapagliflozin receives negative recommendation from FDA Advisory Committee

FDA ODAC recommends approval of Seattle Genetics' ADCETRIS for Hodgkin lymphoma after ASCT

Viewpoints: Prominent Republicans against IPAB; docs defend health law; medical marijuana research

Industry Focus eBook - Cell & Gene Therapy (1st Edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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