HEALTHCARE HOPE

Orphan medicines

There are over 6,000 rare diseases and it is estimated that around 30 million people in the European Union (EU) suffer from one of more than 6,000 rare diseases. Treating them can be difficult, because there are only a few medicines available. This represents a huge unmet medical need and a significant public health challenge. The EU’s orphan designation programme was launched in 2000 to encourage companies to develop medicines for rare diseases. To date, over 1,900 medicines have been designated as orphan medicines; by the end of 2017, over 140 of them were on the market, said the European Medicines Agency.

REGULATORY ACTION

Stemcell warning

The US Food and Drug Administration has posted a warning letter issued to American CryoStem Corporation, New Jersey and its Chairman/Chief Executive Officer, John S. Arnone, for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk.

YEMEN CRISIS

1,000 days of war

“We have passed the grim milestone of 1,000 days of war in Yemen. As violence has escalated in recent days, children and families are yet again being killed in attacks and bombardments,” the World Health Organisation, Unicef and the World Food Programme said in a statement. “The conflict has created the world’s worst humanitarian crisis,” the statement said.

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