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FDA extends initial PDUFA date for Biogen Idec's review of ALPROLIX BLA

Biogen Idec announced today that the U.S. Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for its review of the Biologics License Application (BLA) for ALPROLIX, the company's investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B.

2 Dec 2013

Science Translational Medicine editorial urges researchers to support the Affordable Care Act

An editorial by Harry P. Selker, MD, MSPH, William H. Frist, MD, and Stuart Altman, PhD, published in the November 27 issue of Science Translational Medicine says the Patient Protection and Affordable Care Act is an example of the role of experimentation in improving health at the public policy level.

2 Dec 2013

FDA grants Orphan Drug Designation to CMC Contrast's CMC-001 MRI contrast media

CMC Contrast AB, a privately owned drug development company that is developing a targeted contrast agent for Magnetic Resonance Imaging (MRI), announced today that Orphan Drug Designation has been granted by the US Food and Drug Administration (FDA) for its liver specific contrast agent CMC-001.

27 Nov 2013

QRxPharma refiles MOXDUO New Drug Application with US FDA

QRxPharma Limited announced today that the Company resubmitted its MOXDUO New Drug Application. At a meeting in early October, the United States Food and Drug Administration provided QRxPharma with guidance on its requirements for the NDA refiling as well as data validation documentation.

26 Nov 2013

As popularity of health law 'sinks,' some marketing will wait until new year

In the meantime, a new poll suggests the problems with the health law rollout have harmed the public's view of the law as a whole, and a second poll suggests the public sees addressing health care costs as the central issue.

25 Nov 2013

Expiring patents, austerity measures lead to predictions that prescription drug sales will continue to slow

Growth in global prescription drug spending will slow to the lowest rate in decades as low-cost generic drugs continue replacing former blockbusters in the U.S. and Europe, where governments face new pressure to reduce health care spending, according to a new forecast. The projection from data firm IMS Health shows the global prescription drug market growing by 3 to 6 percent over the next four years to $1.2 trillion by 2017.

21 Nov 2013

First Edition: November 20, 2013

Today's early morning highlights from the major news organizations, including reports that President Barack Obama places some of the blame for the health law's woes with Republicans, and details of comments by an Obama administration tech official that a large portion of the healthcare.gov 'back office' functions are yet to be built.

20 Nov 2013

Obama tells insurers his 'fix' may cost them

President Barack Obama acknowledged to insurance executives that reinstating millions of insurance policies might cost them, according to Politico. Other media outlets report that brokers are worried about their role in the insurance marketplace and how one company is forecasting that a failure to enroll the uninsured could cut prescription drug sales by 30 percent in 2017.

20 Nov 2013

Viewpoints: 'Nation takes stock' of Obama and his health law; Noonan says now is time to hold back Obamacare; Obama needs to be resolute

President Obama has come up with a modest fix for a self-inflicted political wound: his repeated - and wrong - assertions that Americans would be able to keep their health insurance plans if they wanted to under the health care reform law (11/14).

16 Nov 2013

FDA Advisory Committee votes in favor of Vanda's tasimelteon NDA for Non-24-Hour Disorder

Vanda Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee voted overwhelmingly to recommend the approval of Vanda's New Drug Application for tasimelteon, proposed tradename HETLIOZ™, for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.

15 Nov 2013

Viewpoints: Shinseki's efforts haven't yet solved VA's problems; treating children with mental illness is complicated; abuse of painkillers

Just in time for Veterans Day, the embattled secretary of Veterans Affairs, Eric K. Shinseki, announced last week that his department had reduced its backlog of overdue disability claims from more than 600,000 in March to about 400,000. "The trend line is in the right direction," Shinseki told reporters, noting that the VA had cut the number of claims older than a year by 93%. With hundreds of thousands of cases still unresolved, Shinseki hasn't gotten much credit so far - but to the surprise of his critics, he's on track to achieve his goal of eliminating the backlog by 2015. Still, that won't solve all the VA's problems; far from it (Doyle McManus, 11/10).

12 Nov 2013

GW Pharmaceuticals starts Phase 1b/2a clinical trial for Recurrent Glioblastoma Multiforme

GW Pharmaceuticals plc a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced today it has commenced a Phase 1b/2a clinical trial for the treatment of Recurrent Glioblastoma Multiforme.

11 Nov 2013

Research roundup: Pricing and the SHOP exchange; health use in rural vs. urban areas; the health law and AIDS care

Each week, KHN compiles a selection of recently released health policy studies and briefs.

11 Nov 2013

First generic versions of Aciphex delayed-release tablets get FDA approval for GERD treatment

The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease in adults and adolescents (ages 12 and up).

10 Nov 2013

Access to health care increases prescription opioid abuse

Researchers at Indiana University-Purdue University Indianapolis say one way to gauge the extent of prescription opioid pain reliever abuse in any Indiana county is to count the number of health care providers, particularly dentists and pharmacists.

5 Nov 2013

Viewpoints: Website is like 'a patient bleeding from self-inflicted wounds;' remembering patients who never had care and the need for health law

Obamacare is starting to resemble a patient bleeding from self-inflicted wounds. A month after launch, the online health exchanges where individuals are supposed to shop for insurance remain slow or unusable, except in states that opted to run their own marketplaces and did a more competent job than the administration. As if that weren't trouble enough, critics are justifiably mocking President Obama for his repeated, untrue promise that if people liked their health plans, they could keep them. Oops. Hundreds of thousands of people are getting termination notices for plans that don't meet the strict new requirements of the Affordable Care Act. Presumably, not all those people disliked their plans (11/3).

5 Nov 2013

Viewpoints: House Republicans help themselves, and the country, with smart, tough questions to Tavenner; Kentucky senators out of step with eager constituents; replace health law with single payer system

When House Republicans direct their opposition to Obamacare toward aggressive oversight rather than apocalyptic budget shenanigans, they can do themselves and the country a lot of good. That was obvious when the House Ways and Means Committee posed some smart, tough questions about HealthCare.gov to Marilyn Tavenner, who, as the administrator of the Centers for Medicare and Medicaid Services, is perhaps the person most directly responsible for the fiasco. Yes, there were a few "gotcha" questions meant to showcase individual representatives' hatred of the health-care law. But for the most part, the queries seemed designed to find a path toward more competent management of the Patient Protection and Affordable Care Act (10/29).

31 Oct 2013

Health plan cancellations create White House's next set of challenges

News coverage is focusing on the notion that a large percentage of people who currently have individual health coverage are receiving cancellation notices because their plans don't meet the standards created by the health law. Many of these people, according to reports, will face "sticker shock" with their new insurance. A critical emerging question is whether the Obama administration expected this scenario.

30 Oct 2013

New study reveals striking data about misuse of painkillers and sedatives by teens, young adults

With prescription drug abuse at epidemic levels nationwide, and overdoses killing more people than auto accidents in many states, a new University of Michigan study provides striking new data about the misuse of potent prescription painkillers and sedatives by teens and young adults.