Pharma Business - May 11, 2022
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 unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing […]
Pharma Business - May 6, 2022
AstraZeneca’s Imfinzi plus chemotherapy granted Priority Review
AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi, in combination with standard-of-care chemotherapy, has been accepted and granted Priority Review in the US for patients with locally advanced or metastatic biliary tract cancer (BTC). The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over […]
Pharma Business - May 4, 2022
AstraZeneca’s Ultomiris approved in the US
Ultomiris has been approved for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive, which represents 80% of people living with the disease. “Since bringing forward thefirst complement inhibitor, we’ve continued to listen to the community and focused innovation on the needs of gMG patients. We’re proud to […]
Pharma Business - May 2, 2022
AstraZeneca announces plans for new strategic R&D centre
AstraZeneca has announced plans to open a new site at the heart of the Cambridge, MA, life sciences and innovation hub. The new site will be a strategic R&D centre for AstraZeneca, as well as Alexion’s new corporate headquarters. The site will bring together approximately 1,500 R&D, commercial and corporate colleagues into a single purpose-built […]
Pharma Business - April 27, 2022
AstraZeneca’s tremelimumab accepted under Priority Review in the US
AstraZeneca’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi for the treatment of patients with unresectable hepatocellular carcinoma (HCC). A supplemental BLA (sBLA) has also been submitted for Imfinzi in this indication. This […]
New Market - March 29, 2022
AstraZeneca’s Ondexxya approved in Japan
Ondexxya has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ANNEXA-4 Phase III clinical trial showing […]
