Rapid US FDA Review For Roche’s SMA Contender
Physicians Keen On Oral Formulation
Roche files quickly to keep up with Novartis’s gene therapy Zolgensma.
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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.
Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings
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.
US FDA Puts IT Zolgensma Studies On Partial Clinical Hold
The roller coaster ride for Novartis with its high-profile gene therapy Zolgensma continues as the FDA places a partial hold on trials of an intrathecal version aimed at older SMA patients on the back of nerve inflammation seen in a preclinical study.