FDA green lights combination antibiotic
December 22nd 2014FDA approved ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals, Inc.) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria.
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FDA approves Viekira Pak to treat hepatitis C
December 19th 2014FDA has approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
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FDA approves first therapy for treating patients with GEP-NETs
December 18th 2014FDA has approved lanreotide (Somatuline Depot, Ipsen) Injection, 120 mg (referred to as Somatuline) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
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Novel new drugs approved in 2014
December 17th 2014FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).
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HHS partners with 7-11 Inc. to promote open enrollment
December 16th 2014Customers at 7-11 stores who use a bill-paying system will receive information promoting the Affordable Care Act’s open enrollment period on their printed receipts, allowing HHS to reach financially underserved consumers.
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Naloxone price increases may threaten public safety
December 15th 2014A price increase for a popular form of the medication, naloxone, threatens the ability of non-profit programs and organizations, including police departments around the country, to provide a medical antidote for drug overdoses.
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Humana’s MA accountable care models save money and improve health outcomes
December 15th 2014Medicare Advantage (MA) members in Humana’s accountable care programs in 2013 had 7% fewer emergency room visits and 4% fewer inpatient hospital admissions than members in traditional, fee-for-service settings.
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New vaccine version approved for cancers caused by additional HPV types
December 12th 2014A new vaccine, human papillomavirus (HPV) 9-valent vaccine, recombinant (Gardasil 9, Merck Sharp & Dohme), has been approved by FDA for the prevention of diseases caused by 9 HPV types. It is effective against 5 additional strains of the virus than is the previous FDA-approved version of the vaccine (Gardasil).
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ASH: Data released on largest clinical trial of myelofibrosis patients treated with ruxolitinib
December 12th 2014Data from the largest clinical trial of myelofibrosis patients treated with ruxolitinib (Jakavi, Novartis) support its safety profile and efficacy benefit, as measured in primary and secondary end points, according to a study presented at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco.
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First FDA-licensed test approved for confirming human T-cell lymphotropic virus I/II
December 12th 2014MP Diagnostics HTLV Blot 2.4 (MP Biomedicals) has been approved by FDA as the first FDA-licensed supplemental test for human T-cell lymphotropic virus-I/II (HTLV-I/II). It is a qualitative enzyme immunoassay test, which is to be used to confirm the presence of HTLV antibodies as well as to differentiate between HTLV-I and HTLV-II infection.
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Clinical study to research use of erectile dysfunction drug to treat vascular dementia
December 12th 2014On the 1-year anniversary of the first G8 summit on dementia, new funding has been announced for a study to research the use of tadalafil (Adcirca, Cialis; Eli Lilly), an erectile dysfunction drug, for the treatment of vascular dementia.
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AES: More Rxs for opioid painkillers held by epilepsy patients than by general population
December 11th 2014Formulary managers should be alert to the use of opioid painkillers by special populations, such as people with epilepsy, according to findings during a poster session at the American Epilepsy Society annual meeting in Seattle.
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Post-stroke drug combo linked to lower risk of stroke recurrence
December 10th 2014Dr OvbiageleFor recent ischemic stroke patients, using an optimal combination of evidence-based secondary prevention medication classes, compared to not doing so, was associated with 61% lower odds of experiencing a recurrent stroke, according to a study published online in Neurology.
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