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Sangamo, Pfizer Announce First Patient Receives SB-525 Treatment in Clinical Trial
August 28, 2017Sangamo Therapeutics and Pfizer announced the first patient received treatment in the Phase 1/2 clinical trial (Alta trial) evaluating SB-525, an investigational gene therapy for patients with Hemophilia A, a rare genetic blood disorder. -
Roche gets priority review for hyped hemophilia A prospect
August 25, 2017The FDA has granted priority review status to Roche’s hemophilia A candidate emicizumab, setting up the Swiss drugmaker to learn its fate by Feb. 23. Roche enters the review process armed with impressive efficacy data that risks being undermined by safety -
FDA Grants Priority Review to Genentech’s Emicizumab for Hemophilia A with Inhibitors
Genentech announced the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adoles
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Shire submits IND application to FDA for gene therapy candidate SHP654 for treatment of hemophilia A
July 13, 2017SHP654 aims to deliver sustained protection against bleeds for patients with hemophilia A. -
Genentech Announces Positive Interim Results for Emicizumab in Phase III Study of Children with Hemo
April 18, 2017Genentech has announced interim results from the Phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with hemophilia A and inhibitors to factor VIII.
Pharma Sources Insight January 2025
