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- PMLiVE

Onglyza

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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

- PMLiVE

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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Eli Lilly demonstrates Verzenio win in high-risk breast cancer subset at ASCO

Verzenio plus endocrine therapy reduced the risk of patients developing metastatic disease by 39%

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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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FDA panel backs Provention Bio’s type 1 prevention drug teplizumab

Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) narrowly voted in favour of supporting approval of the drug

- PMLiVE

EU takes legal steps against AZ over delayed COVID-19 vaccine deliveries

Lawyers for the European Commission have asked the court to fine AZ €10m per infraction

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FDA priority review granted for J&J, Legend Biotech’s myeloma CAR T therapy

CAR T therapy demonstrated an overall response rate of 97% in relapsed/refractory multiple myeloma patients after 12.4 months

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UK’s Competition and Markets Authority to review AZ/Alexion merger

Proposed acquisition has already received competitions clearance in the US and Canada

- PMLiVE

AZ, Pfizer/BioNTech COVID-19 vaccines ‘highly effective’ against Indian variant

UK study finds vaccines are likely to be effective in preventing hospitalisation/death

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