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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
CureVac has won approval in Germany and Belgium for a phase 1 trial of its COVID-19 vaccine, just days after the German government announced it was acquiring a 23 percent stake in the company. Read More
Regulators, drugmakers and researchers need to work in parallel to speed development of COVID-19 vaccines and treatments and prepare for the hurdles still to come, a former FDA commissioner advised. Read More
Cosmaceutical Research Lab was hit with an FDA warning letter for serious violations uncovered during an inspection of the firm’s manufacturing facility in British Columbia, Canada. Read More