AstraZeneca has agreed to sell U.S. rights to Synagis (palivizumab) used for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) to Swedish Orphan Biovitrum AB (Sobi). Sobi will commercialize Synagis in the U.S. and around 130 AstraZeneca employees will transfer to Sobi as part of the transaction. Sobi will also have the right…
CHMP Backs Clearance Of AstraZeneca’s Tagrisso
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a change to the terms of the Marketing Authorisation for Tagrisso (osimertinib) to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR)…
CDC Committee Says AstraZeneca’s FluMist Vaccine OK For 2018-2019 Season
AstraZeneca announces renewed recommendation and availability of FluMist Quadrivalent vaccine in the U.S. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has voted in favor of a renewed recommendation for the use of AstraZeneca’s FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) in the U.S. for the 2018-2019 season. The…
AstraZeneca’s Imfinzi Receives Breakthrough Therapy Designation
Imfinzi granted Breakthrough Therapy designation by U.S. FDA for patients with locally-advanced unresectable non-small cell lung cancer. AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer…