Biogen

NEWS
Alzheimer’s patients and their families wait with hope that this will mean some offer of treatment, while physicians that treat Alzheimer’s patients are mulling the implications of the drug, often with hesitancy and skepticism.
FDA
The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
Less than two weeks after Ginkgo Bioworks announced a merger with SPAC Soaring Eagle Acquisition Corp., it announced a collaboration partnership with Biogen.
Biogen reported that its gene therapy, cotoretigene toliparvovec, failed to hit the primary endpoint of the Phase II/III XIRIUS trial for X-linked retinitis pigmentosa (XLRP).
Biogen is going all-in on a stroke drug it has been developing for the past three years in collaboration with Japan-based TMS Co.
With Biogen’s potential treatment for Alzheimer’s, aducanumab, coming in weeks before a U.S. FDA decision, ICER wrote a punishing report slamming the drug for insufficient efficacy and recommending a low price point if approved.
BioSpace takes an in-depth look at the Top 25 of Q1. You should be aware of these biopharma companies as they hold a great future ahead. So, check them out.
FDA
The U.S. FDA says it is unable to approve Biogen supplemental Biologic License Application (sBLA) for subcutaneously delivered TYSABRI® for the treatment of relapsing multiple sclerosis (MS), at least while the sBLA remains in its present form.
A multi-day conference hosted by Biogen during the early days of the COVID-19 pandemic has been determined to be a super-spreader event, with more than 300,000 infections linked to the conference.
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