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=== Aducanumab === {{Main|Aducanumab}} In 2007, the company reached a licensing agreement with Neurimmune, a spin-off from the University of Zurich, for the [[Alzheimer's disease]] drug, [[Aducanumab]], developed by this [[Switzerland|Swiss]] company. Later, Neurimmune sold its rights for license fees for $200 million to Biogen.<ref name="NZZ" /> In December 2014, Biogen announced that Aducanumab for Alzheimer's treatment was preparing to go through a late-stage trial of its experimental Alzheimer's disease treatment after the medication dramatically improved cognition and reduced brain plaque levels in early-stage study.<ref>{{Cite news|last=Pierson|first=Ransdell|date=2014-12-02|title=Biogen plans late-stage Alzheimer's trial, shares rise|language=en|work=Reuters|url=https://www.reuters.com/article/us-biogen-idec-alzheimers-idINKCN0JG1JX20141202|access-date=2021-09-11}}</ref> In March 2015, Aducanumab became the first experimental Alzheimer's treatment to show significant results in regard to slowing down cognitive decline and reducing brain-destroying plaques.<ref>{{Cite news|last=Berkrot|first=Bill|date=2015-03-20|title=Biogen's Alzheimer's drug slows mental decline in early study|language=en|work=Reuters|url=https://www.reuters.com/article/us-biogen-alzheimers-idUSKBN0MG1OU20150320|access-date=2021-09-11}}</ref> In July 2015, Biogen initiated two late-stage studies called ENGAGE and EMERGE, which will assess Aducanumab in adults with early Alzheimer's disease.<ref>{{Cite web|date=2015-09-08|title=Biogen Enrolls First Patient in Global Phase 3 Study of Investigational Treatment Aducanumab (BIIB037) for Early Alzheimer's Disease|url=https://www.businesswire.com/news/home/20150908005533/en/Biogen-Enrolls-First-Patient-in-Global-Phase-3-Study-of-Investigational-Treatment-Aducanumab-BIIB037-for-Early-Alzheimer%E2%80%99s-Disease|access-date=2021-09-11|website=www.businesswire.com|language=en}}</ref> In 2016, Aducanumab decreased amoyloid-beta in the brains of people with early-stage Alzheimer's disease, according to a report published in Nature on August 31, 2016.<ref>{{Cite web|last=Kirsten|title=Investigational antibody treatment yields exciting though preliminary results - UCI MIND|url=https://mind.uci.edu/investigational-antibody-treatment-yields-exciting-though-preliminary-results/|access-date=2021-10-11|language=en-US}}</ref> On March 21, 2019, Biogen announced that the Phase 3 clinical trials of Aducanumab were halted.<ref>{{Cite web|last=Kirsten|title=Phase 3 Trials of Aducanumab Halted - UCI MIND|url=https://www.mind.uci.edu/phase-3-trials-of-aducanumab-halted/|access-date=2021-10-11|language=en-US}}</ref> Biogen announced it would acquire Nightstar Therapeutics for $25.50 per share ($800 million in total). Nightstar focused on adeno-associated virus based gene-therapies for inherited retinal disorders.<ref>{{cite web|title=BIOGEN ANNOUNCES AGREEMENT TO ACQUIRE NIGHTSTAR THERAPEUTICS TO ESTABLISH CLINICAL PIPELINE OF GENE THERAPY CANDIDATES IN OPHTHALMOLOGY|url=https://www.biospace.com/article/biogen-announces-agreement-to-acquire-nightstar-therapeutics-to-establish-clinical-pipeline-of-gene-therapy-candidates-in-ophthalmology/|access-date=2 June 2019|website=BioSpace|date=4 March 2019 }}</ref><ref>{{cite web|title=Biogen Banks on Ophthalmology Gene Therapies With $800 Million Acquisition of Nightstar|url=https://www.biospace.com/article/biogen-banks-on-ophthalmology-gene-therapies-with-800-million-acquisition-of-nightstar/|access-date=2 June 2019|website=BioSpace|date=4 March 2019 }}</ref> With a setback in their drug research, Biogen's shares fell sharply that same month.<ref>{{cite web|last=Annett|first=Timothy|date=21 March 2019|title=Biogen shares plunge after Alzheimer's drug setback|url=https://www.bostonglobe.com/business/2019/03/21/biogen-shares-plunge-after-alzheimer-drug-setback/0MzLJWlEgmo5nHSKWl8esO/story.html|access-date=2 June 2019|work=The Boston Globe}}</ref> It ended the trial of Aducanumab, which it was making along with [[Eisai (company)|Eisai]].<ref>{{cite web|last=Li|first=Yun|date=21 March 2019|title=Biogen posts its the worst day in 14 years after ending trial for blockbuster Alzheimer's drug|url=https://www.cnbc.com/2019/03/21/biogen-shares-plunge-more-than-25percent-after-ending-trial-for-alzheimers-drug-aducanumab.html|access-date=2 June 2019|website=CNBC}}</ref> In October 2019, however, they announced that they would pursue FDA approval together with Eisai.