BioSpace News Archive

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• 

  Regulatory

  Deep Dive: FDA’s Accelerated Approval Pathway Under Fire

  In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.

  November 18, 2024

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  2 min read

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  Heather McKenzie
• 

  Gene editing

  Intellia’s CRISPR Gene Editor Shows Early Promise With Strong Biomarker Benefit in ATTR Amyloidosis

  Analysts appear optimistic for Intellia’s gene editor nex-z, which showed a greater serum TTR reduction than Alnylam’s Amvuttra.

  November 18, 2024

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  3 min read

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  Tristan Manalac
• 

  Gene therapy

  Neurogene Details Gene Therapy Complication, Sending Shares Plummeting Again

  Neurogene’s shares fell by 36% as the market opened Monday morning following news that a patient experienced systemic hyperinflammatory syndrome in a Phase I/II clinical trial of Rett syndrome gene therapy NGN-401.

  November 18, 2024

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  2 min read

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  Annalee Armstrong
• 

  Radiopharma

  Novartis Drops Up to $745M to Move Deeper Into Competitive Radiopharma Space

  The deal has secured Novartis the chance to work with Ratio Therapeutics on a novel drug candidate that could fortify the Big Pharma against competition from would-be radiopharmaceutical rivals such as BMS and Lilly.

  November 18, 2024

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  2 min read

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  Nick Paul Taylor
• 

  Editorial

  AbbVie’s Setback Gives BMS Commanding Lead in Schizophrenia Space

  With the failure of AbbVie’s emraclidine in two mid-stage trials, Bristol Myers Squibb’s Cobenfy is ‘sole muscarinic winner.’

  November 18, 2024

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  5 min read

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  Heather McKenzie
• 

  MASH

  Boston Pharma Carves Out Monthly Treatment Niche in MASH With Strong Phase II Data

  Boston Pharma’s once-monthly injection efimosfermin alfa offers a convenient dosing option for MASH patients while also achieving promising rates of fibrosis and MASH improvement, according to a Phase II readout.

  November 18, 2024

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  2 min read

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  Tristan Manalac
• 

  Sponsored

  SignalChem’s Tau Proteins: Accelerating Neurodegenerative Disease Research

  SignalChem Biotech provides diverse recombinant Tau proteins for research, helping advance tau-targeted therapies that may modify disease progression in Alzheimer’s and related tauopathies.

  November 18, 2024

   · 

  3 min read
• 

  Weight loss

  Novo’s Wegovy Launched in China at a Fraction of US Price

  Wegovy is being made available to Chinese patients five months after its approval in the country. Novo will sell the medicine for about $193.27 for a one-month supply.

  November 18, 2024

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  1 min read

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  Annalee Armstrong
• 

  Psychedelics

  Cybin’s Small Depression Study Shows 71% Remission Rate

  Phase II results for Cybin’s psilocin therapy showed remission rates of 71%, but just eight patients made it to the 12-month milestone.

  November 18, 2024

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  2 min read

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  Annalee Armstrong
• Press Releases

  Opthea Appoints Kathy Connell to Board of Directors

  November 18, 2024

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  6 min read