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479,688 Results for "libella gene therapeutics".
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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
·
5 min read
·
Angela Gabriel
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
·
2 min read
·
Tristan Manalac
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
·
2 min read
·
Tristan Manalac
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
·
2 min read
·
Tristan Manalac
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
·
2 min read
·
Kate Goodwin
Gene therapy
Roche Inks Potential $1B Gene Therapy Deal With Dyno, Eyes Neurological Diseases
With an upfront payment of $50 million from Roche, the partnership will leverage Dyno Therapeutics’
in vivo
gene therapy delivery technology, which synthesizes virus capsids with better functionality and manufacturability.
October 24, 2024
·
2 min read
·
Tristan Manalac
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
·
2 min read
·
Tristan Manalac
Gene editing
Intellia’s CRISPR Gene Editor Shows Early Promise With Strong Biomarker Benefit in ATTR Amyloidosis
Analysts appear optimistic for Intellia’s gene editor nex-z, which showed a greater serum TTR reduction than Alnylam’s Amvuttra.
November 18, 2024
·
3 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
·
Annalee Armstrong
Regulatory
Sangamo’s Fabry Gene Therapy Could Hit Market 3 Years Earlier With FDA Accelerated Approval Pathway
The regulator agreed to allow Sangamo Therapeutics to use data to seek accelerated approval for its Fabry gene therapy candidate, eliminating the need for an additional registrational study and potentially shortening the time-to-market by three years.
October 23, 2024
·
2 min read
·
Tristan Manalac
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