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    http://www.astrazeneca.se
  • Freja Annamatz

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    Lynparza receives approval in Japan for the treatment of advanced ovarian cancer

    Lynparza is the first PARP inhibitor approved in Japan Lynparza tablets approved as maintenance treatment for women with platinum-sensitive relapsed ovarian cancer regardless of BRCA mutation statusAstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the Japanese Ministry of Health, Labour and Welfare has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last

    Fasenra receives approval in Japan

    Approval based on Phase III WINDWARD programme that demonstrated significantreductions in asthma exacerbations, improvements in lung function and reductions inoral corticosteroid use from baseline, versus placebo Fasenra is the first approved respiratory biologic with an 8-week maintenance dosing scheduleAstraZeneca and its global biologics research and development arm, MedImmune, today announced that the Japanese Ministry of Health, Labour and Welfare has approved Fasenra (benralizumab) as an add-on treatment for bronchial asthma in patients who continue to experience asthma

    US FDA accepts regulatory submission for acalabrutinib and grants priority review

    AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor. The NDA is based on results from the Phase II ACE-LY-004 clinical trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one prior therapy. This follows the FDA’s recent

    Acalabrutinib granted breakthrough therapy designation by US FDA for the treatment of patients with mantle cell lymphoma

    AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers. The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that

    Imfinzi granted breakthrough therapy designation by US FDA for patients with locally-advanced unresectable non-small cell lung cancer

    Fourth Breakthrough Therapy Designation for an AstraZeneca New Oncology medicine in three yearsAstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at

    KYNTHEUM APPROVED IN THE EU FOR THE TREATMENT OF ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS

    Kyntheum is the first and only fully-human monoclonal antibody that selectively targets the IL-17 receptor subunit A on skin cellsAstraZeneca and MedImmune, its global biologics research and development arm, today announced that its partner LEO Pharma has been granted full marketing authorisation in all 28 EU member countries plus Iceland, Liechtenstein and Norway for Kyntheum (brodalumab), a new biologic medicine developed for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.1 Kyntheum is the first and only biologic that selectively

    AstraZeneca’s antibiotic Zavicefta met primary endpoints in phase III trial for treatment of hospital-acquired pneumonia

    AstraZeneca today announced positive results from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for the treatment of a broad range of serious Gram-negative bacterial infections in hospitalised patients. Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant to current antibiotics commonly used for serious infections, such as carbapenems and polymixins, including colistin.The REPROVE trial assessed the efficacy of Zavicefta (ceftazidime-avibactam)

    ASTRAZENECA RECEIVES APPROVAL IN THE EU FOR QTERN (SAXAGLIPTIN AND DAPAGLIFLOZIN) FOR TREATMENT OF TYPE 2 DIABETES

    AstraZeneca today announced that the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway. The fixed-dose combination of saxagliptin and dapagliflozin is the first DPP-4i/SGLT-2i combination product to be approved in Europe.Qtern is indicated for adults with type 2 diabetes aged 18 years and older to improve glycaemic control when metformin and/or sulphonylurea and one of the mono-components of Qtern alone do not provide adequate control, or when a patient is

    AstraZeneca further sharpens focus through agreement with Genzyme for rare disease medicine Caprelsa

    27 July 2015 AstraZeneca today announced that it has entered into a definitive agreement with Genzyme to divest Caprelsa® (vandetanib), a rare disease medicine. Caprelsa was granted Orphan Drug Designation by the US FDA in 2005 and is currently available in 28 countries for the treatment of aggressive and symptomatic medullary thyroid carcinoma, with global product sales of $48 million in 2014. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300 million, including an upfront payment of $165 million to acquire the global rights to sell and develop Caprelsa, and

    AstraZeneca provides update on selumetinib in uveal melanoma

    22 July 2015 AstraZeneca today announced that the Phase III SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary programme in second-line KRAS-mutant advanced non-small cell lung cancer in

    Iressa approved by US FDA for first-line treatment of patients with advanced EGFR mutation-positive non-small cell lung cancer

    13 July 2015 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved IRESSA (gefitinib) tablets, 250mg once daily, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test. IRESSA is an oral, EGFR tyrosine kinase inhibitor (TKI), which works by blocking the activity of the EGFR tyrosine kinase enzyme responsible for regulating signalling pathways implicated in the

    ASTRAZENECA SHARPENS FOCUS ON MAIN THERAPY AREAS THROUGH AGREEMENT WITH GASTROENTEROLOGY SPECIALIST TILLOTTS PHARMA FOR ENTOCORT

    AstraZeneca announced today that it has entered into an agreement with Tillotts Pharma AG (Tillotts), part of the Zeria Group, for the divestment of global rights, outside the US, to Entocort (budesonide), a gastroenterology medicine for patients with mild to moderate Crohn’s disease and ulcerative colitis. Entocort is currently available in over 40 countries, with total product sales of $53 million outside the US in 2014. A regulatory submission for Entocort in Japan is anticipated in the coming months.09 July 2015 AstraZeneca announced today that it has entered into an agreement with

    AstraZeneca to present new data from its growing inflammation and autoimmunity pipeline at American College of Rheumatology 2014 annual meeting

    AstraZeneca, with its global biologics research and development arm, MedImmune, will present new data from the company’s growing inflammation and autoimmunity portfolio at the American College of Rheumatology (ACR) 2014 Annual Meeting in Boston, Massachusetts, 14-19 November 2014. More than 15 abstracts will be featured at the ACR meeting, providing evidence of the depth and continued progress of AstraZeneca’s inflammation and autoimmunity pipeline. Positive Phase III data will be presented on lesinurad in gout, as well as earlier stage data around a number of innovative investigational

