FDA
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 9, 2020.
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This test will give healthcare providers a single result to confirm an HIV diagnosis with patients and differentiate between HIV-1 and HIV-2.
The U.S. government has financially backed the development of six different vaccine candidates aimed at the novel coronavirus. Although billions of dollars have been appropriated to the pandemic, at least four of those potential preventative treatments are predicted to fail in the clinic.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 2, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 31, 2020.
With a new regulatory approval in hand for its FoundationOne Liquid CDx, Foundation Medicine said it plans for the product to be available for commercial use by Friday, Aug. 28.
The U.S. Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi. Let’s look at how this new acne treatment was developed.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 26, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 24, 2020.