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- PMLiVE

LentiGlobin

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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

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EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

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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

- PMLiVE

EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine

Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets

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bluebird bio anticipates lift of clinical holds on LentiGlobin in mid-2021

Previously reported case of MDS in phase 1/2 study has been re-classified as transfusion-dependent anaemia

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J&J delays EU COVID-19 vaccine rollout following pause in the US

FDA and CDC recommended pausing rollout in US after reported cases of rare blood clots in vaccinated individuals

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New restrictions for AZ/Oxford COVID-19 vaccine despite EMA endorsement

Regulators in Canada and Germany have reportedly placed new restrictions on vaccine

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EMA recommends new manufacturing sites for COVID-19 vaccines

EMA also recommends new storage temperature for Pfizer/BioNTech vaccine

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BMS and bluebird bio gain FDA approval for multiple myeloma therapy

Abecma is a CAR T cell therapy approved for pre-treated myeloma patients

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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

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