BioSpace News Archive

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  GLP-1

  Evidence Mounts for Potential of GLP-1s in Alzheimer’s Disease

  The darlings of the weight loss and diabetes spaces, GLP-1 receptor agonists have shown promise against Alzheimer’s in recent studies—with Phase III results expected next year from Novo Nordisk.

  December 9, 2024

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  6 min read

   · 

  Heather McKenzie
• 

  Regulatory

  FDA Action Alert: Ionis, Lexicon, Bristol Myers Squibb and More

  The FDA’s year-end rush includes nine target action dates, mostly for rare disease and cancer therapies.

  December 9, 2024

   · 

  7 min read

   · 

  Tristan Manalac
• 

  Mergers & acquisitions

  Novo, Catalent $16.5B Deal Wins EU Blessing as US Antitrust Scrutiny Mounts

  In the U.S., the chorus of opposition against the proposed buyout continues to grow and now includes the CEOs of Roche and Lilly, a broad coalition of unions and consumer groups and at least one senator.

  December 9, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Lymphoma

  Merck Touts 100% Complete Response Rate for Anti-ROR1 ADC as First-Line Lymphoma Treatment

  Analysts called the data “very competitive” but raised questions about safety. Merck gained ownership of the ADC when it acquired VelosBio in November 2020 for $2.75 billion.

  December 9, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Partnered

  The Strategic Imperative: Why Early Potency Assay Development Makes or Breaks ATMP Success

  Not developing potency assays and gaining knowledge about MOAs early in the drug development process not only can break ATMP success but can cause costs and delays that lead to company closures.
  

  December 9, 2024

   · 

  7 min read

   · 

  BioSpace Insights
• 

  Parkinson’s disease

  A Month After Stunning Schizophrenia Fail, AbbVie’s Other Cerevel Asset Shines Again

  Tavapadon improved motor and daily living complications at week 26. The news comes nearly one month to the day after AbbVie announced the Phase II failure of another key Cerevel asset, emraclidine.

  December 9, 2024

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  1 min read

   · 

  Annalee Armstrong
• 

  Opinion

  What Accelerated Approval’s Naysayers Miss

  By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives.

  December 9, 2024

   · 

  5 min read

   · 

  Emil Kakkis
• 

  Obesity

  BioAge Crashes After Axing Phase II Obesity Study

  The discontinuation of STRIDES is a rare stumble for the next-generation obesity field and comes just weeks after Amgen announced underwhelming mid-stage data for MariTide.

  December 9, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Sickle cell disease

  Vertex, Beam Report SCD Cell and Gene Therapies Advances at ASH 2024

  Vertex unveiled long-term durability data for Casgevy, while Beam presented Phase I/II findings for its investigational base editor BEAM-101, building up to a BLA by late 2026.

  December 9, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Depression

  Relmada Considering ‘Strategic Alternatives’ After Failure of Depression Asset

  Relmada Therapeutics will halt two Phase III trials of a major depressive disorder drug after a futility assessment and explore strategic alternatives including a potential sale to maximize shareholder value.

  December 9, 2024

   · 

  1 min read

   · 

  Heather McKenzie