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- PMLiVE

phentermine/topiramate ER

- PMLiVE

Commercial innovation in biotech organisations

Blue Latitude Health speaks to Salma Jutt Vice President of US Marketing and Head of Commercial Innovation at a biotech specialising in treating weight loss and obesity.

Blue Latitude Health

- PMLiVE

EMA starts rapid review of Shire’s HAE antibody

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

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ViiV’s two-drug HIV combo backed by CHMP

The committee also backs two biosimilar medicines

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Novo Nordisk’s semaglutide obesity trial hits the mark

The injection helped adults lose up to 13.8% of their body weight in a year

- 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

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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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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

- 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

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EMA forges closer ties with HTA umbrella group

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

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