Gilead Sciences’ remdesivir could get the nod from the European Medicines Agency this week as a treatment for COVID-19, paving the way for swift EU approval.
The European Medicines Agency could this week recommend that Gilead Sciences’ antiviral drug remdesivir be approved for treating COVID-19 across the EU.
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CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
PharmaMar, which wants to use the Jazz Pharmaceuticals-partnered drug, lurbinectedin, in combination with Roche’s Tecentriq for treating extensive-stage small cell lung cancer, is one of two companies that this month sought an accelerated assessment of their planned EU marketing applications.
Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.
