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265,978 Results for "facio therapies".
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Pipeline
Neurogene Drops Batten Gene Therapy Program
After failing to receive the RMAT designation from the FDA for its early-stage Batten disease gene therapy, Neurogene tells investors that it’s evaluating options for the program.
November 19, 2024
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2 min read
·
Kate Goodwin
Neurodegenerative disease
UniQure Clears Path to Accelerated Approval for Huntington’s Gene Therapy
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified Huntington’s Disease Rating Scale, and neurofilament light chain levels to support the accelerated approval of its gene therapy AMT-130.
December 10, 2024
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2 min read
·
Tristan Manalac
Career Advice
The Right Fit: What BMS, Intellia Look for in Cell and Gene Therapy Talent
When hiring job candidates to work on cell and gene therapies, companies look for more than just technical skills. Talent acquisition executives from Bristol Myers Squibb and Intellia Therapeutics offer an inside look at what they want in an employee.
December 12, 2024
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5 min read
·
Angela Gabriel
Drug pricing
Bluebird, Vertex/CRISPR’s SCD Gene Therapies Get New CMS Payment Model
The payment scheme will tie gene therapy payments to improvements in health outcomes—and could potentially boost the uptake of these sickle cell disease treatments.
December 5, 2024
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2 min read
·
Tristan Manalac
Approvals
PTC Wins First FDA Nod for Direct-to-Brain Gene Therapy, Targets Ultrarare Disease
The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene therapy Kebilidi for AADC deficiency. It is the first approved gene therapy to be delivered directly to the brain.
November 14, 2024
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2 min read
·
Tristan Manalac
Gene therapy
Neurogene Details Gene Therapy Complication, Sending Shares Plummeting Again
Neurogene’s shares fell by 36% as the market opened Monday morning following news that a patient experienced systemic hyperinflammatory syndrome in a Phase I/II clinical trial of Rett syndrome gene therapy NGN-401.
November 18, 2024
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2 min read
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Annalee Armstrong
Job trends
Cell Therapy Biotechs Hunt for Autoimmune Expertise in Pivot From Oncology
In a tough fundraising space, cell therapy biotechs pursuing autoimmune indications review staffing to ensure the right expertise is in place to tackle the new disease area.
November 6, 2024
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6 min read
·
Annalee Armstrong
Duchenne muscular dystrophy
Regenxbio Gears Up to Challenge Sarepta in DMD as Gene Therapy Advances to Pivotal Studies
Regenxbio is pushing its Duchenne muscular dystrophy gene therapy into pivotal development, with a BLA planned for 2026—potentially posing a threat to Sarepta’s Elevidys.
November 19, 2024
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2 min read
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Tristan Manalac
Press Releases
ELMCRx Solutions Offers Cell & Gene Therapy Support Through Partnership with Emerging Therapy Solutions (ETS)
December 12, 2024
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3 min read
Press Releases
Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA® (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive Therapy
December 4, 2024
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11 min read
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