FDA approves first drug to treat patients with a chronic type of bone marrow disease
December 9th 2014FDA approved a new use for ruxolitinib (Jakafi, Incyte) to treat patients with polycythemia vera (PV), a chronic type of bone marrow disease. Jakafi is the first drug approved by FDA for this condition.
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CMS’ new rules will deny enrollment to “bad apple” providers
December 9th 2014Providers, owners and suppliers who owe Medicare money, have been convicted of felonies or have a history of billing abuse will be excluded from enrollment under new rules adopted by the Centers for Medicare and Medicaid Services (CMS).
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FDA panel recommends Actavis' antibiotic for approval
December 8th 2014Actavis Plc has announced that the Infective Drugs Advisory Committee, which makes recommendations to the FDA concerning the safety and effectiveness of drug products for use in the treatment of infectious diseases, has voted to recommend approval of its New Drug Application for ceftazidime-avibactam.
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In patients with opioid dependence, buprenorphine and naloxone (Zubsolv, Orexo) sublingual tablet (CIII) demonstrated comparable patient retention in treatment at days 3 and 15 versus generic buprenorphine and Suboxone film respectively, according to data presented at the 25th Annual Meeting and Symposium of the American Academy of Addiction Psychiatry (AAAP) in Aventura, Fla.
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This year, the American Heart Association (AHA) Scientific Sessions were held in Chicago, Illinois, from November 15 to 19. Of all of the late-breaking clinical trials presented at AHA 2014, the IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) study of Merck’s low-density lipoprotein cholesterol (LDL-C)-reducing drugs-the statin, Zocor (simvastatin), and the fixed-dose combination, Vytorin (ezetimibe/simvastatin)-stole the show.
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FDA grants breakthrough status to investigational, oral proteasome inhibitor for AL amyloidosis
December 4th 2014Investigational, oral proteasome inhibitor, ixazomib (MLN9708, Takeda) has FDA has granted breakthrough therapy status for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. This is the first proteasome inhibitor and first investigational therapy for AL amyloidosis to receive breakthrough therapy designation.
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ACA initiatives lead to decline in patient deaths and save $12 billion
December 4th 2014An estimated 50,000 fewer patients died in hospitals and approximately $12 billion was saved between 2010 and 2013 because of reduced hospital-acquired conditions,according to the U.S. Department of Health and Human Services (HHS).
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Health expenditures slow to lowest growth rate in 53 years
December 4th 2014Total national health spending slowed from 4.1% in 2012 to 3.6% in 2013, the slowest rate of growth since it was first tracked in 1960, according to a report from the Office of the Actuary (OACT) at the Centers for Medicare and Medicaid Services (CMS).
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Express Scripts may switch hepatitis C drugs on preferred formulary
December 2nd 2014While pharmaceutical manufacturer AbbVie’s new hepatitis C drug has not yet been approved by FDA, pharmacy benefits manager Express Scripts has expressed interest in switching to the drug in its preferred drug formulary.
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NIH reports first experimental Ebola vaccine produces immune response
December 2nd 2014The first experimental Ebola vaccine has been shown to be safe and prompt an immune response in results from a National Institutes of Health (NIH) phase 1 clinical trial. The vaccine produced immune system responses and was well tolerated in the whole study cohort of 20 healthy adults.
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FDA approves Priftin tablets to treat latent tuberculosis infection
December 2nd 2014Following a priority review designation, FDA has approved rifapentine (Priftin, Sanofi) in combination with isoniazid (INH) for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients aged 2 years and older at high risk of progression to tuberculosis (TB) disease.
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AHA: Rivaroxaban linked to fewer hospitalization days compared to warfarin in NVAF patients
December 1st 2014Once-daily rivaroxaban (Xartelto, Janssen) is associated with significantly fewer hospitalization days and outpatient visits compared to warfarin in patients with nonvalvular atrial fibrillation (NVAF), according to data presented at the American Heart Association (AHA) 2014 Scientific Sessions in Chicago.
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