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Janet Woodcock

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G7 expected to donate one billion COVID-19 vaccine doses

At the same time, the FDA has extended the shelf-life of the single-dose J&J vaccine

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US to donate 500 million Pfizer/BioNTech COVID-19 vaccine doses through COVAX

As part of the agreement, 500 million doses will be delivered between August 2021 and June 2022

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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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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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Israel finds a ‘probable link’ between Pfizer vaccine and myocarditis cases

Reported cases increased following the second dose of the mRNA-based COVID-19 vaccine

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Sinovac’s COVID-19 vaccine receives WHO emergency use listing

Vaccine found to be 51% effective in preventing symptomatic disease, meeting the WHO's recommendation of at least 50% efficacy

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J&J’s single-dose COVID-19 vaccine secures approval from the UK’s MHRA

Vaccine was found to be 67% effective in preventing COVID-19 infection in a phase 3 study

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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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EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15

Clinical trial data recently showed that the vaccine is safe and effective in individuals in this age group

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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

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GSK, Vir’s COVID-19 mAb scores FDA emergency use approval

Interim phase 3 trial results found sotrovimab reduced the risk of hospitalisation or death by 85% compared to placebo

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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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