europeanmedicineagency
The pharmaceutical company behind a drug for amyotrophic lateral sclerosis (ALS) said it would start a process to remove it from the US and Canadian markets. Amylyx Pharmaceuticals said the drug for ALS also known as motor neurone disease (MND) or Lou Gehrig's disease would no longer be available for new patients after a trial showed it did not work. "Patients currently on therapy in the US and Canada who, in consultation with their physician, wish to stay on treatment can be transitioned to a free drug [programme]," the company said. Trials showed no difference to placeboEarlier this month, A...
Euronews (English)
The EMA has only lately started to look more into the issue of shortages – particularly in public health emergencies or during so-called major events – after an extension of its mandate in 2022 to improve the agency's role in crisis preparedness. National and EU regulators still heavily rely on information they receive from private companies, however, when assessing supply vulnerabilities. “We have to encourage greater transparency because the only way to help mitigate [shortages] is if we understand. And we can only understand if we know,” EMA boss Cooke said. The need to keep information flo...
Euronews (English)
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