Ämnen: Industri, tillverkning

Lynparza regulatory submission granted Priority Review in the US for 1st-line maintenance treatment with bevacizumab in advanced ovarian cancer

13 Januari 2020 08:03

AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced that a supplemental New Drug Application for Lynparza (olaparib) in combination with bevacizumab has been accepted and granted Priority Review in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line platinum-based chemotherapy with bevacizumab.

Update on Phase III STRENGTH trial for Epanova in mixed dyslipidaemia

13 Januari 2020 08:02

Following the recommendation from an independent Data Monitoring Committee, AstraZeneca has decided to close the Phase III STRENGTH trial for Epanova (omega-3 carboxylic acids) due to its low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia (MDL) who are at increased risk of cardiovascular (CV) disease.

Farxiga granted FDA Priority Review for patients with heart failure with reduced ejection fraction

6 Januari 2020 08:10

AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D).

Lokelma approved in China for the treatment of adult patients with hyperkalaemia

6 Januari 2020 08:09

AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) has been approved in China for the treatment of adult patients with hyperkalaemia (elevated levels of potassium in the blood).

Lynparza approved in the US as a 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

30 December 2019 08:02

AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced that Lynparza has been approved in the US for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen.

AstraZeneca’s triple-combination therapy approved in China for patients with COPD

23 December 2019 08:02

AstraZeneca today announced that budesonide/glycopyrronium/formoterol fumarate has been approved in China for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

Enhertu (trastuzumab deruxtecan) approved in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens

21 December 2019 07:57

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

AstraZeneca divests rights to Arimidex and Casodex in Europe and certain additional countries

20 December 2019 08:12

AstraZeneca today announced that it has agreed to sell the commercial rights to Arimidex (anastrozole) and Casodex (bicalutamide) in a number of European, African and other countries to Juvisé Pharmaceuticals.

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

17 December 2019 19:20

AstraZeneca and MSD Inc., Kenilworth, NJ, US today announced that the US FDA Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend Lynparza (olaparib) as a 1st-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer), whose disease has not progressed following 1st-line platinum-based chemotherapy.

Agreement with Cheplapharm for rights to Seroquel and Seroquel XR in Europe and Russia completed

16 December 2019 08:02

​AstraZeneca has completed an agreement to divest its commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia to Cheplapharm Arzneimittel GmbH (Cheplapharm).

Imfinzi approved in China for the treatment of unresectable, Stage III non-small cell lung cancer based on the Phase III PACIFIC trial

12 December 2019 10:10

AstraZenecatoday announced that it has received marketing authorisation from China’s National Medical Products Administration (NMPA) for Imfinzi (durvalumab) for the treatment of patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

Trastuzumab deruxtecan achieved a tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial

11 December 2019 17:26

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody drug conjugate (ADC) and potential new medicine, in patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted regimens.

Calquence significantly prolonged the time patients lived without disease progression or death in previously untreated chronic lymphocytic leukaemia

7 December 2019 13:40

AstraZeneca today presented results from the interim analysis of the Phase III ELEVATE TN trial, showing that Calquence (acalabrutinib) combined with obinutuzumab or as monotherapy significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab, a standard chemo-immunotherapy treatment, in patients with previously untreated chronic lymphocytic leukaemia (CLL).1

Lynparza approved in China as a 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer

5 December 2019 08:02

AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced that the companies have received marketing authorisation from China’s National Medical Products Administration for Lynparza (olaparib) as a 1st-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or primary peritoneal cancer

AstraZeneca divests rights to Seroquel and Seroquel XR in the US and Canada

3 December 2019 08:02

​AstraZeneca has agreed to sell the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in the US and Canada to Cheplapharm Arzneimittel GmbH (Cheplapharm). Seroquel and Seroquel XR, used primarily to treat schizophrenia and bipolar disorder, have lost their compound patent protection in the US and Canada

Imfinzi granted FDA Priority Review for the treatment of patients with extensive-stage small cell lung cancer

29 November 2019 08:02

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC).

Calquence approved in the US for adult patients with chronic lymphocytic leukaemia

21 November 2019 19:18

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).1 The US approval was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programmes.

Qtrilmet approved in the EU for the treatment of type-2 diabetes

15 November 2019 08:02

​AstraZeneca today announced that the European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D).

Anifrolumab demonstrated superiority across multiple efficacy endpoints in patients with systemic lupus erythematosus in Phase III TULIP 2 trial

11 November 2019 17:02

AstraZeneca will tomorrow present detailed results from the positive Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of moderate to severe systemic lupus erythematosus (SLE), which demonstrated superiority across multiple efficacy endpoints versus placebo, with both arms receiving standard of care.

Roxadustat significantly increased haemoglobin levels for chronic kidney disease patients with anaemia in Phase III OLYMPUS and ROCKIES trials

7 November 2019 22:41

AstraZeneca today presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased haemoglobin (Hb) levels in non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anaemia from chronic kidney disease (CKD), respectively.