Forxiga approved in Japan for type-1 diabetes
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).
Ämnen: Medicin, läkemedel
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Forxiga approved in Europe for type-1 diabetes
The European Commission (EC) has approved Forxiga (dapagliflozin) for use in type-1 diabetes (T1D) as an adjunct to insulin in patients with a BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. This is the first approval of Forxiga for the treatment of patients with T1D
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First sub-analyses from the DECLARE-TIMI 58 trial further support the cardiovascular effects of Farxiga in type-2 diabetes
Positive results from a pre-specified sub-analysis of the Phase III DECLARE-TIMI 58 trial showed that Farxiga (dapagliflozin) reduced the relative risk of major adverse cardiovascular events (MACE) by 16% compared to placebo in patients with type-2 diabetes (T2D) who had a prior heart attack (myocardial infarction).
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US FDA grants saracatinib Orphan Drug Designation for idiopathic pulmonary fibrosis
The US Food and Drug Administration has granted Orphan Drug Designation for saracatinib, a potential new medicine for the treatment of IPF, a type of lung disease that results in scarring (fibrosis) of the lungs. Saracatinib is an inhibitor of src kinase which regulates broad cell functions including cell growth and cell differentiation.1 Saracatinib has completed Phase I development.
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AstraZeneca showcases next-generation Oncology pipeline addressing unmet patient needs at AACR Annual Meeting
AstraZeneca will share pioneering research and development across its successful Oncology portfolio and extensive next-generation pipeline at the American Association for Cancer Research (AACR) Annual Meeting in Atlanta, USA, 29 March to 3 April 2019.
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AstraZeneca to present new cardiovascular data on Farxiga in type-2 diabetes at ACC 2019
First sub-analyses from Phase III DECLARE-TIMI 58 trial selected for late-breaking clinical trial and oral presentations. Data evaluating the CV effects of Farxiga, including hospitalisation for heart failure in adults with type-2 diabetes have been selected for late-breaking clinical trial and oral presentations at the American College of Cardiology’s on 16-18 March.
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Lynparza receives positive EU CHMP opinion for use in germline BRCA-mutated HER2-negative advanced breast cancer
AstraZeneca and MSD, Inc. today announced that the CHMP of the European Medicines Agency has adopted a positive opinion, recommending the use of Lynparza (olaparib) tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
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Lynparza significantly delayed disease progression as 1st-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced positive results from the Phase III POLO trial. Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Lynparza (olaparib) vs. placebo.
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Brilinta’s Phase III THEMIS trial met primary endpoint in patients with established coronary artery disease and type-2 diabetes
The Phase III THEMIS trial met its primary endpoint and demonstrated that Brilinta (ticagrelor), taken in conjunction with aspirin, showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE) compared to aspirin alone.
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AstraZeneca PLC:s resultatrapport för helåret och fjärde kvartalet 2018
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.
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US FDA grants Fasenra Orphan Drug Designation for hypereosinophilic syndrome
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.
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US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897
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.
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EMA grants PRIME eligibility for potential next-generation RSV medicine MEDI8897
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.
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Forxiga receives positive EU CHMP opinion for the treatment of adults with type-1 diabetes
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 -
Linzess (linaclotide) approved in China for the treatment of irritable bowel syndrome with constipation
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)
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AstraZeneca tillkännager organisationsförändringar
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.
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Bevespi Aerosphere approved in the EU for chronic obstructive pulmonary disease
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).
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Lynparza meets primary endpoint in Phase III SOLO-3 trial for the treatment of relapsed BRCA-mutated advanced ovarian cancer
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
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Phase III OLYMPUS and ROCKIES trials for roxadustat met their primary endpoints in chronic kidney disease patients with anaemia
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.
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Lynparza approved by US FDA for 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer
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.....
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