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bluebird bio’s CALD gene therapy Skysona gains positive opinion from CHMP

CHMP's marketing authorisation recommendation is a step towards gaining EU approval

- PMLiVE

bluebird bio aiming to separate business units by year-end

Biotech company has revealed that its new, separate oncology company will be named 2seventy bio

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Novavax is close to finalising a COVID-19 vaccine supply deal with the EU

Reuters reported that the company is planning to send doses to Europe before the end of the year

EU cross-border healthcare

The clock is ticking to improve access to gene and cell therapies for rare diseases

- PMLiVE

J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

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EMA begins accelerated review of Gilead’s Trodelvy for triple-negative breast cancer

FDA approved the antibody-drug conjugate in this indication in April 2020

- PMLiVE

EU leaders debate COVID-19 vaccine export measures during virtual summit

AstraZeneca urged to ‘honour’ contract with EU before exporting doses elsewhere

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Fishawack Health unveils an unrivaled global market access and HEOR offering with the acquisition of PRMA Consulting

Fishawack Health bolsters its strong strategic offering by acquiring PRMA Consulting – a global market access and HEOR consulting leader with significant expertise in US, EU, and Asia-Pacific markets

Avalere Health

- PMLiVE

J&J’s one-dose COVID-19 vaccine granted EU authorisation

Company aiming to begin vaccine delivery to EU in the second half of April

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EMA starts rolling review of Lilly’s COVID-19 antibodies

CHMP will review the combination of bamlanivimab and etesemivab as well as bamlanivimab monotherapy

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EMA recommends use of Lilly’s COVID-19 antibody cocktail

Agency concludes bamlanivimab and etesevimab can be used to treat certain COVID-19 patients

- PMLiVE

EMA begins rolling review process for Sputnik V COVID-19 vaccine

Late-stage trial results found vaccine gives 91.6% protection against COVID-19

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