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STAT+: FDA commissioner says new vaccine ‘framework’ for industry is coming within weeks

STAT

WASHINGTON — Food and Drug Administration Commissioner Marty Makary said the agency is planning to unveil new guidance for vaccine makers, focused primarily on Covid-19 shots, in the coming weeks. 

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STAT+: Vaccine developer raises $45M for influenza drug trial

STAT

Today, we talk about the readout of Compass Pathways’ psilocybin trial for major depressive disorder, see more vaccine concern and turnover at the FDA, and report from the American Diabetes Association.    Sign up  to get our biotech newsletter in your inbox.

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STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies

STAT

WASHINGTON — Vinay Prasad, an academic and fierce critic of the medical mainstream, will be the next director of the Food and Drug Administration center that oversees the regulation of vaccines, gene therapies, and the blood supply. 

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‘Last roll of the dice’ for a near-term HIV vaccine fails

STAT

A study billed as the last chance to develop an HIV vaccine this decade has been shut down, investigators announced Wednesday at a conference in Harare, Zimbabwe. The trial, known as PrEPVacc, was testing two different vaccine regimens on about 1,500 volunteers in East and Southern Africa.   Read the rest…

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STAT+: RFK Jr.’s latest moves on vaccines

STAT

HHS cancels flu pandemic vaccine contract In a blow to pandemic preparedness, HHS cancelled a nearly $600 million contract with Moderna to develop, test, and license vaccines for flu strains that could trigger future pandemics, including the H5N1 bird flu virus, Helen Branswell and Matthew Herper report.

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STAT+: Cancer vaccines gain momentum, after years of disappointing results

STAT

SAN DIEGO — Cancer vaccines have traveled a potholed road over the last decade. The promise has long been an affordable, personalized cancer vaccine that could train the immune system to recognize proteins from cancer cells and, subsequently, destroy the tumor.

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FDA offers new guidelines for Covid-19 vaccine

STAT

Today, we talk about the uptick in physicians using ctDNA to determine if resected cancers are truly gone, we see the FDA offering new guidelines for Covid-19 vaccines, and more.   Sign up  to get our biotech newsletter in your inbox. Read the rest…

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