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Tysabri Long-Term Users Must Provide Additional Consent In Europe
A three-month EMEA safety review confirms that two years of treatment with the monoclonal antibody increases the risk for PML.
More from Europe
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Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
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If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
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Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
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A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.
More from Geography
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If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
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Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
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Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.