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House Committees to Investigate New Alzheimer Disease Drug Approval drugs
July 02, 2021
The U.S. Food and Drug Administration's controversial approval of a new drug for Alzheimer disease, along with its high price, is now being investigated by two House committees.
FDA grants breakthrough status to Eisai and Biogen’s Alzheimer’s drug pharmaceutical-technology
June 25, 2021
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eisai and Biogen’s lecanemab (BAN2401) for Alzheimer’s disease (AD) treatment.
Alzheimer’s Drug Price Uproar Grows as U.S. Weighs Coverage firstwordpharma
June 23, 2021
The $56,000 annual price tag for Biogen and Eisai's Aduhelm is drawing increasing criticism ahead of a US government decision on reimbursement policies for the recently approved Alzheimer's disease drug, reported Bloomberg.
Biogen’s inherited eye disease gene therapy misses the mark in late-stage trial pharmatimes
June 17, 2021
Biogen has announced that a late-stage trial of its gene therapy timrepigene emparvovec did not meet its primary and key secondary endpoints in patients with the rare inherited eye disease choroideremia.
Biogen Welcomes NICE Announcement on TA375 as a Landmark Decision for UK Patients with Moderate Rheumatoid Arthritis firstwordpharma
June 11, 2021
Biogen UK welcomes the decision by the National Institute for Health and Care Excellence (NICE) to broaden patient access to biologics, including biosimilars, to treat moderate rheumatoid arthritis (RA).
Biogen gets US FDA accelerated approval for Aduhelm to treat Alzheimer’s expresspharma
June 09, 2021
It is the first new treatment approved for Alzheimer's since 2003 and is the first therapy that targets the fundamental pathophysiology of the disease.
Biogen partners with Ginkgo Bioworks on gene therapy manufacturing platform pharmatimes
May 25, 2021
Biogen has entered into a new collaboration with Ginkgo Bioworks to develop a novel gene therapy manufacturing platform to ‘redefine the industry standard’ for manufacturing AAV-based vectors.
Biogen’s inherited eye disease gene therapy misses primary endpoint pharmatimes
May 17, 2021
A gene therapy developed by Biogen for the rare inherited eye disease X-linked retinitis pigmentosa (XLRP) has failed to meet the primary endpoint in a Phase II/III study.
NICE expands access for SMA drug Spinraza pharmatimes
May 07, 2021
The UK’s National Institute for Health and Care Excellence (NICE) has extended the clinical eligibility criteria for Biogen’s spinal muscular atrophy (SMA) drug Spinraza following a review of data collected as part of a managed access agreement (MAA).
New subcutaneous formulation of Tysabri approved in UK pharmatimes
April 19, 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new subcutaneous (SC) formulation for Biogen’s multiple sclerosis treatment Tysabri.

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