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Latest From bluebird bio
Gene Therapy Q1 Roundup: The Struggle Is Real
Vertex and bluebird compete for sickle cell patients, BioMarin talks about divesting Roctavian, and Sarepta warned that sales of Elevidys will plateau with a narrow label.
Accelerated Approval: Withdrawing Gene Therapies Could Be Easier Than Small Molecules
The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.
Pfizer Matches Beqvez Price To Hemgenix In Hemophilia B, Plans Warranty Program
The drug maker said the program would allow for continued reimbursement when patients change insurance plans. A Sangamo-partnered gene therapy for hemophilia A is also in the works.
Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List
There are pending requests to add 13 candidates to the tropical diseases that qualify for a priority review voucher, according to a Pink Sheet analysis, as FDA Commissioner Robert Califf faces congressional pressure on the years since the list's last update.
Company Information
- Industry
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Pharmaceuticals
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Drug Delivery
- Macromolecule
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Drug Delivery
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Biotechnology
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
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- Genetix Pharmaceuticals
- Precision Genome Engineering, Inc. (Pregenen)
- Oncology Newco
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