Pharma Business - March 4, 2019
AstraZeneca’s Lynparza receives positive EU opinion
AstraZeneca and MSD have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the use of Lynparza (olaparib) tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or […]
Pharma Business - February 28, 2018
MedImmune to create stand-alone company
AstraZeneca’s global biologics research and development arm, MedImmune, is spinning out six molecules from its early-stage inflammation and autoimmunity programmes into an independent biotech company, Viela Bio. The new company will focus on developing medicines for severe autoimmune diseases by targeting the underlying causes of each disease. MedImmune will contribute three clinical and three pre-clinical […]
Pharma Business - February 19, 2018
FDA approves AstraZeneca’s Imfinzi
AstraZeneca and MedImmune announces that the US Food and Drug Administration (FDA) has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT). “The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful […]
Clinical Trials - February 8, 2018
New results from Astra’s Pegasus trial
AstraZeneca announces results from a new sub-analysis of the Phase III PEGASUS-TIMI 54 trial. The results demonstrates a risk reduction of 19% in MACE (the composite of CV death, myocardial infarction, or stroke) (HR 0.81; 95% CI, 0.7–0.95) and of 36% in coronary death (HR 0.64; 95% CI, 0.45–0.89) from treatment with Brilinta 60mg (ticagrelor), in combination […]
Clinical Trials - January 26, 2018
New results from AstraZeneca’s KRONOS trial
AstraZeneca announces results from their Phase III KRONOS trial showing PT010 demonstrated a statistically significant improvement in eight out of nine lung function primary endpoints based on forced expiratory volume in one second (FEV1) assessments in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). KRONOS is a randomised, double-blind, parallel-group, 24-week, chronic-dosing, […]
Clinical Trials - January 15, 2018
AstraZeneca’s Lynparza approved by FDA
The US Food and Drug Administration has approved Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor positive (HR+) breast cancer should have been treated […]
