The Earth Times

Gene Therapy Meets Regulatory Reality: The FDA–uniQure Clash Over a Promising Huntington’s Treatment

The FDA’s dispute with biotech firm uniQure over Huntington’s gene therapy highlights growing tensions between innovation, ...

FDA push for fake Huntington’s brain surgery trial spurs ethical concerns

Subjecting participants to invasive procedures without the prospect of therapeutic benefit is unjustifiable,” says the CEO of ...

FDA calls for fresh study of uniQure's Huntington's gene therapy, shares slide

By Puyaan Singh and Christy Santhosh March 2 (Reuters) - UniQure said the U.S. drug regulator called for a new study to ...
Technology Networks

Fetal Therapy Could Offer a Lifeline for Children With Genetic Disorders

Thanks to advances in imaging and diagnostic technologies, clinicians can now detect many genetic disorders in the womb, ...
Fierce Biotech

UPDATED: Senior FDA official refutes uniQure's claims amid controversy over Huntington's gene therapy

In a strikingly blunt briefing, a senior FDA official accused uniQure of pushing “distorted” data to mask a “failed” therapy ...
BioSpace

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 ...

Abeona Therapeutics® Provides Business Update Highlighting Building Momentum in ZEVASKYN® Commercial Launch

Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced an update on the building momentum in the Company’s launch of FDA-approved ZEVASKYN (prademagene zamikeracel), a first-of-its-kind, autologous ...

FDA defends its demand for new trial for rare brain disease therapy

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 ...

QuTEM Collaborates with Boston University to Bring Advanced Quality Control Analysis to American Gene Therapy Developers

QuTEM and Boston University collaborate to provide localized, high-speed AAV analysis for North American gene therapy ...
The Independent

Breakthrough sickle cell gene therapy a distant hope in Africa

Advocates stress that while gene therapy is causing a buzz in wealthy countries, African governments must prioritise prevention, screening and accessible treatment NEWS ANALYSIS | JOHN MUSENZE | As ...
Blockonomi

FDA Rejects uniQure’s AMT-130 Gene Therapy Approval Plan, Sending QURE Stock Plunging

Qure stock plunged 45% after FDA rejected AMT-130 approval pathway, requiring new randomized trial for Huntington's disease ...

$14+ Bn Cell Therapy Manufacturing Market Trends and Forecasts, 2035 - Researchers are Exploring Over 1,000 Cell and Gene Therapy Candidates Targeting a Wide Range of Disease ...

The cell therapy manufacturing market offers significant opportunities driven by technological advancements, increasing clinical trials, and growing regulatory approvals. Key growth catalysts include ...