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BioCentury | Feb 7, 2025
Discovery & Translation

Science Spotlight: New protein degradation mechanism

BioCentury’s roundup of translational innovations also includes new insight into repeat expansion in Huntington’s and 10 new products
BioCentury | Jul 10, 2024
Product Development

Clinical Report: uniQure’s Huntington readout, Ideaya’s MAT2A data drive shares up

Plus: A HilleVax vaccine disappoints, and another TIGIT miss for Genentech
BioCentury | Jun 26, 2024
Product Development

Clinical Report: Metabolic readouts from Innovent, Zealand, Poltreg

Plus: New data from Wave, G1 and Jazz
BioCentury | May 22, 2024
Product Development

Clinical Report: GSK records asthma win

Plus: Data from Amgen-AstraZeneca, Biogen-Ionis and more
BioCentury | May 21, 2024
Discovery & Translation

Big data for a rare disease: FNIH takes on ALS

In partnership with FDA, industry and disease foundations, FNIH is creating a one-stop shop for data on the rare disease to spur diagnostics and therapeutics development 
BioCentury | Apr 26, 2023
Regulation

With tofersen approval, neurofilament becomes ‘anchor’ biomarker in ALS

In ascending to the ranks of surrogate endpoint, NfL stands to galvanize ALS clinical trials and accelerate validation of the next biomarkers
BioCentury | Mar 27, 2023
Finance

VCs’ take on SVB, plus a new surrogate endpoint for ALS

Assessing results from BioCentury’s survey of VCs on the collapse of SVB, and analysis of FDA’s tofersen panel and draft guidance on accelerated approval 
BioCentury | Mar 23, 2023
Regulation

Tofersen panel bolsters case for neurofilament as ALS surrogate endpoint 

FDA advisory committee backs accelerated approval of Biogen therapy, but rejects full approval
BioCentury | Mar 21, 2023
Regulation

ALS panel to weigh accelerated vs. full approval of Biogen’s tofersen

FDA proposing two paths to regulatory flexibility; one would establish NfL as a surrogate endpoint for the disease
BioCentury | Feb 28, 2023
Regulation

How much will Dunn’s influence persist as he departs FDA?

18-year veteran of agency a strong advocate for regulatory flexibility as head of Office of Neuroscience  
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