EMA proposes modifying pre-existing clinical trials during public health emergencies Draft guidance has suggested trial adaptations, including changing endpoints, introducing new patient cohorts, adding new trial arms and adapting randomisation.…
Medicine approval times in Europe to be cut by almost 15% The Council of the European Union said that planned changes to European pharmaceutical legislation will also help streamline procedures to quicken supply chains.…
Eye disorder is a ‘very rare’ side effect of weight-loss drugs, concludes EMA review The review found that non-arteritic anterior ischemic optic neuropathy may affect up to 1 in 10,000 people taking semaglutide medicines.…
MHRA warns of pulmonary aspiration risk for GLP-1 receptor agonists during general anaesthesia or deep sedation A review has found that all available data support a risk of pulmonary aspiration from glucagon-like peptide-1 or dual glucose-dependent insulinotropic polypeptide receptor agonists, owing to their association with delayed gastric emptying.…
Everything you need to know about NICE’s decisions on ‘game-changing’ Alzheimer’s drugs In August and October 2024, the National Institute for Health and Care Excellence issued a decision not to recommend two new drugs for Alzheimer’s disease that experts had previously welcomed for their disease-modifying effects. We explain the reasons behind their decisions.…
MHRA finds no link between GLP-1 receptor agonists and suicidal behaviour The regulator says it will continue to monitor the risk of severe psychiatric reactions and assess new data as they become available.…
EMA tells countries to prioritise weight loss drugs for patients ‘with greatest need’ A European Medicines Agency steering group has asked member countries to work with marketing authorisation holders to “control and optimise the distribution” of glucagon-like peptide-1 receptor agonists.…
EMA may ask manufacturers to increase production capacity in response to medicines shortages The European Medicines Agency has published a list of new recommendations to be implemented on a case-by-case basis, depending on vulnerabilities in the supply chain.…
EMA finds no link between GLP-1 receptor agonists and suicidal thoughts The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has confirmed that no update to product information is warranted.…
EMA committee recommends suspension of almost 400 medicines owing to flawed studies The European Medicines Agency said irregularities in study data and other inadequacies had “raised serious concerns about the validity and reliability of data” from studies conducted at Synapse Labs.…
