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Biogen Inc (BIIB.O)

BIIB.O on Nasdaq

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18 Jan 2017
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Latest Key Developments (Source: Significant Developments)

Biogen's regulatory applications for nusinersen as a treatment for spinal muscular atrophy accepted by FDA, EMA
Friday, 28 Oct 2016 07:30am EDT 

Biogen Inc : Biogen's regulatory applications for nusinersen as a treatment for spinal muscular atrophy accepted by FDA and EMA . Biogen's regulatory applications for nusinersen as a treatment for spinal muscular atrophy accepted by FDA and EMA . Says nusinersen granted priority review by FDA . Biogen Inc - EMA plans to follow accelerated assessment timeline for nusinersen . Biogen Inc - Biogen exercised its option to worldwide rights to nusinersen in august 2016 . Says intends to market nusinersen under brand name spinraza .Says is initiating regulatory filings in other countries in coming months.  Full Article

Anavex signs material transfer agreement with Biogen
Wednesday, 28 Sep 2016 07:00am EDT 

Anavex Life Sciences :Signed material transfer agreement with Biogen under which Biogen will test Anavex's lead drug candidate, Anavex 2-73.  Full Article

Biogen completes submission of new drug application
Monday, 26 Sep 2016 07:30am EDT 

Biogen Inc : Biogen completes rolling submission of new drug application to FDA for nusinersen as a treatment for spinal muscular atrophy . Biogen completes rolling submission of new drug application to FDA for nusinersen as a treatment for spinal muscular atrophy . Submission of marketing authorization application to European medicines agency planned in coming weeks .Has also applied for priority review for nusinersen.  Full Article

BioMotiv and Biogen expand strategic partnership
Tuesday, 6 Sep 2016 07:05am EDT 

Biogen Inc :BioMotiv and Biogen expand strategic partnership into ophthalmology.  Full Article

Biogen's Aducanumab granted FDA fast track designation
Thursday, 1 Sep 2016 04:20pm EDT 

Biogen Inc : Biogen's investigational alzheimer's disease treatment Aducanumab granted FDA fast track designation . Biogen's investigational alzheimer's disease treatment Aducanumab granted FDA fast track designation . Biogen Inc says Aducanumab is currently being evaluated in two global phase 3 studies . Biogen Inc says in a recently completed interim analysis from prime, efficacy and safety data were consistent with results previously reported .Biogen Inc says data support design of ongoing phase 3 engage and emerge studies.  Full Article

Allergan has no interest in a Biogen deal - CNBC, citing sources
Wednesday, 3 Aug 2016 09:38am EDT 

:Allergan has no interest in a Biogen deal - CNBC, citing sources.  Full Article

Amyris enters partnership with Biogen
Wednesday, 3 Aug 2016 08:30am EDT 

Amyris Inc : Collaboration will explore use of Amyris's microbe engineering technology .Amyris enters partnership with Biogen to develop alternative cell lines supporting production of therapeutics.  Full Article

Allergan unlikely to pursue Biogen deal- CNBC,citing source
Tuesday, 2 Aug 2016 04:15pm EDT 

: Allergan unlikely to pursue Biogen deal- CNBC,citing source (Bengaluru Newsroom: +1-646-223-8780).  Full Article

Biogen has drawn takeover interest from drug companies including Merck & Co and Allergan - WSJ
Tuesday, 2 Aug 2016 02:47pm EDT 

: Biogen has drawn takeover interest from drug companies including Merck & Co and Allergan Plc- WSJ, citing sources Source (http://on.wsj.com/2b0s6q9) (Bengaluru Newsroom: +1-646-223-8780).  Full Article

Biogen and Ionis say Nusinersen meets primary endpoint at interim analysis of phase 3 Endear study
Monday, 1 Aug 2016 07:30am EDT 

Biogen Inc : Biogen Inc And Ionis Pharmaceuticals Report Nusinersen Meets Primary Endpoint At Interim Analysis Of Phase 3 Endear Study In Infantile Onset spinal muscular atrophy . Biogen exercises option to develop and commercialize Nusinersen globally . Infants receiving Nusinersen experienced a statistically significant improvement in achievement of motor milestones versus those who didn't . Biogen is now responsible for all Nusinersen development, regulatory and commercialization activities and costs. . Ionis will complete phase 3 studies and work with Biogen on regulatory filings for Nusinersen . Intends to file marketing applications for Nusinersen with regulatory authorities in coming months . Biogen has exercised its option to develop and commercialize Nusinersen globally and paid Ionis a $75 million license fee . Ionis is eligible to receive tiered royalties on any potential sales of Nusineren up to a percentage in mid-teens .Ionis is eligible to receive up to $150 million in milestone payments based on regulatory approvals for nusinersen.  Full Article

Biogen to pay Forward Pharma $1.25 bln to protect MS drug

Biogen Inc said on Tuesday it would pay Forward Pharma A/S $1.25 billion to license the Danish company's patents covering multiple sclerosis drugs, providing Biogen an insurance policy on future sales of Tecfidera, its blockbuster oral treatment for the disease.