AstraZeneca divests rights for Losec to Cheplapharm
AstraZeneca has agreed to sell the global commercial rights, excluding China, Japan, the US and Mexico, for Losec (omeprazole) and associated brands to Cheplapharm Arzneimittel GmbH (Cheplapharm).
Ämnen: Farmaci
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Update on US regulatory review of PT010 in COPD
AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD).
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Lynparza more than doubled the time without radiographic disease progression in patients with BRCA1/2- or ATM-mutated metastatic castration-resistant prostate cancer
AstraZeneca and MSD Inc., Kenilworth, N.J., US today presented detailed results from the Phase III PROfound trial in 387 men with metastatic castration-resistant prostate cancer (mCRPC) who have a mutation in their homologous recombination repair (HRRm) genes and whose disease had progressed on prior treatment with new hormonal agent (NHA) treatments (e.g. abiraterone or enzalutamide).
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Tagrisso is the only 1st-line treatment for EGFR-mutated non-small cell lung cancer to deliver a median overall survival of more than three
AstraZeneca today presented detailed overall survival (OS) results from the Phase III FLAURA trial of Tagrisso (osimertinib) in the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
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Lynparza improved the time women lived without disease progression to 22 months in the broad population and to 37 months in HRD-positive patients as 1st-line maintenance treatment with bevacizumab for newly-diagnosed advanced ovarian cancer
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced detailed positive results from the Phase III PAOLA-1 trial, showing Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in women with newly-diagnosed advanced ovarian cancer.
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AstraZeneca to present next wave of science in respiratory disease at ERS International Congress
AstraZeneca will present new data on its portfolio of inhaled combination and biologic therapies, and pipeline of emerging medicines at the European Respiratory Society (ERS) International Congress, which takes place from 28 September to 2 October in Madrid, Spain. The breadth and depth of science is reflected in the 65 abstracts accepted, including 17 oral presentations.
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AstraZeneca inleder unikt samarbete kring analystekniken DNP-NMR
AstraZeneca har tecknat ett samarbetsavtal med Göteborgs universitet kring den avancerade analystekniken ”Dynamic Nuclear Polarization” (DNP-NMR). Syftet med samarbetet, där de båda avtalsparterna gemensamt investerar i ett så kallat DNP-NMR instrument, är att korta utvecklingstiden och ytterligare förbättra kvalitén på nya läkemedel.
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Qtrilmet recommended for approval in EU by CHMP for the treatment of type-2 diabetes
AstraZeneca today announced that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union for the treatment of adults with type-2 diabetes (T2D).
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AstraZeneca amends collaboration with Ironwood for Linzess in China
AstraZeneca has amended its collaboration agreement with Ironwood Pharmaceuticals, Inc. (Ironwood) in China mainland, China Hong Kong and China Macau for Linzess* (linaclotide), a first-in-class new treatment for patients with irritable bowel syndrome with constipation (IBS-C).
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AstraZeneca redefines cancer treatment with practice-changing data at ESMO 2019
AstraZeneca will unveil a series of breakthrough data across multiple cancer types in its mission to one day eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, 27 September to 1 October 2019.
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FDA grants Fast Track designation for Farxiga in heart failure
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).
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Imfinzi is first immunotherapy to show both significant survival benefit and improved, durable responses in extensive-stage small cell lung cancer
AstraZeneca today presented detailed results from the Phase III CASPIAN trial, showing Imfinzi (durvalumab) significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC).
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Tagrisso approved in China as a 1st-line treatment for EGFR-mutated non-small cell lung cancer
AstraZeneca today announced that it has received marketing authorisation from China’s National Medical Products Administration for Tagrisso (osimertinib) as a 1st-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions.
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Brilinta reduced the risk of cardiovascular events in patients with coronary artery disease and type-2 diabetes in Phase III THEMIS trial
AstraZeneca today announced detailed results from the positive Phase III THEMIS trial which showed Brilinta (ticagrelor) plus aspirin reduced the relative risk for the composite of cardiovascular (CV) death, heart attack, or stroke by 10% compared with aspirin alone, a statistically significant reduction.
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Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure
AstraZeneca today announced detailed results from the landmark Phase III DAPA-HF trial that showed Farxiga (dapagliflozin) on top of standard of care reduced both the incidence of cardiovascular death and the worsening of heart failure.
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AstraZeneca to present data at ESC Congress 2019 that potentially redefines the treatment of heart failure
AstraZeneca will present results from the Farxiga (dapagliflozin) Phase III DAPA-HF trial at the ESC Congress in Paris, making Farxiga the first medicine in its class to move into a new disease area by demonstrating efficacy and safety data for the treatment of patients with heart failure.
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Anifrolumab Phase III trial meets primary endpoint in systemic lupus erythematosus
straZeneca today announced that the Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care.
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Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis (EoE).
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Breztri Aerosphere Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease
AstraZeneca today announced positive results from the Phase III ETHOS trialfor triple-combination therapy Breztri Aerosphere, formerly PT010, in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
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FDA grants Fast Track designation for Farxiga in chronic kidney disease
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD).
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