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PrecisionLife and NATA Announce R&D Partnership to Jointly Develop New Motor Neurone Disease / ALS Drug Programme
3/26/2024
The pioneering precision medicine company, PrecisionLife, and the MRC nucleic acid therapy research unit, NATA, today announce a collaboration to co-develop novel
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Health Canada Accepts for Review New Drug Submission for Tofersen for Treatment of Rare, Genetic Form of ALS
3/19/2024
Biogen Canada Inc. announced that Health Canada has accepted for review a New Drug Submission for tofersen for the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 gene.
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Voyager Therapeutics Announces Appointment of Toby Ferguson as Chief Medical Officer
3/13/2024
Voyager Therapeutics, Inc. today announced the appointment of Toby Ferguson, M.D., Ph.D., as Chief Medical Officer (CMO), effective March 25, 2024.
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Amid the limitations of current therapies for amyotrophic lateral sclerosis, a new GlobalData report points to novel disease-modifying drug approaches that could transform the space.
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Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP
2/23/2024
Biogen Inc. announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® for the treatment of adults with amyotrophic lateral sclerosis, associated with a mutation in the superoxide dismutase 1 gene.
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Coya Therapeutics to Present Novel Biomarker Survival Data in Large Cohort of ALS (Amyotrophic Lateral Sclerosis) Patients at Society of Neuroimmune Pharmacology Conference
2/22/2024
Coya Therapeutics, Inc. announces that Dr. Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory Board, will present data on its novel oxidative stress biomarker candidate from a large cohort of Amyotrophic Latera Sclerosis (ALS) patients at the upcoming Society of Neuroimmune Pharmacology Conference being held on March 10-13, 2024 in Charleston, SC.
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Biogen Reaps Rewards of Reata Buyout with EU Approval for Skyclarys in Friedreich’s Ataxia
2/13/2024
Following Biogen’s $7.3 billion acquisition of Reata Pharmaceuticals in July 2023, the drug on Monday was approved in the European Union for treating the rare genetic disorder that causes progressive damage to the nervous system. -
UPDATE - Gain Therapeutics’ GT-02287 Completely Restores Motor Function in Mouse Models of Parkinson’s Disease
2/6/2024
Gain Therapeutics, Inc. announces preclinical data demonstrating that its clinical-stage GCase regulator GT-02287 provided neuroprotection and restored motor function in Parkinson’s disease models following delayed administration.
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Ionis poised for continued momentum in 2024 with product launches and key advances in robust pipeline of investigational medicines for serious diseases
1/8/2024
Ionis Pharmaceuticals, Inc. announced highlights from the Company's 2023 achievements and previewed a number of important milestones expected in 2024.
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Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
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Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.”
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Red Biotechnology Market Size to Garner Around USD 618.64 Billion by 2032
11/16/2023
The global red biotechnology market size is predicted to garner around USD 618.64 billion by 2032 and is expanding at a CAGR of 5.41% from 2023 to 2032.
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Ionis reports third quarter 2023 financial results
11/2/2023
Ionis Pharmaceuticals, Inc., reported financial results for the third quarter of 2023.
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Opinion: The Potential of Neurofilament Light Chain as a Biomarker in Parkinson’s Disease
10/23/2023
While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that. -
Ionis shares significant business and pipeline progress at Innovation Day, highlighting strength of capabilities from research and technology through commercialization
10/4/2023
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) is holding an investor and analyst event, Ionis Innovation Day: Discovering, Developing and Delivering Transformational Medicines, in New York City today.
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After a groundbreaking year in the Alzheimer’s space, Parkinson’s disease researchers express renewed hope based on a greater biological understanding of neurodegeneration.
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The company’s experimental drug for amyotrophic lateral sclerosis reduced the risk of death by 49% compared to the largest U.S. database of previous ALS therapy trials.
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The FDA’s briefing documents found that BrainStorm's BLA submission for its investigational cell therapy for ALS did not demonstrate evidence of effectiveness and that the manufacturing data was “grossly deficient.”
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The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.
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Gain Therapeutics Presents New Preclinical Data Demonstrating a Reduction of Plasma Neurodegeneration Biomarker NfL after Administration of its Drug Candidate GT-02287 in GBA1 Parkinson’s Disease Model
8/28/2023
Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”) today announced preclinical data demonstrating the Company’s lead drug candidate GT-02287 significantly decreased Parkinson’s disease (PD)-associated pathology and improved motor dysfunction in two different preclinical models of Parkinson’s disease.