Biogen’s Q2 Highlights Need For Near-Term Successes
Second quarter performance was better than expected, but commercial weaknesses show the need for R&D wins and M&A deals as Tecfidera generics and aducanumab uncertainty weigh on the company.
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Risdiplam’s efficacy across two clinical trials and oral dosing made it a credible threat before its US FDA approval, but its weight-based pricing falls below Biogen’s Spinraza and Novartis’s Zolgensma.
Biogen said some spinal muscular atrophy patients are currently being treated with Spinraza after receiving the Novartis gene therapy – its main competitor – so it will start a study of the risk/benefit in 2021.
Biogen said it will appeal the district court decision invalidating the '514 patent for Tecfidera but Mylan said it looks forward to launching a generic after final FDA approval is granted. The ANDA has a November action date.