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- PMLiVE

Bad news for Portola as CHMP considers Factor Xa drugs

The committee are ‘unlikely’ to adopt a positive opinion for betrixaban

- PMLiVE

EMA’s Amsterdam home will not be ready in time

Staff will initially move to a temporary building in the city after Brexit

- PMLiVE

CHMP hands Santhera second ‘no’ in Duchenne muscular dystrophy

Swiss biopharma says it will re-file Raxone for the licence extension

- PMLiVE

EMA hands UniQure orphan status first in Huntington’s

The Dutch biotech expects to file the treatment for approval later this year

Sanofi reception

Third time lucky? Sanofi cuts an $11.6bn deal to buy Bioverativ

French pharma firm offers $105 apiece for the spin-out’s shares

- PMLiVE

Novartis gets speedy reviews for new Kymriah filings

US and EU regulatory agencies will review the drug for DLBCL patients

- PMLiVE

Shire separates out neuroscience as it considers its future

Follows last year's strategic review at the Irish biotechnology firm

AstraZeneca AZ

AZ speeds first-line lung cancer filing for Tagrisso to EMA

As FLAURA trial results show boosted progression-free survival

- PMLiVE

EMA forges closer ties with HTA umbrella group

Agrees joint work plan with the European Network for Health Technology Assessment

- PMLiVE

Amsterdam picked to host the European Medicines Agency

But regulator faces a “challenging” relocation project to depart from London

Magic of Lucid targets rare and specialist diseases

Lucid Group, the award-winning global medical communications company with offices in London, Buckinghamshire, Macclesfield and New York, has announced the launch of a new agency specialising in rare and specialist...

Lucid Group Communications Limited

- PMLiVE

Merck pulls Keytruda filing in Europe, despite US approval

Phase II KeyNote-0241 trial results failed to win over the EMA

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