Pharma Business - April 24, 2017
Tagrisso receives full approval in the EU
AstraZeneca announces that the European Commission (EC) has granted full marketing authorisation for Tagrisso (osimertinib) 40mg and 80mg once-daily tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). The full approval for Tagrisso is based on the results of the Phase […]
Drug Development Pharma - March 31, 2017
Tagrisso receives US FDA full approval
The US Food and Drug Administration has granted full approval for Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. […]
Drug Development Pharma - March 30, 2017
Orphan designation for AstraZeneca
AstraZeneca and its global biologics research and development arm, MedImmune, has announced that the European Medicines Agency (EMA) has granted orphan designation to inebilizumab (formerly MEDI-551) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Developed by MedImmune, inebilizumab is currently in Phase IIb clinical development for NMOSD. “The EMA’s orphan designation for inebilizumab underscores the […]
Clinical Trials - March 17, 2017
New data from AZ’s Phase III solo-2 study
AstraZeneca presented results from the Phase III SOLO-2 trial demonstrating a significant improvement in progression-free survival in germline BRCA-mutated, platinum-sensitive, relapsed ovarian cancer patients treated with Lynparza tablets compared with placebo in the maintenance setting. PFS as measured by Blinded Independent Central Review (BICR)evaluation, a pre-specified analysis supporting the primary endpoint, demonstrated a median PFS […]
Drug Development Pharma - February 28, 2017
FDA approves once-daily Qtern tablets for adults with type-2 diabetes
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. The new medicine is indicated as an adjunct to diet and exercise to improve glycaemic (blood sugar level) control in adults with type-2 diabetes who have inadequate control with […]
Agreement - February 22, 2017
AstraZeneca in agreement with TerSera Therapeutics
AstraZeneca has entered into an agreement with TerSera Therapeutics (TerSera) for the commercial rights to Zoladex (goserelin acetate implant) in the US and Canada. Zoladex is an injectable luteinising hormone-releasing hormone agonist, used to treat prostate cancer, breast cancer and certain benign gynaecological disorders. It was first approved in the US and Canada in 1989. […]
