Ämnen: Industri, tillverkning

US FDA accepts regulatory submission for Lynparza maintenance therapy in newly-diagnosed, BRCA-mutated advanced ovarian cancer and grants Priority Review

12 November 2018 08:07

AstraZeneca and Merck & Co., Inc. US today announced that the US FDA has accepted a supplemental New Drug Application for Priority Review for the use of Lynparza tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following 1st-line standard platinum-based chemotherapy.

Farxiga significantly reduced hospitalisation for heart failure or CV death in a broad patient population with type-2 diabetes in the landmark DECLARE-TIMI 58 trial

10 November 2018 22:48

Fewer MACE events observed with Farxiga vs. placebo, but this finding did not reach statistical significance No imbalance in amputations, fractures, bladder cancer or Fournier’s gangrene with Farxiga vs. placebo

AstraZeneca PLC:s resultatrapport för de första nio månaderna och tredje kvartalet 2018

8 November 2018 08:02

AstraZeneca återgår till tillväxt i produktförsäljningen; nya läkemedel och tillväxtmarknaderna leder vägen

Divestment of rights to Alvesco, Omnaris and Zetonna to Covis Pharma

6 November 2018 08:02

AstraZeneca has entered into an agreement with Covis Pharma B.V. (Covis Pharma) to sell its rights to the medicines Alvesco (ciclesonide), usedfor the treatment of persistent asthma, and Omnaris and Zetonna (ciclesonide), used for the treatment of nasal symptoms associated with rhinitis. The rights cover markets outside the US and the US royalties for the medicines.

The landmark DECLARE-TIMI 58 cardiovascular outcomes trial of Farxiga in patients with type-2 diabetes to be featured at AHA 2018

1 November 2018 08:02

AstraZeneca will present 20 abstracts including a late-breaking oral presentation on the full results from the Phase III CV outcomes trial (CVOT) DECLARE-TIMI 58, the broadest SGLT2 inhibitor CVOT conducted to date, as well as new research from the Company’s CVRM therapy area at the American Heart Association (AHA) Scientific Sessions, 10-12 November 2018, in Chicago, Illinois, USA.

Agreement with Grünenthal for rights to Nexium in Europe and Vimovo worldwide (ex-US)

30 Oktober 2018 08:03

AstraZeneca has agreed to divest the prescription medicine rights to Nexium(esomeprazole) in Europe, as well as the global rights (excluding the US and Japan) to Vimovo (naproxen/esomeprazole) to Grünenthal. The medicines are outside AstraZeneca’s three main therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory

Phase III HARMONIZE Global trial of Lokelma confirms efficacy in maintaining normal potassium levels in Asian patients with hyperkalaemia

25 Oktober 2018 19:03

AstraZeneca today presented the results from the HARMONIZE Global Phase III trial, which investigated the safety and efficacy of Lokelma (sodium zirconium cyclosilicate) vs. placebo in patients with hyperkalaemia in Japan, Korea, Taiwan and Russia. The results were presented at the American Society of Nephrology (ASN) Kidney Week 2018, San Diego, California, US.

AstraZeneca strengthens and expands oncology development and commercialisation collaboration with Innate Pharma

23 Oktober 2018 08:09

AstraZeneca, and its global biologics research and development arm MedImmune, today announced a new multi-term agreement with Innate Pharma (Innate), building on an existing collaboration, aimed at accelerating each company’s oncology portfolio and bringing new medicines to patients more quickly.

AstraZeneca to present new data demonstrating breadth of research portfolio in renal disease at ASN Kidney Week 2018

22 Oktober 2018 08:10

AstraZeneca will present new research spanning the Company’s Cardiovascular, Renal and Metabolism (CVRM) therapy area at the American Society of Nephrology (ASN) Kidney Week Annual Meeting in San Diego, US, 23-28 October 2018.

SOLO-1 Phase III trial demonstrates Lynparza maintenance therapy cut risk of disease progression or death by 70% in patients with newly-diagnosed, advanced BRCA-mutated ovarian cancer

21 Oktober 2018 16:46

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US today announced detailed results from the Phase III SOLO-1 trial testing Lynparza (olaparib) tablets as a maintenance treatment for patients with newly-diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or partial response following 1st-line standard platinum-based chemotherapy.

New data on mechanisms of acquired resistance after 1st-line Tagrisso in NSCLC support initiation of ORCHARD trial to explore post-progression treatment options

19 Oktober 2018 16:02

AstraZeneca today presented new data on the mechanisms of acquired resistance from the Tagrisso (osimertinib) pivotal Phase III FLAURA trial during an oral late-breaker abstract session at the European Society of Medical Oncology (ESMO) 2018 Congress in Munich, Germany.

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.