AstraZeneca PLC:s resultatrapport för första kvartalet 2017
En positiv start med fortsatt nyhetsflöde kring vår forskningsportfölj i det som har potential att bli ett avgörande år för bolaget
Ämnen: Farmaci
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Tagrisso receives full approval in the EU
Full approval follows Tagrisso’s expedited Conditional Marketing Authorisation as first-in-class medicine for patients with locally-advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer
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Tagrisso (osimertinib) receives US FDA full approval
Conversion from accelerated to full approval confirms the potential of Tagrissoto become standard of care in the US Approval based on Phase III AURA3 trial thatdemonstrated significant improvement in progression-free survival with Tagrisso as compared to chemotherapy
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AstraZeneca’s potential medicine for Neuromyelitis Optica Spectrum Disorder receives orphan designation in Europe
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Medicines Agency (EMA) has granted orphan designation to inebilizumab (formerly MEDI-551) for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
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AstraZeneca to share its robust early science in Oncology with the medical community at AACR 2017
60 abstracts from early oncology portfolio including 7 oral presentations, across Tumour Drivers and Resistance, Immuno-Oncology, Antibody-Drug Conjugates and DNA Damage Response Potential new medicines targeting cancer cell-death mechanisms highlight potential of emerging Tumour Drivers and Resistance research
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Tagrisso approved in China as first-in-class treatment for EGFR T790M mutation-positive metastatic non-small cell lung cancer
First AstraZeneca medicine approved under China’s new Priority Review pathway Tagrisso is an important new medicine in a country where lung cancer is the leading cause of cancer-related deaths and EGFR-mutation rates are among highest globally
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AstraZenecas observationsstudie CVD-REAL visar att SGLT-2-hämmare signifikant minskade antalet sjukhusinläggningar på grund av hjärtsvikt och antalet dödsfall jämfört med andra läkemedel vid diabetes typ 2
Banbrytande data från en internationell observationsstudie av över 300 000 patienter med typ-2 diabetes visar att behandling med SGLT-2-hämmare minskade risken för sjukhusinläggning på grund av hjärtsvikt med 39% och den totala mortaliteten med 51%.
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AstraZeneca and Circassia enter strategic collaboration in respiratory disease
Circassia will lead promotion of Tudorza and prepare for potential launch of Duaklir in the US Strategic collaboration further sharpens AstraZeneca’s respiratory focus on Symbicort, Bevespi Aerosphere, benralizumab and other development programmes
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AstraZeneca receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia
AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate).
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Fas III-studien SOLO-2 visar på förlängd progressionsfri överlevnad med Lynparza som underhållsbehandling av BRCA-muterad äggstockscancer
Lynparza minskade risken för sjukdomsprogression med 70 %, med en prövarbedömd progressionsfri överlevnad på 19,1 månader, jämfört med 5,5 månader för placebo En blindad, oberoende central granskning visade en progressionsfri överlevnad på 30,2 månader, jämfört med 5,5 månader för placebo
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Medimmune and Sanofi Pasteur form alliance to develop and commercialise potential next-generation respiratory syncytial virus antibody MEDI8897
MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, today announced an agreement to develop and commercialise MEDI8897 jointly.
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FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type-2 diabetes
Qtern fixed-dose combination will provide an additional oral medicine option for patients taking Farxiga (dapagliflozin) to improve blood sugar level
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AstraZeneca enters agreement with TerSera Therapeutics for Zoladex in the US and Canada
AstraZeneca to receive upfront payment and sustainable and ongoingsales-based income Agreement expands the commercial potential of Zoladex in US and Canada
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Updated durvalumab monotherapy data confirm results in urothelial bladder cancer
Updated Study 1108 data presented at ASCO GU demonstrate compelling clinical activity in patients that had previously progressed during or after one line of standard platinum-based chemotherapy
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Lynparza meets primary endpoint in phase III trial in BRCA-mutated metastatic breast cancer
Lynparza provided a statistically-significant improvement in progression-free survival compared to chemotherapy First positive randomised trial to evaluate the efficacy and safety of a PARP inhibitor beyond ovarian cancer
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Siliq (brodalumab) approved by the US FDA for adult patients with moderate-to-severe plaque psoriasis
Approval triggers $130 million milestone payment to AstraZeneca from US Partner Valeant Pharmaceuticals
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AstraZeneca leder nytt industriforskningscentrum för utveckling av målsökande biologiska läkemedel
Stiftelsen för strategisk forskning (SSF) satsar minst 75 miljoner kronor i ett AstraZeneca-samarbete om att paketera biologiska läkemedel i nanokapslar för att nå in i kroppens celler och bota svåra sjukdomar.
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AstraZeneca PLC:s resultatrapport för helåret och fjärde kvartalet 2016
Resultatet är i linje med våra förväntningar; 2017 har potential att bli ett avgörande år
Ekonomisk sammanfattning
En utdelning för andra halvåret på 1,90 USD per aktie har tillkännagivits, vilket ger en utdelning för helåret på 2,80 USD per aktie. Styrelsen bekräftar på nytt sitt stöd för bolagets progressiva utdelningspolicyNedgången i produktförsäljningen speglade huvudsakligen introduk -
Symbicort granted paediatric exclusivity in the US
AstraZeneca today announced that on 25 January 2017 the US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol.
The FDA’s decision was based on the evaluation of trials conducted in children with asthma aged six up to 12 years in response to a Written Request (a prerequisite for qualifying for paediatric exclus -
AstraZeneca expands 1st-line lung cancer immuno-oncology programme opportunities
Refined endpoints and statistical analysis plan in the Phase III MYSTIC trial China regulatory submission opportunity strengthened with the expansion of the Phase III NEPTUNE trial and the initiation of the new Asia-focused Phase III PEARL trial
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