AstraZeneca

AstraZeneca provides update on GALATHEA Phase III trial for Fasenra in chronic obstructive pulmonary disease

11 Maj 2018 08:01

GALATHEA Phase III trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD
Second Phase III trial TERRANOVA is ongoing with results expected later this quarter
AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab

Lynparza tablets receive EU approval for the treatment of platinum-sensitive relapsed ovarian cancer

8 Maj 2018 12:23

AstraZeneca and Merck & Co., Inc. today announced that the EMA has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.

AstraZeneca and Luye Pharma Group enter agreement for rights to Seroquel and Seroquel XR in the UK, China and other international markets

7 Maj 2018 15:07

AstraZeneca has entered into an agreement with Luye Pharma Group, Ltd. (Luye Pharma) for the sale and licence of the rights to Seroquel and Seroquel XR in the UK, China and other international markets.

Tagrisso receives positive EU CHMP opinion for 1st-line treatment of EGFR-mutated non-small cell lung cancer

27 April 2018 13:32

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a change to the terms of the Marketing Authorisation for Tagrisso to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

Ny studie: Patienter med svår astma träffar sällan en läkare trots att varannan patient har en okontrollerad sjukdom

27 April 2018 08:09

Inför Världsastmadagen 1 maj: I PACEHR-studien har fler än 18,500 astmapatienter i Sverige studerats. Majoriteten hade en lindrig och medelsvår astma och 790 personer hade svår astma. Data från 36 vårdcentraler runt om i Sverige jämfördes med uppgifter från hälsoregister under åren 2006-2013. Syftet med studien var att beskriva förekomst, samsjuklighet, dödlighet och behandling av svår astma.

AstraZeneca reports results from the ARCTIC trial in third-line non-small cell lung cancer

24 April 2018 08:04

AstraZeneca and MedImmune, its global biologics research and development arm, today announced high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least two prior treatments.

US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer

19 April 2018 08:01

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test.

Updated overall survival data for Lynparza in BRCA-mutated HER2-negative metastatic breast cancer presented at AACR

16 April 2018 08:01

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data from the Phase III OlympiAD trial showing the final overall survival (OS) results for Lynparza (olaparib) in metastatic breast cancer at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, US, 14-18 April 2018.

1st-line Tagrisso demonstrates sustained benefit post progression in patients with EGFR-mutated non-small cell lung cancer

13 April 2018 16:58

AstraZeneca today presented new post-progression outcomes data from an exploratory analysis of the global Phase III FLAURA trial, which assessed the efficacy and safety of Tagrisso (osimertinib) as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

AstraZeneca’s early and late-stage oncology portfolio showcased at AACR annual meeting and ELCC

4 April 2018 12:01

AstraZeneca and MedImmune, its global biologics research and development arm, will present updates from their early and late stage oncology pipelines at two major congresses this month. In total, 98 abstracts were accepted for the European Lung Cancer Conference (ELCC) in Geneva,11-14 April, and the American Association for Cancer Research (AACR) annual meeting in Chicago,14-18 April.

The European Medicines Agency accepts regulatory submission for Lynparza in BRCA-mutated, HER2-negative metastatic breast cancer

3 April 2018 08:03

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the European Medicines Agency has validated for review the Marketing Authorisation Application (MAA) for Lynparza (olaparib).

US FDA accepts Biologics License Application for moxetumomab pasudotox in hairy cell leukaemia

3 April 2018 08:03

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukaemia (HCL).

Lokelma approved in the EU for the treatment of adults with hyperkalaemia

22 Mars 2018 17:58

Patients will benefit from Lokelma’s rapid reduction and sustained control of potassium levels in the blood4,5
AstraZeneca today announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious condition characterised by elevated potassium levels in th

Michelle Werner ny marknadsbolagschef för AstraZeneca Nordic-Baltic

14 Mars 2018 14:13

Michelle Werner har tillträtt som chef för AstraZenecas nordisk-baltiska marknadsbolag. Hon kommer närmast från en tjänst som chef för AstraZenecas verksamhet inom cancer i USA. Michelle har arbetat på AstraZeneca i snart tre år, och på ett antal andra läkemedelsföretag under totalt 20 år, bland annat i Frankrike och Storbritannien.
”Jag är verkligen glad över att ha fått möjligheten att leda d

AstraZeneca provides update on MYSTIC trial timeline

12 Mars 2018 08:04

AstraZeneca and MedImmune, today announced an updated timeline for the final analysis of the Phase III MYSTIC trial of Imfinzi (durvalumab). Based on current predictions, the final analysis of overall survival (OS) is now expected in the second half of 2018 (previously anticipated in the first half).

New data from landmark CVD-REAL study of patients with type-2 diabetes confirms CV benefits associated with SGLT-2 inhibitors

11 Mars 2018 21:51

Real-world evidence study of more than 400,000 patients with type-2 diabetes, 74% of whom did not have a history of established cardiovascular disease, supports the association of CV benefits with use of Farxiga Latest analysis includes heart attack and stroke endpoints, longer follow-up period and six additional countries across Asia Pacific, the Middle East and North America