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- PMLiVE

betrixaban

- PMLiVE

Boehringer steals lead among NOACs with Pradaxa antidote

Has filed reversal agent for European approval

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New cancer meds and drug extensions top CHMP recommendations

Drugs for rare disease, oncology and diabetes top regulator’s endorsements

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Jinarc backed for European approval in rare kidney disease

Positive opinion for Otsuka comes just before rare disease awareness day

- PMLiVE

Abraxane on course for lung cancer indication in EU

CHMP backs news indication for Celgene drug

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Antibiotics among 7 new drugs backed by EMA

The Medicines Company’s Orbactiv and Cubist’s Sivextro set for European approval

- PMLiVE

CHMP thumbs up for Novo’s obesity drug Saxenda

Diabetes drug liraglutide on course for new indication in EU

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Daiichi’s novel anticoagulant Savaysa cleared in US

Approval comes more than three years after it was approved in Japan

- PMLiVE

Orexigen’s obesity pill Mysimba set for European approval

But sales of the treatment are only predicted to reach $200m by 2016

- PMLiVE

‘Major step forward’ as EMA recommends first stem cell therapy

But wants more clinical trial data to shore up orphan drug's marketing licence

- PMLiVE

Novartis’ heart failure drug on EMA’s fast track

Candidate is the first cardiovascular drug to get accelerated review in the EU

- PMLiVE

Orphan drugs lead CHMP recommendations

Clinuvel's Scenesse is first drug set for European approval to treat rare intolerance to sunlight

- PMLiVE

EMA wants to embed patient viewpoint within drug assessment

Will pilot CHMP benefit-risk evaluation project

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