BioSpace News Archive

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  Drug Development

  Ionis Touts Positive Topline Phase III Results for HAE Drug, Plans NDA

  The company said it’s preparing to file a New Drug Application with the FDA on the strength of late-stage study data for its investigational RNA-targeted donidalorsen in patients with hereditary angioedema.

  January 24, 2024

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  2 min read

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  Tyler Patchen
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  Drug Development

  Decentralized Clinical Trials Are the Future; Here’s How to Avoid Pitfalls

  While decentralized trials are expediting innovation and promoting diversity, challenges remain, including complex stakeholder ecosystems, skills gaps and regulation.

  January 24, 2024

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  4 min read

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  Chris Scheefer
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  Deals

  BioSpace Survey Reveals Continued Apprehension Around Job Market

  Most respondents expressed concerns about the economic environment, as competition for jobs jumped more than 130%.

  January 24, 2024

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  4 min read

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  Charlotte LoBuono
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  Drug Development

  Selecting a Compound for Drug Development – The Importance of Knowledge Management

  Drug discovery requires complex and multi-faceted decisions to justify billion-dollar investments that will take years to realize.

  January 24, 2024

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  1 min read

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  inPhronesis Knowledge Management Advisory Board
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  Policy

  Theratechnologies Gets FDA Rejection for Concentrated Formulation of Tesamorelin

  The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.

  January 24, 2024

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  2 min read

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  Tristan Manalac
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  Drug Development

  Lilly’s Investigational Gene Therapy Restores Hearing in First Treated Patient

  In a Phase I/II trial, an 11-year-old boy gradually regained hearing—eventually reaching normal range for some frequencies at 30 days—following treatment with Eli Lilly’s dual adeno-associated viral vector-delivered gene therapy.

  January 24, 2024

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  2 min read

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  Tristan Manalac
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  NIH Committee’s $70K Salary Recommendation for Postdocs Criticized as ‘Not Enough’

  The newly proposed salary increase for NIH-funded postdocs would not make the positions competitive with what the industry offers, experts said.

  January 24, 2024

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  4 min read

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  Aayushi Pratap
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  Policy

  J&J, Legend to Face Adcomm for Carvykti’s Push as Earlier Line MM Treatment

  An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.

  January 24, 2024

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  2 min read

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  Tristan Manalac
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  Job Trends

  Top 5 Biopharma Companies Hiring Engineers

  In the biopharma industry, engineers are pivotal drivers of innovation, helping to shape the landscape of healthcare discoveries.

  January 24, 2024

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  1 min read

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  BioSpace Editorial Staff
• 

  Policy

  Gilead’s Tecartus Gets Slight Reprieve on FDA List of CAR-T Boxed Warnings

  While the FDA considers a T cell malignancy risk to be applicable to all commercial CAR-T therapies, Gilead Sciences’ Tecartus has a revised warning that potential adverse events “may” occur.

  January 24, 2024

   · 

  2 min read

   · 

  Tyler Patchen