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Peter Impey

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Product launches: making the most of your one shot

While some errors are unforeseen, many can be prevented with better planning, coordination, communication and transparency in launch planning and implementation

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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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Novo Nordisk partners with Heartseed on heart failure cell therapy

Heartseed is eligible to receive up to a total $598m as part of the collaboration and licence agreement

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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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First NHS patient treated with Novartis’ SMA gene therapy Zolgensma

Novartis and NHS England reached a landmark deal for the gene therapy earlier this year

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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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Cross functions

The biggest problem in your company is also your biggest opportunity

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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

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