Pharma Business - January 21, 2021
Enhertu approved in the EU for the treatment of HER2-positive metastatic breast cancer
AstraZeneca and Daiichi Sankyo have been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens. The approval by the European Commission was based on positive results from the single-arm DESTINY-Breast01 Phase […]
Pharma Business - January 19, 2021
AstraZeneca’s Imfinzi approved in the EU
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union and the UK for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based […]
Pharma Business - January 18, 2021
AstraZeneca’s Enhertu approved in the US
AstraZeneca and Daiichi Sankyo’s Enhertu has been approved in the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. The approval by the Food and Drug Administration (FDA) was based on the positive results from the randomised DESTINY-Gastric01 […]
Clinical Trials - January 14, 2021
Ultimovacs announces Phase II collaboration study in ovarian cancer
Ultimovacs will participate in the Phase II DOVACC collaboration study with the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca. The collaborators will conduct a randomized Phase II clinical trial to evaluate Ultimovacs’ universal cancer vaccine, UV1, in combination with AstraZeneca’s durvalumab […]
Pharma Business - January 12, 2021
AstraZeneca’s Farxiga granted Priority Review in the US
AstraZeneca’s Farxiga (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). The Food and Drug Administration (FDA) grants Priority Review to regulatory submissions for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, […]
COVID-19 - January 10, 2021
Production and supply – A logistics challenge
The manufacturing, packaging and transportation of COVID-19 vaccines requires a smooth, effective and safe supply chain. Time is of the essence, and the pharma industry supply chain is facing big logistics challenges. In record time the global life science industry has been able to discover and develop one vaccine approved for full use, six vaccines […]
