Drug Discovery World
MAY 29, 2024
Marc Hummersone, Senior Director of Research and Development (R&D) at Astrea Bioseparations, shares insight on the challenges and opportunities in cell and gene therapy (CGT) with DDW’s Megan Thomas. His PhD and Post-Doctoral experience were focused on the total synthesis of complex natural products at University College, London.
XTalks
JUNE 30, 2023
It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. Hemophilia A is a rare genetic bleeding disorder that is caused by a mutation in the gene that encodes the key blood clotting protein factor VIII (FVIII).
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Drug Discovery World
NOVEMBER 13, 2023
She speaks with Megan Thomas about the future for Janssen’s investigational medicine nipocalimab and antibody therapeutics at large. This is a fully human monoclonal antibody (mAb) which selectively binds to the FcRn receptor with high-affinity and blocks it, thus leading to a decrease in IgG autoantibodies.
FDA Law Blog
DECEMBER 7, 2022
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
pharmaphorum
SEPTEMBER 13, 2021
AbbVie has expanded its ophthalmology pipeline via a licensing deal with Regenxbio, paying $370 million upfront to get its hands on a gene therapy for wet age-related macular degeneration (AMD) and other eye diseases. The post AbbVie spies potential in Regenxbio eye disease gene therapy appeared first on.
Drug Discovery World
APRIL 3, 2023
DS: What motivated you and Dr David Bunka, CTO, to create Aptamer and did you imagine you would one day be operating on such a global scale? AT : We initially met at the University of Leeds, where David was a post-doctoral researcher studying aptamers, and I was completing my PhD. What advantages do they offer over antibodies?
FDA Law Blog
MARCH 13, 2023
This meeting will host a panel of rare disease patients, caregivers, and advocates to have a focused discussion on the emerging field of gene therapy (regulated at the FDA by OTP). At least some (if not all) of the panelists will have had experience participating in gene therapy trials. One family’s daughter was the first U.S.
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