Biogen

NEWS
Not everyone is so confident that Aduhelm will transform the Alzheimer’s drug development landscape.
Despite controversy over the drug’s effectiveness, it appears to have spiked interest in investing in Alzheimer’s drug companies, something that had been on the decline for several years.
The U.S. Food and Drug Administration granted approval of Biogen’s aducanumab for the treatment of Alzheimer’s disease.
June is turning out to be a busy month for PDUFA dates for the U.S. Food and Drug Administration. Here’s a look at this week’s dates.
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.
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