New gene therapy to treat spinal muscular atrophy

EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to treat babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. There are currently limited treatment options for children with […]

EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic

EMA is aware of recent media reports and publications[1] which question whether some medicines, for instance angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines), could worsen coronavirus disease (COVID-19). ACE inhibitors and ARBs are most commonly used for treating patients with high blood pressure, heart failure or kidney disease. It […]

Consumer credit agreements must specify clearly and concisely how the withdrawal period is to be calculated

In 2012 a consumer concluded with a credit institution, the Kreissparkasse Saarlouis, a credit agreement secured by mortgages for a sum of €100 000, at an annual borrowing rate of 3.61% fixed until 30 November 2021. The credit agreement provides that the borrower has a period of 14 days to withdraw, that period running from […]

Global regulators map out data requirements for phase 1 COVID-19 vaccine trials

Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making on two key […]