Biogen
1924 articles about Biogen
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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Eisai Completes Submission of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA
4/1/2024
Eisai Co., Ltd. and Biogen Inc. announced that Eisai submitted to the U.S. Food and Drug Administration a Supplemental Biologics License Application for monthly lecanemab-irmb intravenous maintenance dosing.
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The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.
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See our latest overview of people coming and going from executive positions at biopharma companies covered by BioSpace.
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AbCellera to Collaborate with Biogen to Discover Therapeutic Antibodies for Neurological Conditions
3/11/2024
AbCellera (Nasdaq: ABCL) and Biogen Inc. (Nasdaq: BIIB) have entered into a strategic collaboration to discover antibodies for a novel target that enables the delivery of biotherapeutics to the brain for indications in neuroscience.
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New Biomarker Data Add Further Evidence Supporting the Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs after Gene Therapy
3/6/2024
Biogen Inc. announced interim 6-month biomarker data from the initial 29 participants in the open-label RESPOND study.* The Phase 4 study evaluates clinical outcomes and safety following treatment with SPINRAZA over a 2-year period in infants and toddlers with spinal muscular atrophy who have unmet clinical needs after treatment with Zolgensma®.
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Despite the approval of two novel therapies for this uniformly fatal neurodegenerative disease, experts say regulatory standards and expectations are still evolving.
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Biogen Highlights New Data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024 Annual Meeting
3/4/2024
Biogen Inc. (Nasdaq: BIIB) announced it will present new data from its Alzheimer’s disease (AD) portfolio at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™ 2024), taking place March 5-9 in Lisbon, Portugal and virtually.
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From entering college in China at just 15 to co-inventing a drug for Bayer, Mei’s career journey has been far from average. Now CMO at Editas, he’s not done yet.
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Patient advocacy groups aided in the development of the very first marketed drugs for certain rare diseases, including progeria and Friedreich’s ataxia.
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Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP
2/23/2024
Biogen Inc. announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® for the treatment of adults with amyotrophic lateral sclerosis, associated with a mutation in the superoxide dismutase 1 gene.
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After a slow start to 2023 in an uncertain economic climate, biopharma mergers and acquisitions are on the rise.
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Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it.
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The Department of Justice is seeking more information regarding Biogen’s overseas operations, while the Securities and Exchange Commission is looking into the launch of the now-defunct Alzheimer’s disease therapy Aduhelm.
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Biogen Reaps Rewards of Reata Buyout with EU Approval for Skyclarys in Friedreich’s Ataxia
2/13/2024
Following Biogen’s $7.3 billion acquisition of Reata Pharmaceuticals in July 2023, the drug on Monday was approved in the European Union for treating the rare genetic disorder that causes progressive damage to the nervous system. -
In the fourth quarter of 2023, Biogen’s revenue from multiple sclerosis drugs fell 8% due to generics competition and the company paid $60 million in close out costs related to Alzheimer’s treatment Aduhelm.
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Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia
2/12/2024
Biogen Inc. (Nasdaq: BIIB) announced the European Commission (EC) has authorized SKYCLARYS® (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older.
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Biogen to Realign Resources for Alzheimer's Disease Franchise
1/31/2024
Biogen Inc. (Nasdaq: BIIB) today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area expected to drive near and long-term growth.
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The company on Wednesday said it is ending all development and commercialization activity for its Alzheimer’s disease drug Aduhelm to focus on Leqembi with partner Eisai.
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Biogen gained exclusive ex-U.S. rights to Ampyra in 2009 and is selling the drug under the brand name Fampyra in international markets.