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Specialty News

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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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 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 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FDA on Thursday offered new draft guidance on statistical approaches recommended for evaluating analytical similarity for biosimilars and functional...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 13, 2017
September 13, 2017
Cyltezo
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September 13, 2017
September 13, 2017
FDA Commissioner Scott Gottlieb notes that 3 months ago he committed to fully eliminate a backlog of about 200 orphan drug designation requests that...
FDA Commissioner Scott Gottlieb notes that 3 months ago he committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with the agency, and to implement policies that would require FDA to respond to all new designation requests within 90 days of receiving them.
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September 13, 2017
September 13, 2017
Diplomat Pharmacy has agreed to acquire Focus Rx Pharmacy Services, a specialty and infusion pharmacy. "This partnership opens growth opportunities...
Diplomat Pharmacy has agreed to acquire Focus Rx Pharmacy Services, a specialty and infusion pharmacy. "This partnership opens growth opportunities, especially in the key markets of New York and New Jersey," noted Phil Rielly, corporate vice president and president of Diplomat Specialty Infusion Group.
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September 01, 2017
September 06, 2017
FDA has approved delafloxacin (Baxdela—Melinta Therapeutics) to treat acute bacterial skin and skin structure infections (ABSSSI) caused by...
FDA has approved delafloxacin (Baxdela—Melinta Therapeutics) to treat acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. It is the first fluoroquinolone antibiotic with activity against methicillin-resistant Staphylococcus aureus (MRSA) and, unlike the other fluoroquinolones, is not associated with QT prolongation or photosensitivity. In addition to gram-positive organisms such as MRSA, delafloxacin targets gram-negative pathogens (e.g., Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa).
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