Specialty Pharma Journal Specialty, Precision & Technology
NORTH CHICAGO, Ill., Aug. 27, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) plus rituximab (RITUXAN®) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), a rare and incurable type of non-Hodgkin’s lymphoma (NHL). With this approval, the …
Tag Archives: Waldenstrom’s macroglobulinemia
August, 2018
December, 2017
-
7 December
Imbruvica in Combination with Rituximab Meets Primary Endpoint in Phase 3 Waldenström’s Macroglobulinemia Study
RARITAN, N.J., Dec. 5, 2017 /PRNewswire/ — Janssen Research & Development, LLC (Janssen) announced that the Phase 3 iNNOVATE (PCYC-1127) study evaluating IMBRUVICA® (ibrutinib) in combination with rituximab (RITUXAN®) in relapsed/refractory and treatment-naïve patients with Waldenström’s macroglobulinemia (WM) successfully met its primary endpoint of progression-free survival (PFS). An Independent Data …
February, 2016
-
25 February
AstraZeneca and Acerta Pharma’s Acalabrutinib Recommended for EU Orphan Status for 3 Indications
AstraZeneca and Acerta Pharma BV, a company in which AstraZeneca has a majority equity investment, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product. The three positive opinions are for the …
April, 2015
-
10 April
New Drug for Rare Lymphoma Demonstrates Sustained Benefit at Two Years
New data shows that Pharmacyclics and partner Janssen’s Imbruvica (ibrutinib) provides ongoing control of Waldenstrom’s macroglobulinemia (WM). Investigators from Dana-Farber Cancer Institute reported that the most recent results from a clinical trial show that ibrutinib continued to control the rare blood cancer, with 95 percent of patients surviving for two …