FDA has approved a new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
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Ledipasvir-sofosbuvir combination achieves 90% cure rate for HCV patients without cirrhosis
April 17th 2014An 8-week regimen of ledipasvir-sofosbuvir was highly effective (>90% cure) in non-cirrhotic HCV patients with genotype infection, and adding ribavirin or extending treatment to 12 weeks did not significantly improve the results, according to a study published in the New England Journal of Medicine.
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Payers seek new strategies in coordinating costs, management of specialty drugs
April 17th 2014As specialty drugs become the standard of care for many complex diseases, they present unique challenges to payers, according to the 10th edition of the EMD Serono Specialty Digest. Specialty drugs can be delivered through various routes of administration (subcutaneous injection, intravenous, intramuscular injection, oral), all of which may have unique coverage criteria, patient cost share, clinical management, and patient access.
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Timothy Grass Pollen Allergen Extract approved by FDA
April 16th 2014FDA has approved the Timothy Grass Pollen Allergen Extract (Grastek, Merck) sublingual tablet as immunotherapy to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in children as young as 5 years of age and adults up to the age of 65. The tablet is a new option for patients who decline allergy shots.
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National, state data show ongoing efforts needed help fight healthcare-associated infections
April 11th 2014Progress has been made in the effort to eliminate infections that commonly threaten hospital patients, but more work is needed to improve patient safety, according to 2 reports released by the Centers for Disease Control and Prevention (CDC).
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Telephonic MTM can benefit lower risk Medicare patients after hospital discharge
April 11th 2014Low-risk Medicare patients entering home healthcare and receiving a telephonic medication therapy management (MTM) consultation by a pharmacist were three times less likely to be hospitalized within the next 2 months, while those at greater risk saw no benefit, according to a study in Health Services Research.
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Drugs in Perspective: Farxiga (dapagliflozin)
April 11th 2014Antidiabetic drugs are considered to be first-line treatment options for individuals with type 1 and type 2 diabetes mellitus. It is estimated that type 2 diabetes affects about 24 million persons in the United States. Over time high blood levels can lead to complications such as heart disease, kidney damage, or blindness.1 When it comes to the treatment of type 2 diabetes individuals have the option of using oral hypoglycemic agents, compared to individuals with type 1 diabetes that requires insulin therapy.
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FDA approves first naloxone treatment to be given by caregivers to reverse opioid overdose
April 10th 2014FDA has approved naloxone hydrochloride injection (Evzio; Kaléo, formerly Intelliject) for emergency treatment when opioid overdose is known or suspected because of respiratory and/or central nervous system depression.
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FDA approves Pradaxa for treatment, reduction in risk of recurrence of DVT, PE
April 9th 2014FDA approved dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals) for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
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USPSTF: Some pregnant women should take low-dose aspirin to prevent pre-eclampsia
April 9th 2014The U.S. Preventive Services Task Force (USPSTF) found that pregnant women who are at high risk for developing pre-eclampsia can take a low dosage of aspirin daily to help prevent the condition, and this can result in better health outcomes for both the mother and the baby.
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Increased risk of psychiatric diagnoses seen following ICU admission
April 8th 2014Critically ill patients requiring mechanical ventilation in an intensive care unit (ICU) may be at increased risk of a new psychiatric illness and medication use following hospital release, according to a report published March 19 in JAMA.
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AMCP: Generic availability more important than patent expiration
April 5th 2014In yesterday’s pipeline update, Chris Peterson, PharmD, a director in the Emerging Therapeutics department at Express Scripts, reviewed the trend in FDA approvals and noted several of the key therapeutic areas with recent generics.
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