Italfarmaco

13 articles about Italfarmaco

• Italfarmaco Group Announces New PDUFA Date for Givinostat DMD NDA

  11/29/2023

  Italfarmaco Group announced that the U.S. Food and Drug Administration has extended the review process of the New Drug Application for Givinostat, the company’s proprietary histone deacetylase inhibitor for the treatment of Duchenne Muscular Dystrophy.

• Italfarmaco Group Receives EMA Validation of Marketing Authorization Application for Givinostat in Duchenne Muscular Dystrophy

  9/5/2023

  Italfarmaco Group announced that its Marketing Authorization Application for Givinostat as a potential treatment for Duchenne Muscular Dystrophy has been submitted to the European Medicine Agency and that the EMA has started its regulatory review process.

• Italfarmaco Group Completes FDA Submission of New Drug Application for Givinostat in Duchenne Muscular Dystrophy and Receives Priority Review

  6/29/2023

  Italfarmaco Group announced that the U.S. Food and Drug Administration has completed its filing review and accepted the company’s New Drug Application for Givinostat.

• Italfarmaco Acquires 100% of Lacer, a Spanish Pharmaceutical Company That Is a Leader in Health Care and Personal Hygiene

  7/27/2022

  Italfarmaco, an Italian multinational company in the chemical-pharmaceutical sector, has acquired 100% of Lacer Pharmaceuticals, one of the leading companies in Spain in the area of health and personal hygiene.

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  Global Roundup: Italfarmaco Makes Progress against DMD, Clover Scores on Omicron

  6/30/2022

  Italfarmaco is making headway against DMD as it announced positive results from a Phase III study, Clover's homologous booster against Omicron increases antibodies, and much more.

• Italfarmaco Group Announces Positive Topline Data from Phase 3 Trial Showing Beneficial Effect of Givinostat in Patients with Duchenne Muscular Dystrophy

  6/26/2022

  Italfarmaco Group announced positive topline data from its completed Phase 3 EPIDYS trial with Givinostat, the company’s proprietary histone deacetylase inhibitor, in boys with Duchenne Muscular Dystrophy.

• Italfarmaco Announces Topline Data from Phase 2 Trial with Givinostat in Patients with Becker Muscular Dystrophy

  6/26/2021

  Italfarmaco Group announced topline data from its proof-of-concept Phase 2 trial with Givinostat, the company’s proprietary histone deacetylase inhibitor, in 51 adult males with Becker Muscular Dystrophy.

• Italfarmaco Group Enters Into an Agreement with Luye Pharma to Commercialize Alzheimer’s Disease Treatment Rivastigmine Multi-Day Transdermal Patch in Four European Countries

  3/16/2021

  Italfarmaco Group adds innovative Alzheimer’s disease therapy to its neurology-based product portfolio

• Italfarmaco Provides Update on Ongoing Clinical Programs with Givinostat in Oral Presentation at XVIII International Conference on Duchenne and Becker Muscular Dystrophy

  2/22/2021

  Analyses of long-term study with Givinostat in Duchenne Muscular Dystrophy boys continue to show delayed disease progression

• Italfarmaco Receives FDA Rare Pediatric Disease Designation for Givinostat in Duchenne Muscular Dystrophy, Announces Completed Enrollment in EPIDYS Phase 3 Trial

  10/9/2020

  The Italfarmaco Group provided an update on the development of Givinostat, its proprietary histone deacetylase inhibitor, in boys with Duchenne Muscular Dystrophy.

• Italfarmaco Provides Update on Advanced-Stage Clinical Development Program with Givinostat in Duchenne Muscular Dystrophy

  4/27/2020

  The Italfarmaco Group provided an update on the clinical development program of Givinostat, its proprietary histone deacetylase inhibitor, in Duchenne Muscular Dystrophy.

• Italfarmaco Enters Binding Term Sheet Agreement With Neupharma for an Exclusive Option to Develop and Commercialize Inhaled Teicoplanin

  8/1/2019

  Italfarmaco Group announced that Italfarmaco SpA, a member company, has entered into a binding term sheet agreement with Neupharma for an exclusive option to develop and commercialize inhaled teicoplanin.

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  Italfarmaco R&D Head Shares Strong Clinical Data at ASH

  12/21/2017

  Italfarmaco has its eyes set on bringing a new treatment that targets the underlying mechanism of the blood disorder Polycythemia Vera.