AstraZeneca PLC:s resultatrapport för första kvartalet 2019
Den positiva försäljningsutvecklingen fortsätter och den operativa hävstångseffekten bidrog till vinsttillväxten
Ämnen: Industri, tillverkning
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Lynparza approved in EU for the treatment of germline BRCA-mutated HER2-negative advanced breast cancer
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced the European Commission has approved Lynparza (olaparib)as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer.
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Positive results from Fasenra Phase II trial in hypereosinophilic syndrome published in New England Journal of Medicine
A Phase II trial has demonstrated that Fasenra (benralizumab) can achieve near-complete depletion of eosinophils and improve clinical outcomes in hypereosinophilic syndrome (HES). The results are published in the New England Journal of Medicine.
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Selumetinib granted US Breakthrough Therapy Designation in neurofibromatosis type 1
AstraZeneca and MSD, Inc., today announced that the US FDA has granted Breakthrough Therapy Designation for the MEK 1/2 inhibitor and potential new medicine selumetinib. This designation is for the treatment of paediatric patients aged three years and older with neurofibromatosis type 1 symptomatic and/or progressive, inoperable plexiform neurofibromas (PN), a rare, incurable genetic condition.
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Proposed placing of new ordinary shares
This announcement contains inside information THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY JURISDICTION IN WHICH THE SAME WOULD BE UNLAWFUL L
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AstraZeneca and Daiichi Sankyo enter collaboration for novel HER2-targeting antibody-drug conjugate
This announcement contains inside information The securities proposed to be offered pursuant to the equity placing referred to herein will not be and have not been registered under the US Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
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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).
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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
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