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- PMLiVE

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- 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

- PMLiVE

EMA to support real-world monitoring of COVID-19 treatments/vaccines

New infrastructure will support real-world studies

- PMLiVE

In virtual meeting, CHMP backs Sanofi’s myeloma drug Sarclisa

Monthly meeting held remotely for the first time due to COVID-19 pandemic

- PMLiVE

EMA calls for pooled EU research into COVID-19 therapies

Asks for a harmonised methodology across member states

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EMA to consider coronavirus’ impact on EU medicines supply

Steering group will identify EU-wide actions to mitigate medicine supply risks

- PMLiVE

Modest meeting sees only two drugs recommended by CHMP

Lilly’s migraine med Emgality receives negative opinion for label extension

- PMLiVE

Givlaari, Rybelsus lead crowded CHMP recommendations

EU regulator delivered 15 positive opinions and no rejections

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Another blow for BMS in first-line NSCLC as it pulls EU filing

Opdivo/Yervoy combination is still under review with the FDA

- PMLiVE

It’s Brexit day – now comes the really hard stuff

Months of trade negotiations between UK and EU lie ahead

Roche Basel Switzerland

EMA backs adjuvant use of Roche’s breast cancer ADC Kadcyla

Could face tough competition soon from a number of rivals

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