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- PMLiVE

Compassionate use programme

- PMLiVE

No price ceiling for rare disease drugs, say MPs

BIA survey comes ahead of consultation on evaluation framework for ultra-orphans

- PMLiVE

EMA to restrict use of domperidone and diacerein

Regulator's pharmacovigilance advisors also want insomnia drug zolpidem's labelling tightened up

NICE and ‘ultra orphans’

NICE and its processes for ‘highly specialised therapies’

EU flag

J&J gets EU green light for novel TB drug

Sirturo approved to treat multidrug resistant form of the disease

- PMLiVE

Compulsory evaluation in France

French authorities will expect robust health economic cases to be made for some drugs

National Institute for Health and Care Excellence NICE logo

NICE: Alexion must justify Soliris’ high cost

UK body unable to recommend ‘ultra-orphan’ drug

- PMLiVE

Gliptins don’t cause pancreatic cancer say FDA and EMA

Regulators back safety of diabetes medicine class

- PMLiVE

Pharma companies back Rare Disease Day

Genzyme, Shire and more hold global campaigns today

- PMLiVE

AZ gets limited approval for metreleptin in US

First FDA-backed treatment for rare disease lipodystrophy

- PMLiVE

Biosimilars: friend or foe for healthcare systems?

An opportunity in Europe, but widespread acceptance and uptake is by no means a done deal

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Pharma wants review of EMA pharmacovigilance fees

EFPIA among associations to call for ‘balanced and transparent’ funding

- PMLiVE

Value-based assessment

NICE is set to modify the way it operates, but the changes shouldn’t come as a surprise

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