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Clinical Trials Directive

- 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

- PMLiVE

EMA begins rolling review of CureVac’s COVID-19 vaccine

Investigational vaccine is currently being evaluated in a phase 2/3b clinical trial

regeneron headquarters

EMA launches rolling review of Regeneron’s COVID-19 antibody cocktail

Study suggests REGN-COV2 can reduce viral load in non-hospitalised patients with COVID-19

- PMLiVE

CHMP recommends EU approval for Amarin’s cardiovascular risk reduction drug

The drug is recommended for use in adult patients who are already receiving statin treatment

- PMLiVE

New dosing option for AZ’s Imfinzi approved in the EU and UK

Additional option extends dosing from two weeks to four weeks

- PMLiVE

AZ seeks EU approval for its Oxford University-partnered COVID-19 vaccine

CHMP could reach a decision on opinion by 29 January

Roche Basel Switzerland

Roche’s flu pill Xofluza moves closer towards EU approval

CHMP recommends drug for approval in the EU

- PMLiVE

Novartis scores CHMP backing for cholesterol drug Leqvio

Potential first-in-class treatment moves closer to EU approval

- PMLiVE

Pfizer and BioNTech’s COVID-19 vaccine begins EMA evaluation

Vaccine is the second to undergo EMA's 'rolling review' process after AstraZeneca/Oxford Uni's candidate

- PMLiVE

EMA begins rolling review of AZ’s COVID-19 vaccine candidate

Agency has started evaluating data from non-clinical laboratory studies

- PMLiVE

EMA accepts application for bluebird bio’s Lenti-D in CALD

Gene therapy could become a potentially transformative treatment for cerebral adrenoleukodystrophy

- PMLiVE

GSK’s anti-BCMA drug leads crowded CHMP recommendations

Ten new drugs receive positive recommendations for approval

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