BioSpace News Archive

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  Editorial

  FDA’s Accelerated Approval Pathway Drives Momentum for Intractable, Fatal Diseases

  Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track record of propelling R&D for some of medicine’s most challenging illnesses.

  December 2, 2024

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  6 min read

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  Heather McKenzie
• 

  Huntington’s disease

  Novartis Pays Up to $2.9B in Huntington’s Deal With PTC

  Monday’s agreement comes days after PTC discontinued the development of another asset, utreloxastat, due to disappointing Phase II data in amyotrophic lateral sclerosis.

  December 2, 2024

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  2 min read

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  Tristan Manalac
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  Brain cancer

  Biopharma Takes on Deadly Brain Cancer After Decades of Failure

  Emboldened by technological advances and a deeper knowledge of glioblastoma, Merck, Kazia Therapeutics, CorriXR Therapeutics and others are targeting the often-fatal brain tumor.

  December 2, 2024

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  7 min read

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  Kate Goodwin
• 

  Artificial intelligence

  Digital Twins Could Augment Clinical Research, Help Ease Data Disparities

  Projected to be worth over $38 billion in the global healthcare market by 2032, AI simulations have the potential to streamline clinical trials and help address inequities in underserved patient populations.

  December 2, 2024

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  6 min read

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  Joanna Smiley
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  Gene therapy

  Bluebird’s Gene Therapy Skysona Under FDA Safety Probe for Hematologic Malignancies

  The cancers were diagnosed 19 to 92 months after Skysona treatment.

  December 2, 2024

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  2 min read

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  Tristan Manalac
• 

  Cancer

  AstraZeneca/Daiichi Sankyo, BioNTech, Merus to Present Promising Cancer Therapies at ESMO Asia 2024

  At the conference, AstraZeneca and Daiichi Sankyo will present their case for Dato-DXd in NSCLC, while BioNTech and Merus will reveal promising mid-stage data for their respective cancer candidates.

  December 2, 2024

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  4 min read

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  Tristan Manalac
• 

  Complete response letters

  Applied Therapeutics Crashes After FDA Rejection of Rare Disease Drug

  After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.

  December 2, 2024

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  3 min read

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  Tristan Manalac
• Press Releases

  Nicox’s Denali Phase 3 Trial of NCX 470 Fully Enrolled in China Earlier than Expected

  December 2, 2024

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  6 min read
• Press Releases

  AAVantgarde Bio Announces FDA Orphan Drug Designation for AAVB-081 for the Treatment of Usher Syndrome Type 1B Retinitis Pigmentosa

  December 2, 2024

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  2 min read
• Press Releases

  Senti Bio Appoints Fran Schulz to Board of Directors

  December 2, 2024

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  8 min read