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- PMLiVE

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- 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

EU flag

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

Santhera closer to filing for muscular dystrophy drug

Catena/Raxone slows loss of lung function in late stage trial

Shire Basingstoke

Shire boosts rare disease portfolio with $260m Lumena deal

Acquisition of US company will bring two mid-stage candidates for rare liver diseases

- PMLiVE

Following the biologic path

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

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