Sinovac’s COVID-19 vaccine has an efficacy rate of 50% in one hard-hit region of Brazil, a study finds, which could fuel fresh doubts over the efficacy of Chinese vaccines and raise the urgency to change current vaccination strategy.
A new real world studyreviewing the efficacy of the CoronaVac vaccine from Sinovac Biotech Ltd., a Beijing-based developer, could fuel fresh doubts about the effectiveness of Chinese COVID-19 vaccines.
The study, unveiled on 7 April by preprint website Medtrxiv.com and not peer-reviewed, focused on the region of Manaus, an Amazonian city that has seen the pandemic spread out of...
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
