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metreleptin

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Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab

The BTD is based on data from the phase 2 TRAILBLAZER-ALZ study in early symptomatic Alzheimer's patients

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AZ, HUTCHMED win first approval for MET inhibitor Orpathys in China

Continued approval in MET-positive NSCLC is contingent on the completion of a positive confirmatory trial

Biogen Idec building

Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

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Court rules on AZ and EU’s COVID-19 vaccine dispute

The Court in Brussels has ordered AZ to deliver a total of 80.2 million doses to the EU by 27 September 2021

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Pfizer/BioNTech, AZ vaccines effective against Delta COVID-19 variant after two doses

Pfizer/BioNTech and AZ vaccines found to be 96% and 92% effective against variant, respectively

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AZ’s long-acting COVID-19 antibody fails to meet primary endpoint in prevention trial

AZD7442 is based on antibodies isolated from two patients who had recovered from COVID-19

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FDA approves Biogen’s aducanumab for Alzheimer’s disease in ‘landmark’ decision

FDA is requiring Biogen to conduct a new randomised, controlled clinical trial to verify the drug’s clinical benefit for Alzheimer’s patients

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AZ appoints Alexion’s Aradhana Sarin as chief financial officer

Sarin will become AZ's new chief financial officer upon closing of the company’s acquisition of Alexion Pharmaceuticals

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Positive results for AZ, Merck & Co’s Lynparza in early breast cancer presented at ASCO

Lynparza reduced the risk of invasive breast cancer recurrence, second cancers or death by 42% in the overall trial population

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Moderna seeks full FDA approval for its COVID-19 vaccine

Moderna's mRNA-based vaccine is currently authorised for emergency use in the US

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BMS’ Zeposia gains FDA approval in ulcerative colitis

Treatment was initially approved in 2020 for multiple sclerosis

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AZ’s Tagrisso approved for EGFR-positive NSCLC in the EU

European Commission approved Tagrisso in this setting based on positive results from the ADAURA phase 3 study

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