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- PMLiVE

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Novartis building

Novartis pulls EMA application for expanded Tasigna use

And Boehringer confirms it won't seek approval for faldaprevir as it exits hepatitis C

- PMLiVE

Biosimilar Lantus leads CHMP opinions

Boehringer and Lilly’s insulin one of six new medicines recommended for EU approval

- PMLiVE

Avastin first biologic backed in EU for resistant ovarian cancer

Roche drug recommended in latest round of CHMP opinions

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Updated EMA reports better suited to HTA needs

Changes to drug licensing reports are helping to support reimbursement decisions

- PMLiVE

EMA gives December deadline for information updates

Pharma companies must revise their medicines information by year-end

- PMLiVE

EMA: We will allow clinical data download

Regulator says it hasn't watered down trial transparency measures

- PMLiVE

EMA adaptive licensing project gathers pace

Regulator picks two drugs to pilot early access scheme

Roche - Basel

CHMP turns down Avastin for brain cancer

Roche set to be denied expanded use for oncology drug in Europe

- PMLiVE

CHMP backs European approval for six new medicines

Recommends drugs by PTC Therapeutics, Roche, Biogen Idec, Octapharma, Alcon and Veloxis Pharma

- PMLiVE

Teva backs laquinimod for MS despite CHMP rejection

EMA confirms negative opinion after re-examination

- PMLiVE

Following the biologic path

Biosimilar regulations in Canada, the US and Europe all have a degree of uncertainty

- PMLiVE

Bayer’s Nexavar recommended for thyroid cancer in EU

CHMP backs extra indication for cancer drug

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