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JAK inhibitors

- PMLiVE

EMA recommends new manufacturing sites for COVID-19 vaccines

EMA also recommends new storage temperature for Pfizer/BioNTech vaccine

- PMLiVE

EMA updates product information for AZ COVID-19 vaccine

PRAC reaffirms opinion that AZ vaccine's efficacy outweighs very rare likelihood of developing a blood clotting disorder

- PMLiVE

EMA review confirms AZ/Oxford’s COVID-19 vaccine is safe and effective

EU regulator said that the vaccine is not associated with an increase in the overall risk of blood clots

- PMLiVE

Benefits of AZ COVID-19 vaccine ‘continue’ to outweigh risks, says EMA’s executive director

EU regulator is expected to publish findings from its investigation on Thursday

- PMLiVE

EMA says there is ‘no indication’ AZ/Oxford’s COVID-19 vaccine causes blood clots

Agency’s safety committee added vaccine’s benefits continue to outweigh risks

- PMLiVE

J&J applies for EU authorisation for one-dose COVID-19 vaccine

Submission is based on top-line efficacy and safety data from the phase 3 ENSEMBLE trial

- PMLiVE

EU to begin new study programme investigating COVID-19 variants

Programme is expected to launch on Wednesday

Roche Basel Switzerland

Roche’s flu pill Xofluza gains EU approval

EU approval is based on results from three phase 3 studies

- PMLiVE

EMA recommends authorisation of Moderna’s COVID-19 vaccine

European Commission likely to formally approve the vaccine soon

- PMLiVE

EMA launches rolling review of J&J’s COVID-19 vaccine

Vaccine entered phase 3 testing in September

- PMLiVE

Sobi’s Gamifant receives final rejection from CHMP for primary HLH

Committee reiterated previous negative opinion

- PMLiVE

EMA will assess potential COVID-19 vaccine on ‘case by case’ basis

Agency will not specify a minimum level of efficacy, according to Reuters

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