Lenalidomide, Rituximab Combo Granted FDA Approval for Indolent Non-Hodgkin Lymphoma
May 28th 2019The approval of R2 is based on data from the phase 3 AUGMENT study evaluating the safety and efficacy of the combination regimen compared with rituximab plus placebo in patients with previously-treated FL and MZL.
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FDA OKs Lenalidomide, Rituximab Combo for Indolent Non-Hodgkin Lymphoma
May 28th 2019Officials with the FDA today approved lenalidomide (Revlimid, Celgene) in combination with a rituximab product (R2) for the treatment of adult patients with previously-treated follicular lymphoma or marginal zone lymphoma.
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FDA Expands Use of Cariprazine to Include Treatment of Depressive Episodes
May 28th 2019The new indication makes cariprazine (Vraylar, Allergan and Gedeon Richter) the first and only dopamine and serotonin partial agonist to treat the full spectrum of bipolar I symptoms in manic, mixed, and depressive episodes, according to the companies.
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New Therapy for Breast Cancer Granted FDA Approval
May 24th 2019Officials with the FDA have approved alpelisib (Piqray, Novartis) tablets, to be used in combination with the endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
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Recommendations for Counseling Traveling Patients with Diabetes
May 23rd 2019According to the ADA, best practice is to pack at least twice as much medications and glucose testing supplies as normally needed to minimize complications due to travel delays or lost luggage.3 Many manufacturers of insulin pumps will provide a loaner for international travel.
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Drugs of the Future Start with Regulatory Affairs
May 23rd 2019Regulatory affairs is another frontier for pharmacists to explore, and pharmacists are just scratching the surface of the opportunities in this area. In this interview with pharmacist Brendan Doran of CTI Clinical Trial & Consulting, he touches on the many phases of the drug life cycle with an emphasis on the process of bringing a drug to regulatory bodies for market approval, and gives a look into some of the current and emerging roles available in regulatory affairs.
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