BioSpace News Archive

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  Policy

  FDA Adcomm Backs Geron’s Anemia Drug for Blood Cancer

  Despite skepticism from FDA reviewers, the Oncologic Drugs Advisory Committee on Thursday strongly supported Geron’s imetelstat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes.

  March 15, 2024

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  2 min read

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  Tristan Manalac
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  Business

  Bayer, AI-Focused Aignostics Partner to Find New Oncology Targets

  Bayer will co-create a novel target identification platform that leverages Aignostics’ artificial intelligence technology and proprietary multimodal patient cohorts.

  March 15, 2024

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  2 min read

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  Tyler Patchen
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  Policy

  FDA Adcomm Backs J&J’s Carvykti, BMS’s Abecma Early in Multiple Myeloma

  By votes of 11-0 and 8-3, respectively, an FDA advisory committee Friday deemed the risks of early death for both Johnson & Johnson’s Carvykti and Bristol Myers Squibb’s Abecma acceptable.

  March 15, 2024

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  4 min read

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  Tyler Patchen
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  FDA

  NASH or MASH: No Matter What You Call It, Madrigal’s FDA Approval Is a Big Deal

  If you’re confused by the NASH versus MASH indication, you’re not alone.

  March 15, 2024

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  3 min read

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  Greg Slabodkin
• 

  FDA

  BMS’s Breyanzi Becomes First CAR-T Therapy for Two Types of Leukemia

  The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.

  March 15, 2024

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  5 min read

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  Heather McKenzie
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  Business

  Astellas Backs Out of Potential $340M Licensing Deal with Cartesian

  After forging a partnership last year, Astellas is ending the pact with Cartesian Therapeutics and stopping the development of a Pompe disease candidate.

  March 15, 2024

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  2 min read

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  Tyler Patchen
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  Business

  Biotheus, Hansoh Expand Partnership in $694M ADC Deal

  The Chinese biotechs are broadening their collaboration. Hansoh Pharma is licensing Biotheus’ anti-EGFR/cMet bispecific antibody to develop antibody-drug conjugates.

  March 15, 2024

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  2 min read

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  Tyler Patchen
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  Drug Development

  Asgard Gets $32M Series A Backing from J&J, Novo and Boehringer

  Asgard Therapeutics, a Swedish gene therapy biotech, has closed a $32 million Series A round with help from prominent pharma players as it prepares for a 2026 IND.

  March 15, 2024

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  2 min read

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  Tyler Patchen
• 

  FDA

  BeiGene’s Tevimbra Wins First US Approval Following Tough Regulatory Path

  After several delays, BeiGene on Thursday finally secured the FDA’s approval for its PD-1 inhibitor Tevimbra for the treatment of unresectable or metastatic esophageal squamous cell carcinoma.

  March 15, 2024

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  2 min read

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  Tristan Manalac
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  Drug Development

  Merck’s Keytruda Pushes Towards Earlier Stages of Cervical Cancer with Phase III Data

  The PD-1 inhibitor Keytruda significantly improved overall survival in a late-stage trial when used with chemoradiotherapy to treat patients with newly diagnosed advanced cervical cancer.

  March 15, 2024

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  2 min read

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  Tristan Manalac