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- PMLiVE

Clinical Trials Directive

- 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

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

- PMLiVE

Policy and public health: all the decisions we can’t see

January was a bad month for healthcare in China

- PMLiVE

Givlaari, Rybelsus lead crowded CHMP recommendations

EU regulator delivered 15 positive opinions and no rejections

- 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

- PMLiVE

Novartis’ Mayzent and Roche’s Polivy lead CHMP recommendations

Sanofi Genzyme’s Lemtrada and Pfizer's Xeljanz receive label restrictions

- PMLiVE

Provention Bio wins PRIME designation for type 1 diabetes prevention drug

Meanwhile J&J partnered Crohn's drug flops in phase 2

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