GenSight Biologics
66 articles with GenSight Biologics
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Diamond Pharma Services Supports GenSight Biologics in Submitting Its First Marketing Authorisation Application, for Ocular Gene Therapy LUMEVOQ
10/5/2020
Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ
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GenSight Biologics Submits EU Marketing Authorisation Application for LUMEVOQ® Gene Therapy to Treat Vision Loss Due to Leber Hereditary Optic Neuropathy (LHON)
9/15/2020
GenSight Biologics announced that it has submitted the Marketing Authorisation Application for its lead product LUMEVOQ® to the European Medicines Agency, seeking approval for the treatment of patients with vision loss due to Leber Hereditary Optic Neuropathy caused by mutation in the ND4 mitochondrial gene.
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BioSpace Global Roundup, July 9
7/9/2020
Biopharma and life sciences companies from across the globe provide updates on their pipelines and businesses. -
GenSight Biologics Reports Sustained Efficacy and Safety Among LHON Patients Three Years After LUMEVOQ® Treatment
7/6/2020
GenSight Biologics, a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, reported that Leber Hereditary Optical Neuropathy subjects treated with LUMEVOQ® experienced sustained efficacy and safety three years after a single injection with the gene therapy.
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Clinical Catch-Up: April 13-17
4/20/2020
There’s plenty of news related to clinical trials related to COVID-19, but it does seem to be drowning out non-COVID-19-related clinical trials. Here’s a look. -
BioSpace Global Roundup, April 16
4/16/2020
Global pharma and life sciences companies provide updates on their business operations and pipelines. -
GenSight Biologics on Track to Submit LUMEVOQ® for European Approval in September 2020 Following Pre-Submission Meeting with EMA
4/15/2020
GenSight Biologics, a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announces the completion of the pre-submission meeting with the European Medicines Agency for the Company’s lead product LUMEVOQ®.
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GenSight Biologics Announces Presentation of Bilateral Visual Recovery From GS010 (LUMEVOQ™) Phase III Trials at the 46th Annual Meeting of NANOS
3/3/2020
GenSight Biologics announced that the bilateral visual recovery observed with GS010 in the REVERSE and RESCUE Phase III trials will be presented and discussed at the 46th Annual Meeting of the North American Neuro-Ophthalmology Society - Amelia Island, Florida - March 7-12, 2020.
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Clinical Catch-Up: December 9-13
12/16/2019
It was a particularly busy week in clinical trial news, largely because of the American Society of Hematology Annual Meeting. Here’s a look. -
GenSight Biologics reports findings from REALITY study and REVERSE-RESCUE analysis highlighting positive benefits from LUMEVOQ™ (GS010) compared to LHON natural history
12/11/2019
GenSight Biologics reported results from the REALITY registry study and an analysis of REVERSE and RESCUE Phase III data, which further highlight the poor prognosis for patients with loss of vision due to Leber Hereditary Optic Neuropathy associated with the ND4 mutation.
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The Quinze-Vingts Hospital and GenSight Biologics Announce a First Temporary Authorization for Use (ATU) for LUMEVOQ™ (GS010) in France
12/9/2019
The National Eye Hospital of the Quinze-Vingts in Paris and GenSight Biologics announced that the French Competent Authority, the National Drug Safety Agency, granted a named patient Temporary Authorization for Use for LUMEVOQ™ to the CHNO of the Quinze-Vingts.
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The Quinze-Vingts Hospital and GenSight Biologics announce a first Temporary Authorization for Use (ATU) for LUMEVOQTM (GS010) in France
12/9/2019
The National Eye Hospital of the Quinze- Vingts in Paris and GenSight Biologics announced that the French Competent Authority, the National Drug Safety Agency, granted a named patient Temporary Authorization for Use for LUMEVOQTM to the CHNO of the Quinze-Vingts.
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BioSpace Global Roundup, Oct. 10
10/10/2019
Companies from across the globe provide updates on their business and pipelines. -
GenSight Biologics Reports Evidence of GS010 DNA Transfer to Contralateral Eye of Primates Unilaterally Injected With GS010 Gene Therapy
10/9/2019
First study to find direct evidence that therapeutic gene is transferred from the injected eye to the uninjected contralateral eye of primates
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GenSight Biologics Appoints Magali Taiel as Chief Medical Officer
10/8/2019
GenSight Biologics announced the appointment of Magali Taiel, MD, as Chief Medical Officer, effective immediately.
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Clinical Catch-Up: September 23-27
9/30/2019
It was a moderately busy week for clinical trial news. Here’s a look. -
BioSpace Global Roundup, Sept. 26
9/26/2019
Companies from across the globe share updates on their business and pipelines. -
RESCUE and REVERSE are two separate but parallel Phase III trials evaluating the efficacy of a single intravitreal injection of GS0101 in patients with LHON from the G11778A mutation in the mitochondrial ND4 gene.
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GenSight Biologics Reports Sustained Efficacy and Safety at 96 Weeks in RESCUE Phase III Clinical Trial of GS010 for the Treatment of Leber Hereditary Optic Neuropathy (LHON)
9/23/2019
GenSight Biologics, a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported the first set of results from Week 96 of the RESCUE Phase III clinical trial.
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GenSight Biologics completes enrollment of GS010 REFLECT Phase III trial in the treatment of Leber Hereditary Optic Neuropathy ahead of schedule
7/11/2019
GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that enrollment in REFLECT, a Phase III clinical trial of GS010 for the treatment of Leber Hereditary Optic Neuropathy (LHON)