Drug Development Pharma - January 3, 2018
FDA accepts AZ’s regulatory submission for Tagrisso
The company announced before christmas that the US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell […]
Agreement - November 10, 2017
AstraZeneca and Incyte enter clinical trial collaboration
AstraZeneca and MedImmune announce the expansion of their clinical collaboration with Incyte Corporation. As part of the agreement, the companies will evaluate the efficacy and safety of epacadostat, Incyte’s investigational selective IDO1 enzyme inhibitor, in combination with AstraZeneca’s Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, compared to Imfinzi alone. The exclusive collaboration for the study population allows […]
Pharma Business - November 1, 2017
FDA approval for AstraZeneca’s Calquence
AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, has announced that the FDA has granted accelerated approval to Calquence (acalabrutinib). Calquence is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Calquence is approved under the FDA’s accelerated approval pathway, based […]
Collaboration - October 16, 2017
Billion SEK investment in life science cluster in Mölndal
The investment of 3,5 billion SEK, presented by Next Step and Vectura in collaboration with AstraZeneca, will enable the formation of a new arena for life science and innovation in Gothenburg. The aim is that the new cluster will become a leading international research cluster. It will be established in the area of AstraZeneca’s facilities […]
Pharma Business - October 9, 2017
AstraZeneca granted therapy designation
AstraZeneca has announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). “The Breakthrough Therapy Designation acknowledges not only Tagrisso’s potential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, […]
Agreement - September 15, 2017
AstraZeneca and Aspen in agreement
AstraZeneca has entered into an agreement with Aspen Global Incorporated, part of the Aspen Group, under which AGI will now acquire the residual rights to the established anaesthetic medicines comprising of Diprivan, EMLA,Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest. AstraZeneca entered into an agreement with AGI in June 2016, under which AGI gained the exclusive commercialisation rights to the medicines in markets outside the US. […]
