Biogen

This sponsor has funded 24 studies across 32 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
3976 Finalised Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry Yes Yes
6782 Finalised A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate)... Yes Yes
7193 Ongoing German Tysabri-Data-Register (Tysabri-Register) No No
9336 Finalised A Retrospective, Multi-Center, Observational Study to Assess the Effect of Tecfidera® Delayed-Release Capsules on Lymphocyte Subsets in Subjects with... Yes Yes
13054 Finalised EPID Multiple Sclerosis Pregnancy study - Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon beta - a... Yes Yes
19800 Ongoing An observational study utilising data from the US Tysabri TOUCH programme and select EU MS Registries to estimate the risk of progressive multifocal... No No
21013 Finalised Subcutaneous Interferon beta therapy in multiple sclerosis patients and characterization of injection site reactions and flu-like symptoms under daily... No Yes
21305 Finalised Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany Yes Yes
27459 Finalised Plegridy™ (peginterferon β 1a) Real World Effectiveness and Safety Observational Program (POP) Yes Yes
28367 Finalised A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In... Yes Yes
28580 Ongoing TOP: Tysabri® Observational Program No No
28904 Finalised TyPed - Natalizumab for the treatment of pediatric-onset multiple sclerosis in Portugal Yes Yes
28923 Finalised JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri: STRATIFY-2 Yes Yes
28992 Finalised A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA Yes Yes
32033 Planned Metabolic Profiling of Neuromuscular Diseases (MetabNMD) – subproject SMA No No
38347 Finalised Non-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a... Yes Yes
39505 Ongoing A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management... No No
43860 Finalised Incidence of Aicardi-Goutières syndrome (AGS) and KCNT1-related epilepsy in Denmark Yes Yes
44059 Ongoing OPTIMISE:MS A Prospective, Real World Pharmacovigilance Study in Multiple Sclerosis Yes No
45445 Ongoing Long-term surveillance of patients with multiple sclerosis to report progressive multifocal leukoencephalopathy and other serious opportunistic... No No
48753 Ongoing An Observational Study Utilising Data from EU National MS Registries to Estimate the Incidence of Anti-Natalizumab Antibody Among Patients Who Receive... No No
104368 Planned Spinraza (nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries No No
106453 Planned Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry No No
106690 Finalised An Observational, Cross-Sectional Survey to Assess PML Risk Awareness and Understanding from Patients’ Perspective and Effectiveness of the Tysabri... Yes No

PAS by Risk Management Plan (RMP) requirement

Biogen

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.