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Pictured: Boy in a wheelchair looking out the window

Italfarmaco Touts Positive Results in Phase III DMD Trial Ahead of PDUFA

In advance of a March 21 PDUFA date, Italfarmaco on Tuesday reported that its drug candidate givinostat met the primary endpoint for treating Duchenne muscular dystrophy.

March 20, 2024

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2 min read

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Tyler Patchen

Policy

Italfarmaco Receives FDA Approval for Duvyzat™ (givinostat) in Duchenne Muscular Dystrophy

Italfarmaco S.p.A. announced that the U.S. Food and Drug Administration has approved Duvyzat™, a novel histone deacetylase inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy, a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood.

March 21, 2024

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9 min read

Drug Development

Results from Italfarmaco Pivotal Phase 3 EPIDYS Study of Givinostat in Duchenne Muscular Dystrophy (DMD) Published in The Lancet Neurology

Italfarmaco S.p.A. announced today that the full results from the Company’s pivotal phase 3 EPIDYS clinical trial with givinostat in ambulant boys 6 years of age and older with Duchenne muscular dystrophy (DMD) have been published in The Lancet Neurology.

March 19, 2024

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7 min read

Italfarmaco Group Announces New PDUFA Date for Givinostat DMD NDA

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.

November 29, 2023

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2 min read

Nerviano Medical Sciences and Italfarmaco Announce Licensing of Linker-Payload Technology to Develop and Commercialize a Novel Peptide-Drug Conjugate

Nerviano Medical Sciences S.r.l., a clinical-stage biotechnology company member of NMS group, announced the signing of a license agreement with Italfarmaco S.p.A., a specialty pharmaceutical company, to develop and commercialize a novel peptide-drug conjugate.

December 14, 2023

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5 min read

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

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.

September 5, 2023

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4 min read

Policy

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

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.

June 29, 2023

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4 min read

Deals

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

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.

July 27, 2022

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4 min read

Drug Development

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

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.

June 29, 2022

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5 min read

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Alex Keown

Drug Development

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

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.

June 25, 2022

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7 min read