November 15, 2017
FDA OK’s AstraZeneca’s breast cancer drug
US Food and Drug Administration (FDA) has approved a new indication for AstraZeneca’s Faslodex(fulvestrant), expanding the indication to include use with…
Pharmaceuticals, Biotechnology and Life Sciences
Tag: AstraZeneca
October 30, 2017
Mereo BioPharma agrees with AstraZeneca for exclusive license and option to acquire AZD9668
Mereo BioPharma has made a deal with AstraZeneca for an exclusive license, including an option to acquire, AZD9668, an oral inhibitor…
October 18, 2017
AstraZeneca and Merck said Wednesday that th eUS Food and Drug Administration (FDA) has accepted and granted priority review for a…
October 17, 2017
FDA accepts supplemental BLA for AZ’s Imfinzi in certain lung cancer
The US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for AstraZeneca’s Imfinzi (durvalumab) for the treatment of…
October 9, 2017
AstraZeneca’s Tagrisso gets BTD for certain lung cancer
AstraZeneca Monday said that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the…
September 7, 2017
Duaklir good for combo option for COPD patients in US
Top-line results from the AstraZeneca’s Phase III AMPLIFY trial for Duaklir met its primary endpoints, demonstrating a statistically-significant improvement in lung function in patients with moderate to very severe stable chronic obstructive pulmonary disease (COPD) compared to each individual component, the company said Thursday. In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily.
September 7, 2017
AZ, Amgen: TSLP is an important mediator of inflammation in severe asthma
AstraZeneca and Amgen on Thursday published results from the PATHWAY Phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. The trial results were published in the New England Journal of Medicine. The PATHWAY trial achieved its primary efficacy endpoint, showing annual asthma exacerbation rate reductions.
August 18, 2017
AZ, Merck: Lynparza gets additional and braod approval in the US for ovarian cancer
AstraZeneca’s and Merck’s Lynparza new tablet’s formulation has been approved as maintenance treatment for women with platinum-sensitive recurrent ovarian cancer regardless of BRCA-mutation status, the companies said Friday.
August 2, 2017
FDA accepts AstraZeneca’s drug for multiple B-cell and other cancers.
The US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor, developed by AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma. This potential new medicine is in development for the treatment of multiple B-cell and other cancers.
July 27, 2017
Merck, AstraZeneca in a $8.5 billion oncology deal
AstraZeneca and Merck on Thursday said that they have made a deal to co-develop and co-commercialise AstraZeneca’s oncology product Lynparza (olaparib) for multiple cancer types. Lynparza is an oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.