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Latest From Assertio Therapeutics, Inc.

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A proposed rule from the US agency would move the in vitro diagnostics from high-risk class III to class II with special controls, eliminating the requirement for a PMA.

Regulation Review Pathway

Coccidioidomycosis Outlook Highlights The Limits Of Regulatory Incentives

The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.

Rare Diseases Review Pathway

Finance Watch: CureVac’s IPO Is Ready For Launch

Public Company Edition: The German mRNA-focused company could raise up to $245m based on its proposed price range, but investor interest could drive the offering’s total higher. Also, Perceptive launches another SPAC, Regeneron sells $2bn in debt and Biohaven secures up to $950m. 

Financing Business Strategies

COVID-19 Registry Aims To Map And Address Potential Test Shortages

Medtech industry group AdvaMed has developed a registry to share data on how many COVID-19 diagnostic tests are available and where they are, with a goal of foreseeing and nipping in the bud potential test shortages. Thirteen diagnostic manufacturers – including Abbott, Roche, Siemens and Thermo Fisher Scientific – have partnered with AdvaMed on the initiative.

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