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- PMLiVE

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Roche Basel Switzerland

Roche’s flu pill Xofluza moves closer towards EU approval

CHMP recommends drug for approval in the EU

- PMLiVE

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

Committee reiterated previous negative opinion

- 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

- 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

EU flag

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

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