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Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings

Executive Summary

Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.

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Genentech’s SMA Type 1 Data Strengthen Case Backing Risdiplam Approval

With top-line data showing efficacy in type 1 SMA patients, risdiplam may be able to obtain a label that would address significantly more patients than Novartis’ Zolgensma. Final efficacy data will show how drug’s efficacy compares to Biogen’s Spinraza.

Evofem Takes Aim At Preventing Pregnancy And STIs With Amphora

Evofem Biosciences is preparing for Phase III trials for Amphora, an on-demand contraceptive that has surpassed Phase II endpoints in preventing bacterial sexually transmitted infections. 

Rapid FDA Review For Roche’s SMA Contender

Roche files quickly to keep up with Novartis’s gene therapy Zolgensma.

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