BioSpace News Archive

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  Business

  A Conversation with Peter Marks: Insights into GenScript Biotech Forum 2025

  In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies.

  January 16, 2025

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  1 min read

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  Lori Ellis
• 

  Immunology and inflammation

  Lilly’s I&I Push Gains Momentum With Omvoh Expansion

  Omvoh’s label expansion is important progress for Eli Lilly as it works to diversify its portfolio beyond obesity, according to analysts from BMO Capital Markets.

  January 16, 2025

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  2 min read

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  Tristan Manalac
• 

  China

  The Rise of China Innovation in the Time of Trump

  With incoming president Donald Trump threatening a trade war with China, experts told BioSpace that the new administration will likely understand why medicines should be treated differently.

  January 16, 2025

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  4 min read

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  Annalee Armstrong
• 

  Complete response letters

  Manufacturing Issues Result in FDA Rejection of Atara’s Cell Therapy

  Atara Therapeutics’ Ebvallo, already marketed in Europe for a transplant-related blood cancer, will not hit the U.S. market just yet, forcing the company to “significantly reduce expenses.”

  January 16, 2025

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  1 min read

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  Dan Samorodnitsky
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  Legal

  HHS Says Vertex is ‘Grasping at Straws’ With Casgevy Fertility Suit

  Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes.

  January 16, 2025

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  2 min read

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  Tristan Manalac
• 

  Pipeline

  BioNTech Strives to Become Commercial ‘Powerhouse’ While Maintaining Humility

  Annemarie Hanekamp has overseen some of the most transformative changes in oncology over her years in Big Pharma. Now, she will oversee BioNTech’s transition from a COVID-19 vaccine maker to an “end-to-end organizational oncology powerhouse.”

  January 16, 2025

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  4 min read

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  Annalee Armstrong
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  Regulatory

  After Letter to Commissioner, FDA Finally Gives Vanda Reason for Rejection, Chance for Hearing

  After a series of strongly worded letters—one of which was addressed directly to Commissioner Robert Califf—the FDA has publicly laid out its reasoning for rejecting Vanda Pharmaceuticals’ gastroparesis drug candidate tradipitant.

  January 16, 2025

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  2 min read

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  Tristan Manalac
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  Pipeline

  JPM25 Day 3: AbbVie, Gilead, GSK and Dyne

  AbbVie and Gilead are going back to their roots and leaning on their established areas of expertise to set themselves up for sustainable success in 2025.

  January 16, 2025

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  3 min read

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  Tristan Manalac
• Press Releases

  Biomerica Reports Second Quarter Fiscal 2025 Financial Results

  January 16, 2025

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  6 min read
• Press Releases

  Windtree Strengthens Global Intellectual Property Portfolio with New Japanese Patent For the Company’s Oncology Pipeline

  January 16, 2025

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  6 min read