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Windlas Healthcare drew a warning letter from the FDA after agency investigators found serious data integrity violations at its API manufacturing facility in Uttarakhand, northern India. Read More
Biogen has filed suit against New York-based Creative Biolabs, claiming that the company has been copying its patented Alzheimer’s drug candidate aducanumab and selling imitation products to researchers online. Read More
Sponsors in the EU should conduct risk assessments of all trial procedures in the face of the COVID-19 outbreak, according to a guidance issued by the European Medicines Agency (EMA) on Friday that also suggests they should hold off on initiating trials or adding participants to current trials. Read More
Several drugmakers have committed to donating antimalaria treatments chloroquine and hydroxychloroquine after the Trump Administration showed interest in the drugs as potential COVID-19 treatments. Read More
The pace of research is ramping up as drugmakers and organizations accelerate efforts on COVID-19 treatment and vaccine candidates, with a number of accomplishments recently, especially for vaccines: Read More
The FDA said it does not plan to object to delays in adverse event reporting for medical products during a pandemic, in a final guidance released yesterday. Read More
The European Medicines Agency yesterday urged sponsors to do multi-center, multi-arm clinical trials to generate evidence on COVID-19 treatments, saying they’re most likely to generate the evidence needed to rapidly develop and approve treatments. Read More
Roche is making progress in efforts to repurpose its immunosuppressive drug Actemra (tocilizumab) for treating the coronavirus, gaining FDA approval for a phase 3 trial, the company announced Thursday. Read More
President Trump yesterday promised in sweeping terms that the FDA will slash regulatory red tape to get COVID-19 therapeutics to patients as FDA Commissioner Stephen Hahn walked back some of Trump’s comments about what is realistic without jeopardizing patient safety. Read More