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.
Godkännande av en ny dos på 60 mg utvidgar den nuvarande indikationen till att även omfatta långsiktig behandling ett år efter tidigare hjärtinfarkt
AstraZeneca today announced that the European Commission (EC) has granted marketing authorisation for ZurampicTM(lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid (sUA) levels with an adequate dose of an XOI alone.
Zurampic is a sele
