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Specialty News

October 23, 2017
October 23, 2017
Final results from the Phase III KEYNOTE-006 clinical trial uphold interim analyses that demonstrated pembrolizumab as a superior treatment for...
Final results from the Phase III KEYNOTE-006 clinical trial uphold interim analyses that demonstrated pembrolizumab as a superior treatment for advanced melanoma compared with ipilimumab. With patient participation in 16 countries, study recruitment and randomization took place September 18, 2013–March 3, 2014.
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October 20, 2017
October 20, 2017
Imprimis Pharmaceuticals announced Thursday it plans to introduce a less expensive alternative to cyclosporine (Restasis—Allergan). According to...
Imprimis Pharmaceuticals announced Thursday it plans to introduce a less expensive alternative to cyclosporine (Restasis—Allergan). According to Imprimis CEO Mark Baum, the therapy will cost $0.99 for a 1-month supply, with refills starting at $79 a month.
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October 10, 2017
October 10, 2017
Bevacizumab won FDA approval for treatment of advanced cervical cancer based on preliminary trial evidence and now, 3 years later, final analysis of...
Bevacizumab won FDA approval for treatment of advanced cervical cancer based on preliminary trial evidence and now, 3 years later, final analysis of the study results has been completed. The Phase III investigation, which opened enrollment in early 2009, randomized participants into one of four arms: I.V.
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October 01, 2017
October 07, 2017
Specialty pharmacists must understand the phenomenon of “dose creep”—increasing the dose of drug administered or reducing the intervals between...
Specialty pharmacists must understand the phenomenon of “dose creep”—increasing the dose of drug administered or reducing the intervals between administration—not only to take care of our patients but also to help manage overall resources in our complex health care system.
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September 29, 2017
September 29, 2017
FDA approved on September 28 abemaciclib (Verzenio—Eli Lilly) for the treatment of adults who have hormone receptor (HR)-positive, human epidermal...
FDA approved on September 28 abemaciclib (Verzenio—Eli Lilly) for the treatment of adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy.
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September 25, 2017
September 25, 2017
Phase III testing targeted ataluren—which stimulates production of dystrophin protein—as a treatment for Duchenne muscular dystrophy (DMD), which is...
Phase III testing targeted ataluren—which stimulates production of dystrophin protein—as a treatment for Duchenne muscular dystrophy (DMD), which is caused by inadequate stores of the protein.
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September 25, 2017
September 25, 2017
Express Scripts has criticized the $475,000 price tag on Novartis AG's latest breakthrough cancer therapy. The cost of the leukemia treatment—...
Express Scripts has criticized the $475,000 price tag on Novartis AG's latest breakthrough cancer therapy.
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September 22, 2017
September 22, 2017
FDA on Thursday offered new draft guidance on statistical approaches recommended for evaluating analytical similarity for biosimilars and functional...
FDA on Thursday offered new draft guidance on statistical approaches recommended for evaluating analytical similarity for biosimilars and functional attributes of the reference product.
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September 22, 2017
September 22, 2017
FDA warned Thursday that obeticholic acid (Ocaliva—Intercept Pharmaceuticals) is being incorrectly dosed in some patients with moderate-to-severe...
FDA warned Thursday that obeticholic acid (Ocaliva—Intercept Pharmaceuticals) is being incorrectly dosed in some patients with moderate-to-severe decreases in liver function, and that is leading to a higher risk of serious liver injury and death.
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September 13, 2017
September 13, 2017
Cyltezo
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