<ref name=":0">{{Cite web|author1=Jacqueline Howard|author2=Jamie Gumbrecht|title=Drugmaker to seek approval for Alzheimer's treatment|url=https://www.cnn.com/2019/10/22/health/biogen-alzheimers-drug-fda/index.html|access-date=2019-10-23|website=CNN|date=22 October 2019 }}</ref> On October 22, 2019, despite two Phase 3 clinical trials being previously halted for futility, Biogen announced its plan to submit for FDA's approval of Aducanumab.<ref>{{Cite web|last=Chelsea|title=Biogen's About Face - UCI MIND|url=https://www.mind.uci.edu/biogens-about-face/|access-date=2021-10-11|language=en-US}}</ref> In May 2020, Biogen wrapped up construction on a state-of-the-art facility in [[Solothurn]], [[Switzerland]], which will produce Aducanumab by late 2021, alongside its [[North Carolina]] manufacturing facility. The [[monoclonal antibody]], co-developed with [[Eisai (company)|Eisai]], attracted considerable interest from biotech investors when [[Warren Buffett]]'s [[Berkshire Hathaway]] bought 648,447 Biogen shares at a combined value of $192.4 million.<ref>Kyle Blankenship (May 7, 2020). [https://www.fiercepharma.com/manufacturing/biogen-s-swiss-facility-wraps-up-construction-to-help-boost-aducanumab-rollout "Biogen gears up Swiss manufacturing facility for potential aducanumab rollout"] ''Fierce Pharma (Manufacturing)''. Retrieved 9 June 2021.</ref> On July 8, 2020, Biogen and [[Eisai (company)|Eisai]] announced that both companies had together successfully submitted for Aducanumab's FDA regulatory and marketing approval.<ref>{{Cite web|last=Kirsten|title=Biogen and Eisai submit aducanumab for FDA approval - UCI MIND|url=https://128.200.55.17/biogen-and-eisai-submit-aducanumab-for-fda-approval/|access-date=2021-10-11|language=en-US}}</ref> On June 7, 2021, the [[FDA]] gave accelerated approval to Aducanumab under the name Aduhelm,<ref>{{Cite web |last=Commissioner |first=Office of the |date=2021-06-07 |title=FDA Grants Accelerated Approval for Alzheimer's Drug |url=https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug |archive-url=https://web.archive.org/web/20210607153129/https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug |url-status=dead |archive-date=June 7, 2021 |access-date=2022-03-22 |website=FDA |language=en}}</ref> which proved to be controversial.<ref>{{Cite news |last1=Belluck |first1=Pam |last2=Kaplan |first2=Sheila |last3=Robbins |first3=Rebecca |date=2021-07-20 |title=How an Unproven Alzheimer's Drug Got Approved |language=en-US |work=The New York Times |url=https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html |access-date=2022-03-22 |issn=0362-4331}}</ref><ref>{{Cite web |last=Lovelace |first=Berkeley Jr. |date=2021-07-09 |title=Biogen stock falls after FDA calls for federal investigation into Alzheimer's drug approval |url=https://www.cnbc.com/2021/07/09/biogen-alzheimers-drug-fda-calls-for-federal-investigation-into-approval.html |access-date=2022-03-22 |website=CNBC |language=en}}</ref> The drug was priced at $56,000 US dollars per year, but it was not covered by many insurers as they awaited further proof that the drug was effective.<ref>{{Cite web |last=King |first=Robert |date=2021-11-22 |title=Major insurers won't pay for Biogen's Alzheimer's drug until they get more proof that it works: Bloomberg survey |url=https://www.fiercehealthcare.com/payer/bloomberg-survey-major-insurers-question-if-controversial-alzheimer-s-drug-medically |access-date=2022-03-22 |website=Fierce Healthcare |language=en}}</ref> The US Government did not subsidise it outside clinical trials.<ref>{{Cite web |last=Liu |first=Angus |date=2022-01-12 |title=For Biogen's Aduhelm, narrow coverage from CMS 'could effectively spell the end': analyst |url=https://www.fiercepharma.com/marketing/biogen-alzheimer-s-drug-aduhelm-cms-restrictive-draft-reimbursement-ruling-could |access-date=2022-03-22 |website=Fierce Pharma |language=en}}</ref> According to the FDA's website, the drug was proven to reduce amyloid-beta plaques in the brain, which was likely to benefit patients. The FDA has stated that if the post-approval trial did not indicate that Aduhelm works, the drug may be taken out of the market.<ref>{{Cite news|last1=Steenhuysen|first1=Julie|last2=Beasley|first2=Deena|date=2021-06-08|title=U.S. approval of Biogen Alzheimer's drug sends shares soaring, hailed as 'big day" for patients|language=en|work=Reuters|url=https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-set-rule-controversial-biogen-alzheimers-drug-2021-06-07/|access-date=2021-10-11}}</ref> Biogen abandoned the drug in January 2024, for financial reasons.<ref>{{Cite web |title=Biogen will stop selling its controversial Alzheimer's drug Aduhelm |url=https://abcnews.go.com/Health/wireStory/biogen-plans-shut-controversial-alzheimers-drug-aduhelm-106827709 |access-date=2024-02-01 |website=ABC News |language=en}}</ref>
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