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FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has notified the Company that it is extending the Prescription Drug User Fee Act goal date for the Company's supplemental biologics license application for XIAFLEX (collagenase clostridium histolyticum) for the treatment of Peyronie's disease from September 6, 2013 to December 6, 2013.

28 Aug 2013

State Highlights: N.H. pushes back at health care costs ahead of Obamacare

Health care spending has increased faster and reached higher levels in New Hampshire than in most other states, but hospitals, insurers and others have been trying to tackle the problem long before the Affordable Care Act. The New Hampshire Citizens Health Initiative, which promotes affordable, effective and accessible health care, has overseen several of the largest efforts, including a medical home pilot project in 2011 and an accountable care organization model (8/26).

28 Aug 2013

FDA grants Priority Review designation to sNDA for Nexavar tablets

Bayer HealthCare and Onyx Pharmaceuticals today announced that the U.S. Food and Drug Administration has granted Priority Review designation to the supplemental New Drug Application for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets under evaluation for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.

27 Aug 2013

State highlights: Colo. effort to reduce hospital readmissions pays off

A 2-year-old initiative between the Colorado Hospital Association and UnitedHealthcare to reduce costly unnecessary readmissions is reporting major gains on a lingering problem. The readmission rate for "same cause" patients -- those coming back for the same malady as their initial visit -- dropped to just over 5 percent from 9.8 percent the year before, at 19 Colorado hospitals, according to a release by the collaboration (Booth, 8/21).

26 Aug 2013

UCLA-led study points to simple solution that could save Medicare dollars for patients

As everyone knows, medications are expensive, and even with insurance coverage, patients' out-of-pocket drug costs can be quite hefty. This holds true for individuals with Medicare Part D, also known as the prescription drug benefit, which subsidizes the cost of medications for about 28 million Medicare beneficiaries.

23 Aug 2013

Report shows nonmedical use of pain relievers may increase risk of using heroin later

A new report by the Substance Abuse and Mental Health Services Administration (SAMHSA) shows that people aged 12 to 49 who had used prescription pain relievers nonmedically were 19 times more likely to have initiated heroin use recently (within the past 12 months of being interviewed) than others in that age group (0.39 percent versus 0.02 percent).

23 Aug 2013

Viewpoints: Medicare's lessons for the health law; Krauthammer says Obama shouldn't try to write his own laws

As a Sept. 30 budget deadline approaches, many in the Republican Party are pushing to repeal the Affordable Care Act, better known as Obamacare. The law's most radical opponents are even threatening to shut down the government by refusing to pass a continuing resolution, which would fund existing government programs at current or slightly adjusted levels.

17 Aug 2013

Calif. lawmakers advance nurse practitioner, pharmacist scope-of-practice bills

The legislation will likely rally opposition over care quality concerns, even as the nurse bill loses a key supporter.

16 Aug 2013

Longer looks: Fight against meth labs faces drug makers' opposition

Every week reporter Ankita Rao selects interesting reading from around the Web.

16 Aug 2013

CVS Caremark net revenues increase 1.7% in Q2 2013

CVS Caremark Corporation today announced operating results for the three months ended June 30, 2013.

6 Aug 2013

Medicare premiums hold the line -- increasing $1 in price from the past three years

The Obama administration cast the average monthly premium price increase as a matter of inches.

1 Aug 2013

First Edition: July 31, 2013

Today's headlines include reports that Medicare premiums will remain stable in 2014 and coverage of a new Congressional Budget Office estimate regarding the cost of delaying the health law's employer mandate.

31 Jul 2013

Obama administration touts slower health care cost increases

According to USA Today, personal health care costs rose at the slowest rate in the last 50 years, based on statistics for the past year ending in May.

31 Jul 2013

FDA acknowledges receipt of NDA resubmission of dapagliflozin drug for treatment of type 2 diabetes

AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes.

26 Jul 2013

Viewpoints: It's time for Congress to talk about 'death panels;' Will health law opponents help constituents get coverage?

Probably nothing causes members of Congress more unease than having to talk about death. It's only been four years since healthcare reform became more about whether President Obama wanted to throw mama from a train via "death panels" than, well, how best to reform a broken healthcare system. Still, there are several representatives from both parties who want to discuss it (Daniel Rothberg, 7/22).

24 Jul 2013

GW Pharmaceuticals to expand marketing authorization for Sativex to France

GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that it has submitted an application under the European Mutual Recognition Procedure seeking to expand the marketing authorization for Sativex into France for the treatment of spasticity due to Multiple Sclerosis.

22 Jul 2013

House panel releases draft bill to repeal Medicare's payment system for doctors

The proposal would get rid of the sustainable growth rate formula and replace it with a system that rewards doctors based on quality and efficiency measures, MedPage Today reports.

20 Jul 2013

FDA grants orphan drug designation to ARMAGEN's AGT-182 for treatment of Hunter syndrome

ARMAGEN announced today that the U.S. Food and Drug Administration has granted orphan drug designation to its lead product AGT-182 for the treatment of mucopolysaccharidosis type II (also known as Hunter syndrome or MPS II).

19 Jul 2013

Viewpoints: Disability insurance 'time bomb;' Leavitt on the lessons of Medicare Part D's rollout; Boys and eating disorders

Social Security for retirement and Medicare are the best known of the major entitlement programs with looming financial disasters. While some argue about when they will run out of money, their projected 75-year unfunded liabilities grow larger every year and now total $40 trillion, much worse thereafter. But the ticking time bomb of entitlement reform is Social Security's Disability Insurance Fund (Michael J. Boskin, 7/14).

16 Jul 2013

Drexel University receives NIH grant to study medical marijuana use among LA young adults

Drexel University has received a grant for a five-year study of medical marijuana and its impact on drug use and physical and psychological health among young adults in Los Angeles. It is the first large-scale NIH project funded to directly investigate medical marijuana use among young adults aged 18 to 26.

15 Jul 2013