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- PMLiVE

Sivextro

- PMLiVE

ViiV’s two-drug HIV combo backed by CHMP

The committee also backs two biosimilar medicines

- PMLiVE

EMA starts review of Xtandi in non-metastatic prostate cancer

The evaluation is based on positive results from the PROSPER trial

- PMLiVE

Bad news for Portola as CHMP considers Factor Xa drugs

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

- PMLiVE

Allergan’s Avycaz breaks Gram-negative pneumonia antibiotic drought

Becomes the first new drug to treat the condition in over 15 years

- 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

Pharma must do more on antibiotic resistance, Davos meeting hears

But AMR report acknowledges the industry is doing 'better than expected'

- PMLiVE

EMA hands UniQure orphan status first in Huntington’s

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

Can Cinderella save us?

AMR research ‘under threat’ due to lack of economic incentives

But industry report also shows progress made by the private sector

- PMLiVE

Novartis gets speedy reviews for new Kymriah filings

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

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

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