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Calquence Earns Breakthrough Therapy Designation

AstraZeneca’s BTK inhibitor Calquence won Breakthrough Therapy Designation from the U.S. FDA as a monotherapy treatment for patients with chronic lymphocytic leukemia (CLL).

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FDA Approves Pfizer’s Biosimilar Ruxience for Certain Cancers and Autoimmune Conditions

The U.S. Food and Drug Administration approved Pfizer Inc.’s Ruxience (rituximab-pvvr) – a biosimilar to Rituxan (rituximab) – for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

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Genmab Raises $506 Million in IPO

Copenhagen, Denmark-based Genmab A/S raised $506 million with an initial public offering (IPO), with the company trading on the Nasdaq under the ticker symbol GMAB.

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Calquence Significantly Prolonged Time Patients Lived without Disease Progression in Relapsed or Refractory Chronic Lymphocytic Leukemia

AstraZeneca announced detailed results from the interim analysis of the Phase III ASCEND trial at the European Hematology Association Annual Congress in Amsterdam, showing Calquence (acalabrutinib) significantly prolonged the time patients lived without disease progression in relapsed or refractory chronic lymphocytic leukemia.

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AstraZeneca’s blood cancer drug meets main goal in late-stage trial

AstraZeneca Plc’s blood cancer drug Calquence met the main goal of a final-stage study.

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Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia

The U.S. Food and Drug Administration approved a treatment using Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia.

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AstraZeneca Halts Phase III CLL Trial Early After Primary Endpoints Are Met

AstraZeneca’s Calquence (acalabrutinib) hit the mark in a Phase III trial of previously treated patients with chronic lymphocytic leukemia (CLL).

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FDA puts partial clinical study hold on Venclexta

The U.S. Food and Drug Administration placed a partial clinical hold on all trials of AbbVie’s Venclexta for multiple myeloma, after a review of data found a higher proportion of deaths in the cancer drug arm of the late-stage study.

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FDA Approves Imbruvica for 10th Time

FDA approved Imbruvica combined with Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma.

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Imbruvica fails to meet pancreatic cancer study goal

AbbVie Inc.’s blockbuster cancer treatment Imbruvica in combination with chemotherapy agents failed to meet the main goal in a late-stage study of patients with a form of pancreatic cancer.

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