Gain Therapeutics reports financial results for Second Quarter 2024 and provides corporate update. "...we eagerly await the full topline results from the MAD part of the study expected this month . . . [and] look forward to presenting our findings at medical conferences this fall and advancing GT-02287 into a Phase 1b study . . . in the fourth quarter of 2024" stated Interim CEO and current CFO Gene Mack. Read the full press release here: https://lnkd.in/g4sgh44S
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In this new Cell & Gene article, BioPhorum discusses how #cellandgenetherapy companies can use prior knowledge and platforms to leverage process characterization to reduce the testing and/or studies required during process validation for drug substance and drug product manufacturing processes. https://lnkd.in/e-6-6AZT #cellandgenetherapies #processdevelopment #biotech BioPhorum Advanced Therapy Medicinal Products
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In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
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In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
New Medicines, Novel Insights: Parexel introduces FDA expedited designation trends for advanced therapies
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In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
New Medicines, Novel Insights: Parexel introduces FDA expedited designation trends for advanced therapies
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In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
New Medicines, Novel Insights: Parexel introduces FDA expedited designation trends for advanced therapies
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In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
New Medicines, Novel Insights: Parexel introduces FDA expedited designation trends for advanced therapies
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In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
New Medicines, Novel Insights: Parexel introduces FDA expedited designation trends for advanced therapies
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Vice President (Global leader) Integrated Solutions Strategy, DEI Leader, Co-Lead of Global Disability Steering Committee, Professor (h.c.), Entrepreneur in Residence, GlobalScot, Speaker and Board member.
In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
New Medicines, Novel Insights: Parexel introduces FDA expedited designation trends for advanced therapies
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In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
New Medicines, Novel Insights: Parexel introduces FDA expedited designation trends for advanced therapies
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In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
New Medicines, Novel Insights: Parexel introduces FDA expedited designation trends for advanced therapies
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