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Bristol-Myers (BMY) Reports Positive Data on Leukemia Drug.
Bristol-Myers Squibb Company BMY announced positive data from phase II study, CA180-372, on Sprycel.
Patients received Sprycel 60 mg/m2tablets or powder for oral suspension, once daily, in addition to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone for two years or until the occurrence of unacceptable toxicity in the ongoing CA180-372 (NCT01460160) study.
December 12, 2017 Zacks.com
CVS-Aetna Deal Leading a Wave of Change in Hospital Sector.
The mega merger of CVS Health Corp. CVS with Aetna Inc. AET announced recently has sent jitters across the hospital sector, which is already suffering from low patient volumes, soaring costs, increasing bad debts, and an uncertain regulatory climate among other issues.
December 12, 2017 – Zacks.com
Merck’s Keytruda Gets FDA Priority Review for Rare Lymphoma.
Merck MRK announced that the FDA has granted priority review to its supplemental biologics license application (sBLA) looking for label expansion of its marketed drug, Keytruda (pembrolizumab), for a rare lymphoma indication.
The sNDA is looking to expand Keytruda’s label for treatment of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma (“NHL”).
With the FDA granting a priority review, its response is expected on Apr 3, 2018.
If finally approved, this would be the second nod for Keytruda from the regulatory body for treating a hematologic malignancy indication.
December 12, 2017 – Zacks.com
Novartis Announces Positive Data on Sickle Cell Disease Drug.
Novartis AG NVS announced positive results from a post hoc subgroup analysis of the phase II study, SUSTAIN on pipeline candidate, crizanlizumab.
The multicenter, multinational, randomized, placebo-controlled, double-blind, 12-month study was conducted to evaluate the safety and efficacy of the anti-P-selectin antibody crizanlizumab with or without concomitant use of hydroxyurea therapy in patients with sickle cell-related pain crises.
December 12, 2017 – Zacks.com