    AstraZeneca advances tralokinumabto phase III in severe asthma

    AstraZeneca today announced the start of the Phase III programme for tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by MedImmune, the company’s global biologics research and development arm. The Phase III programme will evaluate the safety and effectiveness of tralokinumab in reducing the rate of asthma exacerbations (AER) in adults and adolescents with severe, inadequately controlled asthma despite receiving inhaled corticosteroids plus long-acting β2-agonist. The programme will also assess the effect of tralokinumab on lung

    AstraZeneca announces top-line results from the phase III programme of lesinurad in combination with xanthine oxidase inhibitors in gout patients

    AstraZeneca today announced positive top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy for the treatment of patients with symptomatic gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid (sUA). CLEAR1 and CLEAR2 studied lesinurad (200mg and 400mg once daily) in combination with the xanthine oxidase (XO) inhibitor allopurinol, in

    Stort intresse för AstraZenecas Sommarforskarskola som idag startar i Göteborg

    Platserna tog snabbt slut och väntelistorna är långa till AstraZenecas Sommarforskarskola 2014 som drar i gång på Göteborgs universitet idag. Intresset står i kontrast till den sedan länge förutspådda bristen på ingenjörer, tekniker och naturvetare de kommande åren. -När elevernas egen nyfikenhet sätts i centrum så ser vi att naturvetenskap och teknik blir attraktivt och roligt, säger Laura Alexis, koordinator för AstraZenecas Sommarforskarskola. 53 elever i åldern 14-17 år deltar mellan 4-15 aug i spännande laborationer, lektioner och studiebesök. De bygger till exempel egna ”

    Medimmune and Advaxis partner on immuno-oncology combination clinical trial

    22 July 2014 AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis, Inc., a US-based biotechnology company developing cancer immunotherapies. The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis’ lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer

    AstraZeneca and MRC Laboratory of Molecular Biology to launch joint research fund

    AstraZeneca today announced its intention to collaborate with the Medical Research Council Laboratory of Molecular Biology (MRC LMB) to fund a range of pre-clinical research projects aimed at better understanding the biology of disease. Projects supported by the fund are likely to involve scientists from the two organisations working side by side, either within the MRC LMB at the Cambridge Biomedical Campus, the site of the company’s future strategic R&D centre and global corporate headquarters, or in AstraZeneca and MedImmune research facilities. As part of the planned collaboration,

    Continuing progress in accelerating late stage pipeline reinforces confidence in AstraZeneca’s strategy as an independent company

    This week AstraZeneca demonstrated further evidence of continued progress of its science-led strategy, as the company updated on new data in advance of key medical and scientific congresses across all of its core therapeutic areas – oncology, cardiovascular and metabolic disease and respiratory, inflammation and autoimmunity.  Pascal Soriot, Chief Executive of AstraZeneca, said: “We continue to build our pipeline and we are encouraged by the progress in the development of key assets. We have complete confidence in our strategy as an independent company and remain focused on delivering

    AstraZeneca to demonstrate the strength and rapid acceleration of its oncology pipeline at ASCO 2014

    Preliminary data* released ahead of full data presentations at ASCO, 30 May-3 JuneNew data from AstraZeneca’s investigational cancer medicines demonstrate the rapid progression of its oncology pipeline. Over 40 scientific abstracts from AstraZeneca and its global biologics R&D arm MedImmune will be featured at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) at the end of this month. Data will be reported for a number of innovative molecules in different tumour types. Highlights include: · In the MEDI4736 Phase I trial to date we have seen durable clinical

    AstraZeneca to present respiratory data at ATS 2014 international conference

    Benralizumab and tralokinumab data both show improvement in key measures of asthma control for patients with specific, severe forms of asthma Data underscore strength and breadth of AstraZeneca’s respiratory pipelineAstraZeneca today announced that MedImmune, its global biologics research and development arm, will present Phase IIb data on two novel investigational molecules – benralizumab and tralokinumab – at the upcoming American Thoracic Society (ATS) 2014 International Conference being held in San Diego, California, 16-21 May. In the Phase IIb data being presented, both

    AstraZeneca issues update on strategy to deliver value to shareholders

    The Board of AstraZeneca PLC ("AstraZeneca" or "the Company") is today publishing a presentation updating on the continued progress in executing its strategy, which centres on achieving scientific leadership, strengthening its growth platforms and returning to growth. The presentation will demonstrate AstraZeneca’s excellent growth prospects, rapidly progressing pipeline and the future delivery of shareholder value as an independent company. The presentation and the contents of this announcement are based on the key sources, bases and assumptions set out at the end of this announcement.

    Amerikanska FDA godkänner Bydureon® Pen för behandling en gång i veckan av vuxna med typ 2-diabetes

    AstraZeneca meddelar idag att amerikanska Food and Drug Administration (FDA) har godkänt BYDUREON® Pen (injicerbar exenatidsuspension för långsam frisättning) på 2 mg som tillägg till diet och motion för att förbättra den glykemiska kontrollen hos vuxna med typ 2-diabetes.BYDUREON bör inte användas för behandling av patienter med typ 1-diabetes eller ketoacidos vid diabetes. BYDUREON är inte rekommenderad som förstahandsbehandling for patienter som har inadekvat glykemisk kontroll vid diet och motion. BYDUREON är inte ett substitut för insulin. Samtidig användning av BYDUREON och insulin

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