Agreement - January 3, 2022
AstraZeneca and Ionis close agreement
AstraZeneca has closed a global development and commercialization agreement with Ionis Pharmaceuticals for eplontersen, formerly known as IONIS-TTR-LRX. The companies will jointly develop and commercialize eplontersen in the US, while AstraZeneca will develop and commercialize it in the rest of the world, except in Latin America. Financial considerations Under the terms of the agreement, the […]
Pharma Business - December 22, 2021
AstraZeneca’s Ultomiris accepted for FDA Priority Review
The supplemental Biologics License Application (sBLA) for Ultomiris (ravulizumab-cwvz) in adults with generalised myasthenia gravis (gMG) has been accepted for Priority Review by the US Food and Drug Administration (FDA). The FDA set a Prescription Drug User Fee Act date during the second quarter of 2022, following use of a rare disease priority review voucher by Alexion, […]
Pharma Business - December 21, 2021
Saphnelo recommended for approval in the EU
AstraZeneca’s Saphnelo has been recommended for marketing authorization in the European Union (EU) as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy. If approved, Saphnelo would be the first new treatment for SLE in Europe in more than a decade, […]
Pharma Business - December 20, 2021
Sweden Biomanufacturing Center has been inaugurated
AstraZeneca’s new facility for the production of next generation biologics will create almost 900 new jobs. Sweden Biomanufacturing Center (SBC) is located in Södertälje. “It is no coincidence that we have chosen to launch this production site in Sweden. Sweden is in many ways attractive and we will continue to invest here, given Sweden’s strong […]
New Market - December 20, 2021
AstraZeneca’s Tezspire approved in the US
AstraZeneca and Amgen’s Tezspire has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma. Tezspire was approved following a Priority Reviewby the US Food and Drug Administration (FDA) and based on results from the PATHFINDER clinical trial programme. The application included […]
COVID-19 - December 13, 2021
AstraZeneca’s new COVID-19 drug to be manufactured in Sweden
The last manufacturing steps of the company’s Evusheld (previously AZD7442) will take place in Södertälje, Sweden. Packaging and release of the potential new drug, a combination of long-acting antibodies that both prevent and treat COVID-19, has already begun in Södertälje – AstraZeneca’s largest facility within its global production network. The plan is to increase production […]
