Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|July 30, 2020
EMA Starts Review of Dexamethasone as COVID-19 Treatment
Author(s)Pharmaceutical Technology Editors
EMA has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.
Advertisement
The European Medicines Agency (EMA) has announced in a July 24, 2020 press release that it has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.
Specifically, the regulatory agency is reviewing data from the RECOVERY study arm that looked at the effects of adding dexamethasone to usual care in adults receiving invasive ventilation, in those receiving oxygen (e.g., through a mask), or in those receiving no oxygen. In the study, any deaths that happened 28 days after starting dexamethasone treatment were recorded and preliminary results indicate that dexamethasone reduced mortality in patients receiving respiratory support compared with usual care.
With this review, EMA hopes to provide an opinion on the RECOVERY study and also on the potential use of dexamethasone for the treatment of adults with COVID-19. More information will be presented by the agency when available.
Source:
Advertisement
Related to this article
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
Jason Bertola, executive director of Commercial Development for the Advanced Synthesis Platform at Lonza in North America, explains the demand for spray drying and the hurdles involved with scale up, in an interview with PharmTech.
API-gated journals may skew pharma regulatory research as AI agents favor accessible sources, raising citation integrity and pharmacovigilance risks.
The FDA has approved remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
The company is showcasing new development solutions and advanced digital technologies including its new OSD Express and Steriles Express solutions for drug development.
Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.
Advertisement
Advertisement