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261,750 Results for "insys therapeutics".
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Drug Development
Our Mission at Voyager Therapeutics: Define the Future of Neurogenetic Medicines
We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system
May 8, 2024
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2 min read
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Voyager Therapeutics, Inc.
Regulatory
FDA Warns Applied Therapeutics of ‘Objectionable Conditions’ in Govorestat Study
The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.
December 4, 2024
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2 min read
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Tristan Manalac
Press Releases
NeuroEM Therapeutics(R) Accepted into StartUp Health’s Alzheimer’s Moonshot Community(TM)
September 19, 2024
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4 min read
Press Releases
Cara Therapeutics and Tvardi Therapeutics Announce Entry into Merger Agreement
December 18, 2024
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16 min read
Complete response letters
Applied Therapeutics Crashes After FDA Rejection of Rare Disease Drug
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.
December 2, 2024
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3 min read
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Tristan Manalac
Layoffs
Spero Therapeutics to Lay Off 39% of Employees
Following disappointing results for an antibiotic candidate whose development program is now being suspended, Spero Therapeutics is looking to extend its cash runway while it focuses on other assets in its pipeline.
October 30, 2024
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1 min read
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Angela Gabriel
Layoffs
Viracta Therapeutics Cuts 42% of Staff as Part of Resource Reprioritization
Following two layoffs in less than three months, Viracta Therapeutics may have around 18 employees left to advance its efforts to bring lead product candidate nana-val to market.
November 7, 2024
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2 min read
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Angela Gabriel
Press Releases
Outlook Therapeutics® Announces Executive Leadership Transition
December 3, 2024
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5 min read
Layoffs
Relay Therapeutics to Lay Off 10% of Workforce
Relay Therapeutics is cutting its workforce to help streamline its research organization as it looks to complete its first large-scale, pivotal clinical trial.
October 4, 2024
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1 min read
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Angela Gabriel
Mergers & acquisitions
Novartis Buys Kate Therapeutics, Eyeing $55B CGT Market Opportunity by 2030
Novartis’ up to $1.1 billion acquisition of gene therapy specialist Kate Therapeutics fits with the pharma’s plan to expand its new modality pipeline to ensure long-term business sustainability.
November 21, 2024
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2 min read
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Tristan Manalac
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