Nya lanseringar och det kommersiella genomförandet ger en tillväxt i produktförsäljningen för helåret och ett mycket starkt sista kvartal. 2019 förväntas bli ett år med högre tillväxt i produktförsäljningen jämfört med föregående år, kombinerat med en operativ hävstångseffekt.
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of hypereosinophilic syndrome (HES). HES is a group of rare, potentially fatal disorders characterised by high numbers of eosinophils in blood and tissues, which can cause progressive damage to any organ in the body.
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Medicines Agency (EMA) has granted access to its PRIME (PRIority MEdicines) scheme for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.
Forxiga is the first oral medicine recommended for approval in Europe as an adjunct treatment to insulin for adults with type-1 diabetes
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new indication for the marketing authorisation of Forxiga (dapagliflozin), after adopting a positive opinion for use as an oral adjunct treatment
AstraZeneca today announced that its partner Ironwood Pharmaceuticals, Inc. has received marketing authorisation from the National Medical Products Administration (NMPA) for Linzess (linaclotide) in China for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C)
AstraZeneca meddelar idag organisationsförändringar för att stödja fortsatt vetenskaplig innovation och kommersiell framgång inom de huvudsakliga terapiområdena, i samband med att bolaget går in i en ny fas i dess strategiska utveckling. Som en del av förändringarna meddelas att den mycket erkända onkologiforskaren José Baselga också rekryterats.
AstraZeneca today announced that the European Commission (EC) has approved Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
AstraZeneca and MSD’s Lynparza significantly improved objective response rate compared to chemotherapy in platinum-sensitive relapsed patients who had two or more prior lines of chemotherapy
AstraZeneca today announced that the Phase III OLYMPUS and ROCKIES trials for roxadustat each met their primary efficacy endpoints for the treatment of patients with anaemia in chronic kidney disease (CKD) that are either non-dialysis-dependent or dialysis-dependent, respectively.
AstraZeneca and Merck & Co. US today announced that the FDA has approved Lynparza for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.....
AstraZeneca today announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. has now received formal marketing authorisation from the National Medical Products Administration for roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor and new oral treatment for patients with anaemia caused by chronic kidney disease that are on dialysis.
AstraZeneca today announced a new collaboration with Cancer Research UK to launch a centre of excellence in genetic screening, cancer modelling and big data processing aimed at accelerating the discovery of new cancer medicines.
AstraZeneca and MedImmune today announced overall survival results for the Phase III EAGLE trial. EAGLE is a randomised, open-label, multi-centre trial evaluating Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus standard-of-care chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma......
AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, have presented new, long-term follow-up results for Calquence (acalabrutinib) in patients with relapsed or refractory mantle cell lymphoma (MCL).
NT-rådets (Rådet för nya terapier) rekommendation till landstingen är att Imfinzi (durvalumab) kan införas som ett behandlingsalternativ vid icke småcellig lungcancer (NSCLC). Beslutet innebär att NT rådet ser ett visst värde i behandlingsalternativet men låter landsting och regioner själva avgöra i vilken mån det ska införas som ett behandlingsalternativ.
AstraZeneca, together with Acerta Pharma, its haematology research and development centre of excellence, and MedImmune, its global biologics research and development arm, will present 27 abstracts, including six oral presentations, at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, USA, December 1-4.
AstraZeneca today announced that the US Food and Drug Administration has granted Orphan Drug Designation for Fasenra (benralizumab) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).
AstraZeneca and MedImmune, today announced final overall survival results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy and the combination of Imfinzi and tremelimumab, an anti-CTLA4 antibody, versus standard-of-care platinum-based chemotherapy in previously-untreated patients with Stage IV (metastatic)NSCLC.
AstraZeneca has agreed to sell US rights to Synagis(palivizumab) used for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) to Swedish Orphan Biovitrum AB (publ) (Sobi). Sobi will commercialise Synagis in the US and around 130 AstraZeneca employees will transfer to Sobi as part of the transaction.