Clinical Trials - September 11, 2017
Celgene and AstraZeneca report update on clinical trial programme
MedImmune, AstraZeneca’s global biologics R&D arm, have been informed by partner Celgene that the US Food and Drug Administration (FDA) has placed a partial clinical hold on five trials and a full clinical hold on one trial in the Celgene FUSION programme. The trials are testing Imfinzi (durvalumab), an anti-PD-L1 agent, in combination with immunomodulatory agents, with or […]
Collaboration - August 29, 2017
AstraZeneca, Takeda collaborates on Parkinson’s disease drug
AstraZeneca and Takeda Pharmaceutical have entered an agreement to jointly develop and commercialise MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD). Alpha-synuclein (α-synuclein) is an aggregation-prone protein that contributes to the development of PD. This protein is the major constituent of Lewy bodies, which are pathological protein aggregates […]
Drug Development Pharma - August 23, 2017
Lynparza receives additional approval in the US
AstraZeneca and Merck & Co announced that the US Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, Lynparza (olaparib). The approval is as follows: New use of Lynparza as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer who are in response to platinum-based chemotherapy, regardless of BRCA status New […]
Pharma Business - August 8, 2017
AstraZeneca’s Faslodex receives EU approval
The European Commission (EC) has approved Faslodex (fulvestrant) for the treatment of oestrogen-receptor positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. The EU approval is based on pivotal data from the Phase III FALCON trial, which demonstrated the superiority of Faslodex 500mg over anastrozole 1mg as a first-line treatment for postmenopausal women with […]
Collaboration - August 7, 2017
AstraZeneca and Merck enter oncology collaboration
AstraZeneca and Merck & Co have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca’s 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. Lynparza’s pipeline has grown in the last few years, with 14 indications currently being […]
Clinical Trials - August 3, 2017
Positive results from AstraZeneca’s FLAURA trial
The Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC). “The strong results from the FLAURA trial are very exciting news for patients […]
