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Amicus Therapeutics, Inc.

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Latest From Amicus Therapeutics, Inc.

Sanofi Bags EU Approvals But Fumes At Regulator

Although Nexviadyme has been approved, the French group is still unhappy about the EMA's view that the Pompe disease therapy should not be classified as a new active substance.

Rare Diseases Approvals

At Hard-Hit Gene Therapy Company Freeline, CEO Believes A Turnaround Is Possible

Michael Parini talks to Scrip about how a new focus at the company can help it prove the value of its AAV-based gene therapy platform.

Commercial Clinical Trials

Finance Watch: Q1 Biopharma IPOs Shrink To A Fraction Of 2021 Total

Public Company Edition: Only nine drug developers went public in the US, raising $807m in the first quarter, versus 32 IPOs raising $5.2bn in Q1 of last year. Also, MoonLake closed its SPAC merger, Sanofi priced €650m in sustainability-linked bonds in €1.5bn note sale, and Kaleido will cease operations.

Financing Innovation

Excuses, Excuses: How ‘Delayed’ Confirmatory Trials Are Explained By FDA

US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.

Post Market Regulation & Studies Review Pathway
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