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Dr Reddy’s combines forces with the Russian Direct Investment Fund for clinical trials and supply of Sputnik V in India, amid what it views as “very important” data points in early studies of the COVID-19 vaccine.
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.
US FDA Commissioner Hahn’s credibility is in question following an emergency use authorization for convalescent plasma, leading some former officials to push for new agency leadership. Hahn’s actions, combined with President Trump’s attack on FDA staff as being ‘deep state’ actors, may compromise the public trust in the agency’s work during COVID-19 and beyond, former FDA officials say
The company – one of the frontrunners in the race to develop a COVID-19 vaccine – has voluntarily put a hold on the Phase III trial due to an adverse event.
The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
The deal would include an option for expansion to 160 million doses of the mRNA-based vaccine.
Cold chain distribution requirements are a major downside for mRNA-based vaccines, but Moderna may have the edge over Pfizer/BioNTech's candidate.
The pandemic phase will last through late 2021/early 2022, becoming a more seasonal opportunity for several years after, Pfizer management predicted during the company's second quarter call.
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