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EMA starts rapid review of Shire’s HAE antibody

The EU medicines regulator is expected to make a verdict in 150 days

- PMLiVE

ViiV’s two-drug HIV combo backed by CHMP

The committee also backs two biosimilar medicines

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EMA starts review of Xtandi in non-metastatic prostate cancer

The evaluation is based on positive results from the PROSPER trial

Sanofi reception

Sanofi, Regeneron offer price cut for cholesterol drug Praluent

Amgen’s Repatha also struggled to secure reimbursement at its launch price point

Working with our healthcare system more closely is vital

Bayer’s Lars Bruening on partnership working amid environmental challenges

Roche Basel Switzerland

Roche faces biosimilar blitz in 2018

Analysts predict copycat competitors will slow the Swiss group’s revenue growth

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Amgen set for Kyprolis label boost after CHMP backing

Multiple myeloma treatment set to add new survival data

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EMA’s Amsterdam home will not be ready in time

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

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EMA hands UniQure orphan status first in Huntington’s

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

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Amgen and Allergan win first EU approval for Avastin biosimilar

Mvasi, their version of Roche's blockbuster, is licensed for six types of cancers

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MHRA: No change for pre-Brexit products after UK exits the EU

And UK plans to follow EU rules for an implementation period after March 2019

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Novartis gets speedy reviews for new Kymriah filings

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

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