EMA Highlights: EMA wants to improve safety of first-in-human trials
by Gary Finnegan: The EU drug watchdog is reviewing the guidelines on first-in-human clinical trials in response to the tragic death of a participant in a trial in… read more.
by Gary Finnegan: The EU drug watchdog is reviewing the guidelines on first-in-human clinical trials in response to the tragic death of a participant in a trial in… read more.
by Gary Finnegan: Most successful applicants to the EU drug watchdog, the European Medicines Agency, have something in common: they seek scientific advice from the regulator when developing… read more.
by Gary Finnegan: Cooperation between medicines regulators and health technology assessment (HTA) bodies is helping to streamline clinical studies of new medicines, according to a new report.
by Gary Finnegan: The European Medicines Agency (EMA) has published a draft version of a new paper on how to extrapolate clinical trial data from adults to children…. read more.
by Gary Finnegan: The European Medicines Agency (EMA) is coordinating a collective response to the medicines shortages which have plagued several European countries in recent years.
by Gary Finnegan: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of seven new medicines, including one advanced therapy medicinal product (ATMP), at… read more.
Silvio Danese, Humanitas Clinical and Research Hospital, Milan, Italy. Article by Maria Dalby – The current paradigm for managing inflammatory conditions is to suppress the inflammatory response by… read more.
by Bruce Sylvester: Smoking cessation treatment with varenicline and bupropion does increase serious neuropsychiatric side effects, researchers reported in The Lancet on April 22, 2016.
by Bruce Sylvester: Treatment with clemastine fumarate, an over-the-counter antihistamine used for allergies and the common cold, has partially reversed damage to the visual system in people with… read more.
by Bruce Sylvester: Hyrdomorphone, a licensed pain medication, shows efficacy in treating chronic heroin addiction, researchers from the SALOME (the Study to Assess Longer-term Opioid Medication Effectiveness) trial… read more.
by Gary Finnegan: Six new medicines, two of which had been fast-tracked, were given positive reviews from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)…. read more.
by Gary Finnegan: The European Medicines Agency has released a revised guideline on medicines for the treatment of Alzheimer’s disease and other forms of dementia. The publication is… read more.
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