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Alaric DeArment

Reporter

Alaric has been covering the biopharma industry and health care for more than 14 years. His areas of focus include clinical trials, drug development in hematology-oncology, cell and gene therapy and the industry's growing use of artificial intelligence and machine learning. He holds a bachelor's degree in journalism from Ball State University and previously lived in China for three years.

Latest From Alaric DeArment

Y-mAbs Shifts Focus To Approved Drug, Pipeline After Omburtamab CRL

The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.

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Ferring Makes Important Milestone For Microbiome With Rebyota Approval

The microbiome therapy won approval for preventing recurrence of Clostridioides difficile infections, but an analyst said the future could be in more targeted approaches.

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Nimbus Nips At BMS’s Heels With Psoriasis Results For TYK2 Inhibitor

Without disclosing data, Nimbus announced positive Phase IIb results for NDI-034858 in psoriasis. The company plans to initiate a Phase III trial next year.

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US FDA Guidance Aims To Tackle Challenges In Multi-Endpoint Trials

Final guidance targets the ‘multiplicity problem.’ At about half the length of the 2017 draft, the final removes some sections, truncates other and drops several examples.

Clinical Trials Guidance Documents

Roche Withdraws Tecentriq’s Frontline Bladder Cancer Indication, Ceding Market To Keytruda

The move marks the second time since last year that Roche has withdrawn a urothelial carcinoma indication after its confirmatory trial failed to show an overall survival benefit.

Cancer ImmunoOncology

Spectrum Sees Potential Path For Poziotinib In NSCLC Despite Expected CRL

The CRL follows a negative FDA advisory committee vote in September. The company will lay off three-quarters of its R&D force, but sees potential to partner or sell the asset.

Complete Response Letters Business Strategies
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