AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).
AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.
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AstraZeneca today announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic® (lesinurad). Zurampic was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.
Visar på tydlig förbättring i lungfunktion jämfört med monokomponenter och placebo
Den enda långtidsverkande dubbla luftrörsvidgaren som kommer i en dosaerosol (pMDI) och den första produkten med AstraZenecas patenterade Co-Suspension Technology
AstraZeneca meddelar idag att amerikanska Food and Drug Administration har godkänt Bevespi Aerosphere (glykopyrrolat och formoterolfumarat),en inhal
AstraZeneca och MedImmune, koncernens globala forsknings- och utvecklingsbolag för biologiska läkemedel, meddelar idag ett integrerat forskningsinititativ inom genomik som kommer att ändra vårt sätt att arbeta för att upptäcka och utveckla läkemedel tvärsöver hela forsknings- och utvecklingsportföljen
Phase I first-line Tagrisso (osimertinib) data show an objective response rate of 77%, and progression-free survival of 19.3 months in patients with EGFRm NSCLC1 Updated results in pre-treated patients with EGFR T790M mutation-positive NSCLC further support recent approvals in the US, EU and Japan
More than 60 presentations featuring 26 potential medicines across four key scientific platforms, including DNA Damage Response (DDR) and Immuno-Oncolog
Phase II/III trial of AZD3293, an oral potent small molecule BACE inhibitor, will continue to Phase III after positive interim safety data
Tagrisso™ late-breaker presentations provide updated data in first-line EGFRm and second-line EGFRm T790M lung cancer
Studies demonstrate use of blood based testing to identify patients for treatment with Iressa and Tagrisso
Data from exploratory immuno-oncology and small molecule combination studies to be presented during the conference
AstraZeneca and its global biologics research and
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the conditional approval of Pandemic Live Attenuated Influenza Vaccine (P/LAIV). P/LAIV is indicated for the prevention of influenza in an officially declared pa
First major US guideline to include expanded indication for Brilinta in patients with a heart attack beyond one year
Full approval is based on two Phase II trials, AURA extension and AURA2, demonstrating objective response rates of 61.3% and 70.9%, respectively Osimertinib targets mutation seen in significant proportion of patients with lung cancer in Japan Japanese and recent US and EU approvals for osimertinib achieved within three years of clinical trials initiation
Missed primary efficacy endpoint; fewer events observed in the Brilinta arm but trend did not reach statistical significance Consistent safety profile
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational anti-CD19 monoclonal antibody,
AstraZeneca today announced that its global biologics research and development arm, MedImmune, has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalised with Type A strain influenza. The FDA’s Fast Track programme is designed to expedite the development and review
Ltd, för rätten till Moventig (naloxegol) i EU, Island, Norge, Schweiz och Liechtenstein. Moventig är den första orala, perifert verkande my-opioidreceptor-antagonisten (PAMORA) för daglig behandling som är godkänd i Europa för behandling av opioidinducerad förstoppning (OIC) hos vuxna patienter som inte har svarat tillräckligt bra på laxermedel.
Trial didnot meet primaryendpointof improvingoverall survival in challenging to treat mesothelioma patientswith no currently approved treatmentoptions in the second-line setting Tremelimumabremainskeycomponent of Immuno-Oncologycombinationstrategy across multipletumourtypes
Agreement for Plendil in China reinforces AstraZeneca’s focus on innovative medicines
AstraZeneca and Acerta Pharma BV, a company in which AstraZeneca has a majority equity investment, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product.