FDA follow-up confirms low risk of long-term vision loss secondary to ezogabine pigment changes
June 16th 2015FDA has issued a drug safety communication on GlaxoSmithKline's anti-seizure drug ezogabine (Potiga). Side effects of the the drug, which may include vision loss due to eye pigment change and skip discoloration, can be "adequately managed" by following the label, reports the FDA.
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Ibrutinib interim data promising in patients with chronic graft-versus-host-disease
June 11th 2015Ibrutinib may be a safe and potentially effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were refractory to steroid treatment or steroid-dependent, suggested interim data presented at the 51st American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
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FDA's Sentinel Initiative identifies drug safety problems
June 9th 2015The FDA's Sentinel Initiative uses big data and broad networks to detect and respond to risks associated with prescription drugs. In the June 4th Health Affairs' Health Policy Brief, the FDA describes how the Sentinel Initiative improves on the FDA's Adverse Event Reporting System (FAERS) database.
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FDA panel recommends approving Repatha, Praluent to lower cholesterol
June 9th 2015FDA’ s Endocrinologic and Metabolic Drugs Advisory Committee recommended this week to approve cholesterol-lowering drug evolocumab (Repatha) from Amgen in a 15-0 vote. It also voted 13-3 in favor of FDA approving Sanofi and Regeneron's Praluent (alirocumab), but most panel members called for a restricted label in high-risk patients with genetic conditions causing elevated cholesterol, rather than wider use in the general elevated cholesterol population.
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7 proven elements of a successful antibiotic stewardship program
June 9th 2015Earlier this year, the Obama Administration announced a 5-year plan to combat antibiotic resistance. The Forum on Antibiotic Stewardship was created to meet this "growing public health threat" and to reduce the misuse of antibiotics.
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Combo therapy yields intriguing results in melanoma progression
June 5th 2015Results of a new study on combination drugs used to treat melanoma were presented at the 2015 American Society of Clinical Oncology meeting in Chicago. Researchers showed that a combination of ipilimumab and nivolumab stopped the advancement of melanoma for nearly a year in 58% of cases.
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Continued advances in cancer outcomes unveiled at ASCO
June 4th 2015Leading cancer drugs reduced the risk of death by half for people with lung cancer and assisted patients with HER2-positive breast cancer live longer without the disease recurring. The findings were just two of the numerous important study results presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago, Ill., this week.
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