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- PMLiVE

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Biogen Idec building

Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

- PMLiVE

BMS and Eisai to collaborate in deal worth up to $3.1bn

The two companies will work on developing a drug for endometrial, ovarian, lung and breast cancers

- PMLiVE

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

- PMLiVE

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

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

- PMLiVE

European Commission approves Opdivo plus Cambometyx for advanced kidney cancer

Checkpoint inhibitor plus tyrosine kinase inhibitor approved for the first-line treatment of advanced renal cell carcinoma

- 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

- PMLiVE

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

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

- PMLiVE

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

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

- PMLiVE

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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