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Inside The COVID-19 Pipeline
An Interactive View Of Vaccines & Treatments In Development
Around the world, government agencies, academic and other researchers and the biopharmaceutical industry have rushed to see what drugs could help treat COVID-19 and the symptoms it causes, and accelerate a vaccine that could help limit the spread of the pandemic. This chart will be updated daily as additional research gets underway.
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Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
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HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.
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Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.
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Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
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The Pink Sheet takes an exclusive look at the complete response letter, which shows the information on application deficiencies that could become widely available if FDA leaders succeed in releasing CRLs in real time.
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The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.
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The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.