BioSpace News Archive

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• 

  GLP-1

  Novo’s Wegovy Inches Closer to Becoming First FDA-Approved GLP-1 Weight-Loss Pill

  The FDA accepted Novo Nordisk’s NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the drug in the fourth quarter of this year.

  May 5, 2025

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  2 min read

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  Tristan Manalac
• 

  Earnings

  BioNTech’s Ambitious PD-L1/VEGF Plans Currently Rely on Chinese Manufacturing

  BNT327, a PD-L1/VEGF therapy, is still currently being manufactured in China, but BioNTech is working to establish a diversified supply chain, executives said during the company’s Q1 investor call.

  May 5, 2025

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  3 min read

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  Tristan Manalac
• 

  Regulatory

  FDA Action Alert: GSK, Sanofi, Merck and More

  On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.

  May 5, 2025

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  6 min read

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  Tristan Manalac
• 

  Huntington’s disease

  PTC Nosedives Despite Claiming Phase II Win for Huntington’s Hopeful

  The biotech’s Huntingtin-targeting molecule lowered blood levels of the protein and elicited functional improvements in earlier-stage patients, but results were not as robust in other biomarkers or with patients at later stages of the disease.

  May 5, 2025

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  2 min read

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  Dan Samorodnitsky
• 

  Gene editing

  ‘Safer’ CRISPR: Base Editing Breaks Through in the Clinic as Beam, Verve Advance

  Beam Therapeutics and Verve Therapeutics have each built their lead candidates on a technique billed as a safer alternative to conventional CRISPR. Clinical results have so far been promising.

  May 5, 2025

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  9 min read

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  Shawna Williams
• 

  Policy

  FDA Rehires User Fee Negotiators After Mass Employee Layoffs: Reuters

  The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent staffing exodus.

  May 5, 2025

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  2 min read

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  Tristan Manalac
• 

  Gene therapy

  Vertex Abandons AAV as Gene Therapy Space Weathers Difficulties

  The cell and gene therapy space in recent months has hit several speedbumps, including layoffs, dropped drugs and discontinued partnerships.

  May 5, 2025

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  2 min read

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  Tristan Manalac
• 

  Layoffs

  BMS Axes 516 More Employees in New Jersey

  Bristol Myers Squibb has made significant cuts to its workforce since last year as part of a strategic reorganization aimed at saving $3.5 billion through 2027. The latest cuts in Lawrenceville, New Jersey, bring that area’s total number of disclosed cuts this year to 806.

  May 5, 2025

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  2 min read

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  Angela Gabriel
• Press Releases

  Aquestive Therapeutics to Participate in Citizens Life Sciences Conference

  May 5, 2025

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  3 min read
• Press Releases

  Foghorn Therapeutics to Participate in the Citizens Life Sciences Conference

  May 5, 2025

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  1 min read