Category list : European Medicines Agency (EMA)
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Why we need to talk about sex and clinical trials Subscription
The under-representation of women in clinical trials is slowly being addressed, but we cannot move towards truly personalised healthcare unless we have an equal balance of the sexes in all new medicine trials.
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Remdesivir could be granted conditional marketing authorisation 'in the coming days', says EMA
The investigational antiviral medicine, remdesivir, may be granted a conditional marketing authorisation as a treatment for COVID-19 “in the coming days”, the head of the European Medicines Agency has said.
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First oral GLP-1 treatment for type 2 diabetes recommended by EMA Subscription
The European Medicines Agency’s human medicines committee has recommended the first oral glucagon-like peptide receptor agonist treatment for adults with uncontrolled type 2 diabetes mellitus.
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The most innovative cancer drugs take longest to reach patients, study suggests Subscription
The most innovative new cancer drugs are taking longer to pass through clinical trials, licensing and eventual appraisal by the National Institute for Health and Care Excellence, an analysis carried out by the Institute of Cancer Research has suggested.
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Another manufacturer recalls ranitidine products over NDMA contamination
Medley Pharma has recalled unexpired stocks of ranitidine over possible contamination with N-nitrosodimethylamine.
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EMA committee recommends caution in use of tofacitinib owing to increased risk of blood clots Subscription
The European Medicines Agency’s Committee for Medicinal Products for Human Use has endorsed recommendations that tofacitinib could increase the risk of blood clots in the lungs and should be used with caution in all patients already at high risk.
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First non-injectable treatment for severe hypoglycaemia recommended by EMA committee
A European Medicines Agency committee has recommended the first non-injectable treatment for severe hypoglycaemia.
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Medicines recall drug alert issued for potentially contaminated ranitidine products
Pharmacists are being advised to stop supplying some ranitidine products after it was revealed that they may be contaminated with the impurity N-nitrosodimethylamine.
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Safety committee recommends limiting use of high-strength estradiol creams for postmenopausal women
The European Medicines Agency’s safety committee has recommended limiting use of high-strength creams containing 100 microgram/gram of estradiol to a single treatment period of up to four weeks.
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EMA tells drug manufacturers to test for probable carcinogen
The European Medicines Agency has told drug manufacturers to test all medicines that contain chemically synthesised active substances for the presence of nitrosamines.
