UniQure’s Path for Huntington’s Gene Therapy Clouded by Ethical Questions as Potential Phase 3 Looms
While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be ...
UniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA official.
Subjecting participants to invasive procedures without the prospect of therapeutic benefit is unjustifiable,” says the CEO of ...
A senior FDC official said the product is a “failed therapy” and confirmed that regulators have asked uniQure to run a new trial to prove the therapy actually helps Huntington’s patients. The ...
uniQure held a Type A meeting with the FDA at the end of January and, in a statement released today, said the agency "cannot agree that data from the Phase I/II studies, compared to an external ...
Add Yahoo as a preferred source to see more of our stories on Google. MRI of a brain with Huntington's Disease. (Zephyr/Science Source) Every week neurologist Victor Sung sees people with Huntington’s ...
Huntington’s disease (HD) is one of those rare conditions that affects not just the patient but the entire family—medically, emotionally and genetically. This inherited brain disorder causes gradual ...
Researchers have made an important Huntington's disease discovery. They have found that the protein mutated in patients with Huntington's disease doesn't repair DNA as intended, impacting the ability ...
ST. LOUIS — Scientists may have reached a breakthrough in the fight against Huntington’s disease, a rare and fatal inherited brain disorder with no cure. For the first time, a gene therapy has been ...
Researchers in the United Kingdom say they have successfully trialed what could become the world's first gene therapy for Huntington's disease – a fatal neurodegenerative disorder that is typically ...
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QURE jumps 20% – analysts upgrade stock on Huntington’s disease therapy update, retail eyes $150
UniQure’s AMT-130 is a gene therapy to reduce levels of the Huntingtin protein in the brain. ・The FDA recently said that data ...
By Michael Erman and Puyaan Singh March 5 (Reuters) - A senior FDA official called UniQure's experimental treatment for ...
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