№ lp_1_2_37097
File format: docx Character count: 87595 File size: 482 KB
Year: 2017
Region / City: Australia
Subject: Spinal Muscular Atrophy (SMA) Treatment
Document Type: Clinical Submission
Organ / Institution: Biogen Australia Pty Ltd
Author: Biogen Australia Pty Ltd
Target Audience: Healthcare Professionals, Regulatory Authorities
Period of Validity: Ongoing (from 2017 onwards)
Approval Date: 2 November 2017
Date of Changes: July 2020
Background: TGA registered
Registration Status: TGA registration for SMA treatment
Previous Consideration: PBAC submission history
Clinical Claim: Nusinersen is superior for pre-symptomatic SMA treatment with 3 SMN2 copies
Contextual Description: This document outlines a clinical resubmission requesting a Section 100 Authority Required listing for the pre-symptomatic treatment of SMA with nusinersen for individuals with 3 SMN2 copies, aged under 18 years.
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Nusinersen, an exon 7 inclusion drug for spinal muscular atrophy: A minireview
Year: 2021
Region / city: Chandigarh, India
Theme: Spinal muscular atrophy, Nusinersen, Neurology
Document Type: Minireview
Organization / Institution: Chaitanya Hospital, Department of Neonatology
Author: Bijaylaxmi Behera
Target Audience: Healthcare professionals, researchers in neurology
Period of Validity: Not specified
Date of Approval: June 17, 2021
Date of Changes: Not specified
NATALIZUMAB, Injection 150 mg in 1 mL single dose pre-filled syringe, Tysabri®, Biogen Australia Pty Ltd
Year: 2021
Category: Category 4 Submission
Type of Document: Submission for PBS Listing
Therapeutic Area: Multiple Sclerosis
Indication: Clinically definite relapsing-remitting multiple sclerosis
Medical Condition: Multiple Sclerosis
Prescriber Type: Medical Practitioners
Restriction Type: Authority Required (Streamlined)
Prescribing Instructions: To be initiated by neurologists, monitoring for signs of progressive multifocal leukoencephalopathy
Comparison: Natalizumab IV, Ofatumumab
Status: Approved for listing
Clinical Trials: REFINE, DELIVER
Treatment Duration: Ongoing monitoring
Approval: Therapeutic Goods Administration (TGA) approval on 7 December 2021
Public/Private: Both Public and Private
Available Brands: Tysabri
Method of Administration: Subcutaneous injection
Intended Use: Subcutaneous administration of natalizumab for multiple sclerosis
Safety Warnings: Risk of progressive multifocal leukoencephalopathy
NATALIZUMAB, Solution concentrate for I.V. infusion 300 mg in 15 mL, Tysabri®, Biogen Australia Pty Ltd
Year: 2021
Region / City: Australia
Topic: Pharmaceutical regulation and prescribing requirements
Document Type: Regulatory submission
Organization: Biogen Australia Pty Ltd
Author: Biogen Australia Pty Ltd
Target Audience: Medical practitioners, healthcare professionals
Action Period: 2021-2022
Approval Date: 31 August 2020
Modification Date: 7 September 2021
Status: Approved by TGA
Context: This is a regulatory submission regarding changes to the prescribing instructions for natalizumab (Tysabri®) under the PBS, specifically the removal of mandatory registration with the Tysabri Australian Prescribing Program.
Statement of Changes in Beneficial Ownership for Biogen Inc., February 2026
Year: 2026
Region / City: Cambridge, MA, United States
Document Type: SEC Form 4
Issuer: Biogen Inc.
Reporting Person: Adam Keeney
Position: Head of Corporate Development
Transaction Dates: 02/06/2026
Securities Involved: Common Stock, Restricted Stock Units
Filing Date: 02/10/2026
Form Purpose: Reporting changes in beneficial ownership under Section 16(a) of the Securities Exchange Act of 1934
Signature: Wendell Taylor, attorney-in-fact
Topics: Spinraza NUSINERSEN Biogen