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Full Name:Biogen Idec Inc. Industry:biological products (diagnostic and non diagnostic) CIK:875045 Fiscal Year End:12-31 State/Country:MASSACHUSETTS

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US clinical trial status

Size of symbol reflects the phase of clinical trial. E.g. Phase 3 trial has the largest size.
Shape definition
Up-triangle: study first submitted.
Square: study completion(actual/anticipated).
Circle: result first posted.
Color definition
Green: study is ongoing.
Blue: recruitment completed.
Red: study aborted/terminated/withdrawn.
Pink: study in abnormal state.

US FDA submission

Size of symbol reflects the type of submission. E.g. Type 1 drug has the largest size.
: Approved.
: Tentative Approval.

Drug marketing & current status

Circle bubble denotes new drug marketing. Size is determined by drug type and market(i.e. population) size. E.g. Type 1 drug marketed in US has the largest size. Drug marketed in CA has the smallest size due to small population size.
Color definition
Blue circle: drug marketed (EU,CA), FDA submission approved (US).
Cyan circle: drug approved (CA), tentative approval (US), received positive opinion (EU)
Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.

Drug marketing status change

Square bubble denotes marketing status change. Size is determined by drug type and market(i.e. population) size.
Color definition
Blue square: change from other status to marketed.
Cyan square: change from other status to tentative status.
Red square: change from other status to abnormal or withdrawn status.

US Clinical Trials

Clinical Trials Summary Statistics

Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 2
2024
2023
2022
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 2 2 2 127 17 2
2024 1 1 1
2023 1 2
2022 1 3
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 1 8 4 1
2024
2023
2022
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 4 2 57 24 7
2024
2023 1 1
2022 3
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 1 2
2024
2023
2022 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 6 4 6 41 24 3
2024
2023 1
2022 1 2 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 1 1 27 6 6
2024
2023
2022 1 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 1 2
2024
2023
2022 1
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 2 4 1 6 1 1
2024 1
2023 1
2022 1 3 1 1 1
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 4
2024
2023 1
2022 1
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 2 1 2 6 1
2024 1
2023
2022 2
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 2
2024 1
2023 1
2022
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 2 127 8 57 2 41 27 2
2024
2023 2
2022 3
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 17 4 24 24 6
2024
2023
2022 1 1
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 2 1 7 3 6
2024
2023 1
2022
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Early Phase 1 2
Phase 1 2 2 2 127 17 2
Phase 1|Phase 2 1 8 4 1
Phase 2 4 2 57 24 7
Phase 2|Phase 3 1 2
Phase 3 6 4 6 41 24 3
Phase 4 1 1 27 6 6
Others 1 2
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Early Phase 1
Phase 1 1 1 1
Phase 1|Phase 2
Phase 2
Phase 2|Phase 3
Phase 3
Phase 4
Others
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Early Phase 1
Phase 1 1 2
Phase 1|Phase 2
Phase 2 1 1
Phase 2|Phase 3
Phase 3 1
Phase 4
Others
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Early Phase 1
Phase 1 1 3
Phase 1|Phase 2
Phase 2 3
Phase 2|Phase 3 1
Phase 3 1 2 1
Phase 4 1 1
Others 1

Note: "Year" represents clinical trail start year determined by study first submit date.
Three grouping strategies present the same statistical data from different angles, choose any one you are comfortable with.
at least one study with latest update posted within 7 days.  at least one study with latest update posted within 30 days.  at least one study with latest update posted within 90 days. 

Clinical Trials Records

Sponsor Overall Status Phase Brief Title Disease Condition Intervention Name Study First Submit Date Last Update Post Date Results First Post Date Completion Date Completion Date Type Enrollment Count
Biogen Enrolling by invitation Phase 3 A Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Subacute Cutaneous Lupus Erythematosus (CLE) and/or Chronic CLE With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy Subacute Cutaneous Lupus Erythematosus|Chronic Cutaneous Lupus Erythematosus BIIB059 (litifilimab) 2023-08-23 2024-04-26 2029-12-11 Anticipated 322
Biogen Recruiting Phase 2|Phase 3 A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy Subacute Cutaneous Lupus Erythematosus|Chronic Cutaneous Lupus Erythematosus BIIB059 (litifilimab)|Placebo 2022-08-19 2024-04-22 2026-12-13 Anticipated 474
Biogen Terminated Phase 3 A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Parkinson Disease BIIB122|BIIB122-Matching Placebo 2022-06-10 2023-12-20 2023-07-27 Actual 7
Biogen Enrolling by invitation Phase 3 A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE) Litifilimab|Litifilimab-matching placebo 2022-04-25 2024-04-26 2029-03-13 Anticipated 864
Biogen Active, not recruiting Phase 3 A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease Alzheimer's Disease Aducanumab|Placebo 2022-03-25 2024-02-12 2026-10-31 Anticipated 1512
Biogen Active, not recruiting Phase 3 A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Natalizumab 2022-02-23 2024-02-21 2024-06-06 Anticipated 21

Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "phase 3" (case insensitive, with double quote) to show Phase 3 trials.
latest update posted within 7 days.  latest update posted within 30 days.  latest update posted within 90 days. 

US FDA Submissions

US FDA Submission Summary Statistics*

Year TYPE 1 TYPE 2 UNKNOWN
ALL 8 1 1
2024
2023 1 1
2022

Note: "Year" determined by submission status date.
* Original submissions only. Supplementary records not counted.
at least one submission within 7 days.  at least one submission within 30 days.  at least one submission within 90 days. 

US FDA Submission Records

Sponsor Application Type Drug Name Active Ingredient Submission Code Submission Type Submission Status Status Date Application Number
Biogen Inc NDA Zurzuvae Zuranolone Orig 2 Approval 2023-08-04 217369
Biogen Ma BLA Tofidence Tocilizumab Bavi Unknown Orig Approval 2023-09-29 761354
Biogen Ma NDA Qalsody Tofersen Type 1 Orig Approval 2023-04-25 215887

Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "NDA" (case insensitive) to show records with "NDA" (New Drug Applications) tag.
submission status date within 7 days.  submission status date within 30 days.  submission status date within 90 days. 

US Drug Marketing Status
Category Sponsor Marketing Date Current Marketing Status Drug Name Active Ingredient Submission Status Date Submission Code Submission Status Marketing Status Change Date
Human Non-Bioproduct Biogen Ma 2023-09-29 Prescription Tofidence Tocilizumab Bavi 2023-09-29 Unknown Approval 2023-11-30
Human Non-Bioproduct Biogen Ma 2023-04-25 Prescription Qalsody Tofersen 2023-04-25 Type 1 Approval 2023-11-30
Human Bioproduct Biogen Idec, Inc. NA Marketed Eloctate Antihemophilic (Recombinant), Fc Fusion Protein

Note: This table contains human and animal drugs regulated by US FDA, and biological products regulated by CBER (Center for Biologics Evaluation and Research).
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "discontinued" (case insensitive) to show discontinued drug products.
For human non-bioproduct, marketing date was set to submission approval date.
Possible marketing statuses: Marketed, Prescription, Over-the-counter, Discontinued, None (Tentative Approval).
any of (marketing/submission/status change) within 7 days.  any of (marketing/submission/status change) within 30 days.  any of (marketing/submission/status change) within 90 days. 

EU Drug Marketing Status
Category Sponsor Authorization Date Current Marketing Status Latest Status Update Drug Name Active Ingredient Withdraw Date Opinion Date Summary of Opinion
Human Biogen Netherlands B.V. Withdrawn Aduhelm, Aducanumab 2022-04-20

Note: This table contains human and animal drugs regulated by EMA (European Medicines Agency), and summary of opinion published by EMA based on the CHMP's or CVMP's positive or negative recommendation.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "withdrawn" (case insensitive) to show drugs withdrawn.
Possible marketing statuses: Authorised, Refused, Withdrawn, Summary of Opinion.
Summary of Opinion: published by European Medicines Agency (EMA) based on the CHMP's or CVMP's positive or negative recommendation. Further marketing authorization is partially based on this opinion.
any of (authorization/withdrawn/opinion/status change) date within 7 days.  any of (authorization/withdrawn/opinion/status change) date within 30 days.  any of (authorization/withdrawn/opinion/status change) date within 90 days. 

CA Drug Marketing Status

No marketed drug found matching current filtering criteria

Note: This table contains human, animal drugs, radiopharmaceutical and disinfectant regulated by CFIA(Canadian Food Inspection Agency) and Health Canada.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "marketed" (case insensitive) to show drugs marketed.
Possible marketing statuses: Marketed, Approved, Dormant, Cancelled Pre Market, Cancelled Post Market, Cancelled (Safety Issue), Cancelled (Unreturned Annual).
any of (authorization/status change) date within 7 days.  any of (authorization/status change) date within 30 days.  any of (authorization/status change) date within 90 days.