Ämnen: Industri, tillverkning

CHMP issues a positive opinion for Bevespi Aerosphere for the treatment of chronic obstructive pulmonary disease

19 Oktober 2018 14:24

AstraZeneca today announced that the CHMP of the European Medicines Agency has adopted a positive opinion, recommending the marketing authorisation for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve symptoms inadult patients with chronic obstructive pulmonary disease (COPD).

US FDA grants Lynparza Orphan Drug Designation for pancreatic cancer

16 Oktober 2018 08:01

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US today announced that they were granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for Lynparza (olaparib) for the treatment of pancreatic cancer.

AstraZeneca presents advances in improving treatment options for ovarian and lung cancer patients at ESMO 2018

9 Oktober 2018 15:07

AstraZeneca and MedImmune, its global biologics research and development arm, will present 54 abstracts, including eight oral presentations and three late breakers, to the European Society of Medical Oncology (ESMO 2018) Congress in Munich, Germany, 19-23 October.

Christina Malmberg Hägerstrand ny presschef för AstraZeneca i Norden och Baltikum

5 Oktober 2018 09:07

AstraZeneca meddelar i dag att man har anställt Christina Malmberg Hägerstrand i en ny roll som presschef för bolaget i Norden och Baltikum. Hon börjar den 7 januari 2019 och kommer rapportera till Kommunikationsdirektör Jacob Lund.

Imfinzi is the first immunotherapy to demonstrate significant overall survival benefit in unresectable, Stage III lung cancer

25 September 2018 14:21

Results from the Phase III PACIFIC trial were published simultaneously in the New England Journal of Medicine, showing Imfinzi (durvalumab) significantly improved OS, the second primary endpoint of the trial, compared to standard of care regardless of PD-L1 expression, reducing the risk of death by 32% (HR 0.68, 99.73% CI 0.47-0.997; p=0.0025).

Bydureon receives positive EU CHMP opinion for EXSCEL cardiovascular outcomes data

25 September 2018 08:02

Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolic Diseases, at AstraZeneca said: “We are pleased with this positive recommendation for Bydureon and what it means for patients with type-2 diabetes with a wide range of cardiovascular risk. Our pursuit of this label is based on our strong belief in the clinical value the EXSCEL data brings to physicians and patients.”

European Commission approves Imfinzi for locally-advanced, unresectable NSCLC

24 September 2018 17:13

AstraZeneca and MedImmune, today announced that the European Commission has granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).

Forxiga uppnådde ett positivt resultat i fas III-studien DECLARE TIMI 58, en stor kardiovaskulär studie med 17 000 patienter med typ 2-diabetes

24 September 2018 08:03

AstraZeneca meddelade i dag positiva övergripande resultat från den kardiovaskulära fas III-studien DECLARE-TIMI 58 for Forxiga (dapagliflozin), den bredaste kardiovaskulära studien hittills för en SGLT2-hämmare.

AstraZeneca presents further data showing the interconnectivity between cardiovascular and renal risks in diabetes at EASD 2018

20 September 2018 12:26

AstraZeneca and MedImmune, its global biologics research and development arm, will present more than 50 abstracts from the Company’s Cardiovascular, Renal & Metabolism (CVRM) therapy area at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin, Germany, 1-5 October 2018.

Fasenra shows consistent safety and sustained efficacy in long-term Phase III BORA trial in severe eosinophilic asthma

18 September 2018 08:04

AstraZeneca today announced results from the BORA Phase III extension trial evaluating the long-term safety and efficacy of Fasenra (benralizumab) as an add-on maintenance treatment in patients with severe eosinophilic asthma who had previously completed one of the two pivotal SIROCCO or CALIMA Phase III trials.

The Lancet Respiratory Medicine publishes first Phase III trial for PT010 triple combination therapy in moderate to very severe chronic obstructive pulmonary disease

16 September 2018 17:29

Data from the KRONOS trial presented at the European Respiratory Society (ERS) International Congress 2018

US FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukaemia

13 September 2018 22:18

AstraZeneca and MedImmune, announced today that the US FDA has approved Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min).

AstraZeneca to present Fasenra long-term safety and efficacy data at European Respiratory Society International Congress 2018

13 September 2018 08:04

AstraZeneca and MedImmune, today announced that new data from the BORA Phase III extension trial of Fasenra (benralizumab) is among 43 company abstracts accepted for oral and poster presentation at the European Respiratory Society (ERS) International Congress 2018, 15-19 September in Paris.

Tezepelumab granted Breakthrough Therapy Designation by US FDA

7 September 2018 08:03

AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.

Update on TULIP 1 Phase III trial for anifrolumab in systemic lupus erythematosus

31 Augusti 2018 08:04

AstraZeneca and MedImmune, today announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLEas measured by the SLE Responder Index 4 (SRI4)at 12 months.

European Commission approves new easy-to-use, once-weekly Bydureon BCise device for patients with type-2 diabetes

30 Augusti 2018 08:02

AstraZeneca today announced that the European Commission (EC) has approved Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) as a new formulation within the marketing authorisation for Bydureon (exenatide extended release) for the treatment of patients with type-2 diabetes.

AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere in chronic obstructive pulmonary disease

23 Augusti 2018 14:08

AstraZeneca today announced top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

Tagrisso approved in Japan for 1st-line treatment of EGFR-mutated non-small cell lung cancer

21 Augusti 2018 08:01

AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review.

AstraZeneca is advancing understanding of cardio-renal-metabolic interconnectivity with new evidence at ESC 2018

20 Augusti 2018 08:02

New evidence of the persistency of ischaemic risk in post-heart attack patients, highlighting specific risk factors that may help identify patients for extended DAPT Latest data on the links between RAAS inhibitor dose reduction and increased risk of mortality and MACE in heart failure patients with hyperkalaemia

Selumetinib granted orphan designation in Europe for neurofibromatosis type 1

3 Augusti 2018 08:19

AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).