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Compassionate use programme

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New cancer meds and drug extensions top CHMP recommendations

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

Sanofi reception

Sanofi’s Lantus follow-up nears European approval

CHMP backing for Toujeo follows hot on the heels of its US approval by the FDA

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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

Future gazing: What does 2015 hold for NICE?

Undermined by the CDF, the Institute is set to face a number of challenges this year

- PMLiVE

Communicating value

The global recession has changed the way the industry needs to market its medicines

- PMLiVE

England’s Cancer Drugs Fund: Fixing a broken system

Following the culling of 16 medicines from the Fund PME looks at how to improve market access for new oncology products

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EMA defends Humira redaction policy from transparency criticism

Regulator says spirit of trial transparency intact after its handling of AbbVie reports

Gathering pace: adaptive pathways

EMA looks at how the model could work in practice and picks first drugs for its pilot project

- PMLiVE

Imbruvica gets FDA OK for rare lymphoma

Cancer drug available in US to treat Waldenström's macroglobulinaemia          

- PMLiVE

NICE backs first ‘ultra-orphan’ drug Soliris

Final guidance backs Alexion’s treatment for very rare blood clot condition

- PMLiVE

Abraxane on course for lung cancer indication in EU

CHMP backs news indication for Celgene drug

- PMLiVE

Indian generics firm GVK set to be hit with European sales ban

EU regulator raises concerns on conduct of drug studies in India

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