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Biogen gene therapy for rare eye disease falls short in key clinical trial
A Biogen gene therapy for a rare, inherited eye disorder that leads to blindness has failed a key clinical trial. The preliminary results are the latest blow to the company’s efforts to expand its...
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Biogen teams up with Ginkgo Bioworks in gene therapy manufacturing pact
Biogen is reaching across the Charles River, striking up a gene therapy manufacturing alliance with synthetic biology firm Ginkgo Bioworks. Ginkgo will use its technology to accelerate and make more...
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FDA picks accelerated approval path to decide in favor of Biogen Alzheimer’s...
A Biogen Alzheimer’s drug that clears amyloid plaque from the brain has been granted accelerated approved by the FDA. The drug, which will be marketed as Aduhelm, is the first new FDA-approved...
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Confirming benefit of Biogen Alzheimer’s disease drug will take 8 years
Biogen is still discussing with the FDA the clinical trial design to confirm the benefit offered by its newly approved Alzheimer’s disease drug, Aduhelm. According to a timeline set by the regulator,...
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FDA tweaks Aduhelm’s label, narrows use of the Biogen drug to mild Alzheimer’s
The drug label for Biogen Alzheimer’s disease drug Aduhelm has been revised to clarify that its use is for patients with mild forms of the neurodegenerative disorder. The change aligns the prescribing...
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CMS considers coverage of Biogen’s costly new Alzheimer’s drug
CMS plans to review and determine coverage for Biogen’s Aduhelm, the first new Alzheimer’s disease treatment in decades. But the jury is still out on the drug’s effectiveness. Not to mention, its hefty...
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Biogen reaches across globe and pays $125M to land its next new MS drug
By paying $125 million up front for rights to multiple sclerosis drug candidate orelabrutinib, Biogen secures a place among those companies trying to treat the disease by targeting a particular enzyme...
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Biogen and Eisai unveil details for five-year, real-world Aduhelm clinical trial
Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational study, which is one of three...
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Biogen and Samsung land FDA approval for biosimilar to blockbuster Roche drug
The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat...
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Another Eisai, Biogen Alzheimer’s drug is filed for speedy FDA review
Eisai is seeking accelerated FDA approval of lecanemab, an Alzheimer’s disease drug that is part of a research alliance with Biogen. The drug is following the same path blazed earlier this year with...
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Biogen ALS drug fails main goal of key test, but company points to other results
Biogen amyotrophic lateral sclerosis drug, tofersen, failed a Phase 3 clinical trial, but the drug showed improvement according to secondary and exploratory goals of the study. Based on those results,...
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Biogen projects confirmatory study for Alzheimer’s drug will take four years
Six months after Biogen was awarded regulatory approval for its Alzheimer’s disease drug Aduhelm, the company is laying out a timeline for the post-marketing study to confirm whether the drug works....
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Biogen slashes price of Alzheimer’s drug by half as CMS coverage decision looms
The price of Biogen Alzheimer’s disease drug Aduhelm will be cut in half at the start of 2022, a move that comes as a Medicare recommendation on coverage is expected early next year. Meanwhile, Biogen...
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CMS proposes limited coverage of Biogen Alzheimer’s drug, only in clinical...
The Center for Medicare and Medicaid Services proposes covering Biogen Alzheimer’s disease drug Aduhelm only for people enrolled in a clinical trial. In explaining this proposal, the agency cited the...
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Final CMS decision limits coverage of Biogen’s Aduhelm to those in clinical...
Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the...
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Biogen pulls Alzheimer’s drug application in Europe as EMA calls data...
Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee...
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Biogen gets in tune with MedRhythms to develop new digital therapeutic for MS
Biogen struck a deal that could bring a digital therapeutic to its multiple sclerosis product portfolio. The drugmaker is partnering with startup MedRhythms in the development of a therapy that...
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Aduhelm’s loss is a win for value-based drug pricing
Value-based pricing could have shown us with more certainty the real level of effectiveness of Aduhelm. Maybe it is worth paying something for; and value-based contracts are the only way to figure that...
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Biogen bolsters case for ALS drug under FDA review with new published data
A Biogen drug designed for a genetically defined form of amyotrophic lateral sclerosis led to patient improvement at a 12-month analysis, according to data now published in the New England Journal of...
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Eisai, Biogen beat expectations with data that support Alzheimer’s drug approval
Eisai Alzheimer’s disease drug candidate lecanemab now has data from a pivotal study showing a statistically significant reduction in cognitive decline. Lecanemab is already under FDA review for...
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