AstraZeneca Pharmaceuticals

AstraZeneca Pharmaceuticals
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Phase III trial evaluating Imfinzi and epacadostat in patients with locally-advanced, unresectable non-small cell lung cancer is expected to begin in the first half of 2018
AstraZeneca and MedImmune, its global biologics research and development arm, today announced the expansion of their clinical collaboration with Incyte Corporation. As part...

New formulation of once-weekly exenatide in an improved device provides significant HbA1c reduction with added benefit of weight loss 23 October 2017 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved...

Lynparza has the potential to offer a new treatment option for patients with germline BRCA-mutated, HER2-negative metastatic breast cancer Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer 18 October 2017 AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the...

Imfinzi granted Priority Review Acceptance follows FDA’s Breakthrough Therapy Designation 17 October 2017 AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the...

Designation based on positive Phase III FLAURA trial results Sixth Breakthrough Therapy Designation for an AstraZeneca New Oncology medicine
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with...

AstraZeneca, along with MedImmune, its global biologics research and development arm, has announced that the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Imfinzi (durvalumab) for the treatment of patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease...

New sub-analysis to be presented at the European Society of Cardiology (ESC) congress provides additional evidence of cardiovascular (CV) benefits associated with longer-term use of Brilinta 24 August 2017 AstraZeneca today announced results from a new sub-analysis of data from the Phase III PEGASUS-TIMI 54 trial demonstrating a 29% risk reduction...

Lynparza’s new tablet formulation approved as maintenance treatment for women
with platinum-sensitive recurrent ovarian cancer regardless of BRCA-mutation status Lynparza tablets also indicated in BRCA-mutated ovarian cancer beyond the third-line setting Newly-approved tablet formulation means improved patient convenience 17 August 2017...

Fourth Breakthrough Therapy Designation for an AstraZeneca New Oncology medicine in three years 31 July 2017 AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients...

Imfinzi plus tremelimumab combination did not meet a primary endpoint of progression-free survival compared to chemotherapy The MYSTIC trial continues as planned to assess the additional primary endpoints of overall survival for Imfinzi monotherapy and for the Imfinzi plus tremelimumab combination 27 July 2017 AstraZeneca and MedImmune, its global...