- Friday, 19 December 2014
- LYNPARZA™ approved by the US food and drug administration for the treatment of advanced ovarian cancer in patients with germline BRCA-mutations AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved LYNPARZA™ (olaparib) capsules (400mg twice daily) as the first monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. Olaparib has been approved under the FDA’s Accelerated Approval programme, based on existing objective response rate and duration of response data. Continued approval for this indication is contingent upon verification of clinical benefit in ongoing confirmatory Phase III trials.
- Thursday, 18 December 2014
- Lynparza™approved in the European Union as first-in-class treatment for advanced BRCA-mutated ovarian cancer AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorisation for Lynparza™ (olaparib) capsules (400mg twice daily) as the first therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.
- Thursday, 11 December 2014
- AstraZeneca and Amgen to present detailed results from Phase III AMAGINE-1™ study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis AstraZeneca and Amgen today announced that additional results from AMAGINE-1™, a pivotal, multi-arm Phase III trial evaluating two doses of brodalumab in patients with moderate-to-severe plaque psoriasis will be presented at the Psoriasis: From Gene to Clinic International Congress in London on Saturday, 13 December 2014 at 11:20 am GMT (Abstract FC30). Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor. The IL-17 receptor and cytokine family play a central role in development and clinical manifestations of plaque psoriasis.
- Tuesday, 9 December 2014
- MOVENTIG® approved in the European Union for opioid-induced constipation AstraZeneca today announced that MOVENTIG® (naloxegol) has been granted Marketing Authorisation by the European Commission (EC) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved in the European Union (EU).
- Friday, 5 December 2014
- Jury verdict favours AstraZeneca in Nexium antitrust litigation AstraZeneca today announced that a jury in the US District Court for the District of Massachusetts returned a verdict in favour of AstraZeneca in a Multi-District antitrust case filed by various purchaser groups challenging the previous settlement of Nexium patent litigation with Ranbaxy.
- Tuesday, 2 December 2014
- New Drug Application for IRESSA accepted by US Food and Drug Administration AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for IRESSA® (gefitinib) as a targeted monotherapy for the first line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), as identified through a companion diagnostic test. The Prescription Drug User Fee Act goal date for IRESSA will be in the third quarter 2015.
- Monday, 1 December 2014
- AstraZeneca and Eli Lilly and Company initiate pivotal clinical trial for patients with early Alzheimer’s disease AstraZeneca and Eli Lilly and Company (Lilly) today announced enrolment of the first patient into AMARANTH, a Phase II/III study of an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease.
- Wednesday, 26 November 2014
- MedImmune completes acquisition of Definiens AstraZeneca today announced that MedImmune, its global biologics research and development arm, completed its acquisition of Definiens, a privately-held company that has pioneered a world-leading imaging and data analysis technology, known as Tissue Phenomics™, which dramatically improves the identification of biomarkers in tumour tissue.
- Tuesday, 25 November 2014
- Amgen and AstraZeneca announce positive results from third and final pivotal Phase III study of Brodalumab in patients with moderate-to-severe plaque psoriasis AstraZeneca and Amgen today announced that AMAGINE-2TM, a pivotal, multi-arm Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. Brodalumab 210 mg given every two weeks and the brodalumab weight-based analysis group were each shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100). When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75 percent improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75). A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo, according to the static Physician Global Assessment (sPGA 0 or 1).
- Monday, 24 November 2014
- Duaklir® Genuair® approved in the European Union for chronic obstructive pulmonary disease AstraZeneca today announced that Duaklir® Genuair® (aclidinium bromide/formoterol fumarate 340/12 mcg) has been granted Marketing Authorisation by the European Commission (EC) to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
We are advancing the science of personalised healthcare with the first lab-based companion diagnostic test approved in US19 Dec
- 18 Dec
@GoDiabetesMD We understand there's a lack of epidemiological studies in the advanced&metastatic space, also noted by advocates&researchers17 Dec