Prescription Drug News and Research

RSS

Nuvo Research, NovaMedica enter into agreement to market Pennsaid products in Russia

Nuvo Research Inc., a specialty pharmaceutical company with a diverse portfolio of products in the areas of topical pain and immunology, and NovaMedica LLC, a Russian pharmaceutical company, today announced that they have signed a supply and distribution agreement providing NovaMedica the exclusive rights to market and sell Nuvo's Pennsaid 1.5% and Pennsaid 2% products in Russia and some of the Community of Independent States.

19 Dec 2013

FDA accepts Regeneron's EYLEA Injection sBLA for standard review

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted for standard review the Company's supplemental Biologics License Application for EYLEA (aflibercept) Injection for the treatment of Diabetic Macular Edema.

18 Dec 2013

Prescription drug misuse and driving after using drugs on the rise among Ontario students

Alcohol consumption and smoking among Ontario students in grades 7-12 is at an all-time low; however recreational use of over-the-counter drugs is on the rise. Prescription drug misuse and driving after using drugs also remain elevated according to the 2013 Ontario Student Drug Use and Health Survey released by the Centre for Addiction and Mental Health.

16 Dec 2013

New test may help decrease risk of suicidality in patients treated with antidepressants

The new test, based on research carried out at the Max Planck Institute of Psychiatry, should help doctors to decrease the risk of suicidality in patients treated with antidepressants who show certain gene markers. Sundance is completing a new round of funding to extend the initial validation results reported by the Institute. The company plans to launch the test immediately as a laboratory developed test. In addition, clinical studies in support of a U.S. Food and Drug Administration submission for market clearance, CE marking and reimbursement will be initiated. Sundance expects to submit its application to the agencies within 18 months.

13 Dec 2013

State highlights: States scramble to change newborn screening programs; obesity rate flat; New York hospital charges vary considerably

States across the country are making significant changes to their newborn screening programs after a Milwaukee Journal Sentinel investigation found that thousands of hospitals were sending babies' blood samples late to state labs that test for rare yet deadly genetic disorders. From keeping labs open on weekends to identifying problem hospitals and providing them with regular performance reports, dozens of health officials are reviewing and retooling their state-run programs (Gabler, 12/11).

13 Dec 2013

FDA Advisory Committee recommends metreleptin for treatment of generalized lipodystrophy

AstraZeneca and Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommends the investigational medicine metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy (LD).

12 Dec 2013

GW Pharmaceuticals receives U.S. patent for treating glioma

GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 12/996,124, a patent which covers the use of cannabinoids for treating glioma.

11 Dec 2013

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.