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The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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ORI Capital announced Thursday that it has raised more than a quarter of a billion dollars for its second life sciences fund, which will invest in early-stage biotech companies using the firm’s proprietary AI-driven platform.
The settlement, which includes an upfront $75 million payment to Gavi, ends arbitration related to a 2021 advance purchase agreement involving Novavax’s prototype vaccine NVX-CoV2373.
Both Pfizer and Moderna surprised analysts with sales of COVID-19 vaccines and treatments, yet the companies still need to manage declining revenues in the years to come.
While COVID vaccine revenue dropped 43% compared to the same period last year, Moderna on Thursday reported a profit of $217 million which beat analyst estimates, driven by deferred payments and cost savings.