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Amarin has settled with Canada-based generic drugmaker Apotex to avoid patent litigation relating to its planned generic of Amarin’s cardiovascular drug Vascepa (icosapent ethyl). Read More
The UK has authorized the use of the corticosteroid dexamethasone to reduce the risk of death in COVID-19 patients requiring ventilation or oxygen. Read More
A majority of European clinical trials of COVID-19 drugs are being run by universities and companies who either lack experience or have a poor track record in uploading their results to the EU’s trial database, which could lead to wasted research, according to a new report. Read More
A small study of early COVID-19 patients in Italy showed Roche’s Actemra (tocilizumab) provided no benefit, the Italian Medicines Agency (AIFA) said. Read More
The FDA has been forced to streamline its guidance development process during the COVID-19 pandemic, and the change is likely to shape its approach beyond the pandemic, says Center for Biologics Evaluation and Research (CBER) Director Peter Marks. Read More
A federal appeals court has upheld a lower court’s ruling that HHS lacks the authority to require drugmakers to disclose the list prices of drugs in television advertisements. Read More
Sponsors of trials impacted by the COVID-19 pandemic have several statistical analysis options for mitigating the effect of missing data, according to the FDA. Read More
Chinese government-owned vaccine developer Sinopharma says its COVID-19 vaccine candidate has generated a 100 percent antibody response in patients who were given two medium doses 28 days apart. Read More