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Assess Risks of Gene Therapy in Follow-Up Study: FDA Panel

A panel of advisers to the regulator said on Tuesday Vertex Pharmaceuticals and CRISPR Therapeutics could assess potential safety risks of their sickle cell disease gene therapy after approval.

Salim syedKrishna chandra eluriSriparna royScot wolfeDrug administrationUmass chan medical schoolVertex pharmaceuticalsTuesday vertex pharmaceuticalsChan medicalSickle cell diseaseIckle cell anemia sickle anaemiaGenomics genomic medicineBiologic therapyUs food and drug administrationNited states food and drug administrationGene therapy

Can Better Sleep Improve Blood-Sugar Levels in Type 1 Diabetics?

A researcher has been awarded a $3.5 million grant to improve sleep health and glucose management in young adults with type 1 diabetes.

United statesBetul hatipogluJamie woodJulia blanchetteSybil crawfordMichael perlisAgnes stahlin baunStephanie griggsRonald hickman jrKingman strohlUniversity hospitalsUmass chan medical schoolDiabetes center at university hospitalsPerelman school of medicineSchool of medicineCase western reserve school of medicine

FDA moves closer to sickle cell cure that uses gene editing

FDA moves closer to sickle cell cure that uses gene editing
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United statesStephan gruppLisa leeBiree andemariamScot wolfeJoseph wuInstitute for clinicalEngland sickle cell instituteDrug administrationUmass chan medical schoolVertex pharmaceuticalsVirginia polytechnic instituteUniversity of connecticutCenters for diseaseStanford cardiovascular instituteDisease control

FDA panel says Vertex/CRISPR to assess safety risks of gene therapy in follow-up study

If the therapy is approved, Vertex has proposed a 15-year follow up of patients to evaluate the safety outcomes of the therapy. A vaso-occlusive crisis occurs when sickled red blood cells block blood flow to the point that tissues become deprived of oxygen and causes pain. The panel members said the 15-year follow up will help generate data from real-time monitoring of the therapy, which uses the new gene editing CRISPR technology.

Salim syedKrishna chandra eluriSriparna royScot wolfeVertex pharmaceuticalsDrug administrationUmass chan medical schoolTuesday vertex pharmaceuticalsChan medicalGene therapyVertex pharmaceuticalsCrispr therapeuticsCrispr technologySickle cell diseaseRed blood cellsGene editing

Vertex, Crispr Get FDA Panel Support for Sickle-Cell Treatment

Vertex, Crispr Get FDA Panel Support for Sickle-Cell Treatment
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United statesJoseph wuScot wolfeStanford universityVertex pharmaceuticals incDepartment of molecularDrug administrationUmass chan medical schoolVertex pharmaceuticalsCrispr therapeuticsChan medical