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Pharming announces first patient enrolled in pediatric clinical trial of leniolisib

thaipr.net — Wed, 22 Feb 2023 08:15:14 +0700

The multinational Phase III study is evaluating leniolisib tablets in children aged 4 to 11 years with APDS, a rare primary immunodeficiency Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM)/(Nasdaq: PHAR) announces that the first patient has been enrolled in its Phase III clinical trial (NCT05438407) evaluating the investigational drug leniolisib, an oral, selective […]

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Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe

thaipr.net — Fri, 17 Feb 2023 08:28:14 +0700

EMA Marketing Authorisation Application for leniolisib changed to standard review timetable Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has decided to shift its assessment of the Marketing Authorisation Application (MAA) for leniolisib to a standard review timetable. […]

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Pharming announces positive interim analysis data from open-label extension study of leniolisib in presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition

thaipr.net — Fri, 16 Dec 2022 08:33:14 +0700

V. Koneti Rao, MD, shared new evidence of long-term safety and hematologic response in patients who received leniolisib to treat APDS, a rare primary immunodeficiency Interim analysis demonstrated leniolisib to be well tolerated and indicated the durability of the efficacy results seen in the Phase II/III randomized, controlled trial Pharming Group N.V. (“Pharming” or “the […]

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Pharming announces publication of data from Phase 3 Study of leniolisib in patients with APDS in ASH’s Blood

thaipr.net — Thu, 08 Dec 2022 08:00:00 +0700

Leniolisib was well tolerated and significant improvement over placebo was notable in the co-primary endpoints, reflecting a favorable impact on patients’ immune dysregulation and deficiency The peer-reviewed publication heightens international understanding of APDS, a rare and recently characterized immunodeficiency Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces today that the […]

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Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib

thaipr.net — Mon, 31 Oct 2022 08:05:00 +0700

Marketing authorisation in the European Economic Area anticipated in H1 2023 Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) announces today that its Marketing Authorisation Application (MAA) for leniolisib has been validated for scientific evaluation under an accelerated assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human […]

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Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib

thaipr.net — Wed, 12 Oct 2022 08:00:00 +0700

Application is based on randomized, controlled and long-term extension data for leniolisib as a treatment for APDS, a rare primary immunodeficiency This submission follows the grant of accelerated assessment allowing an expedited review for leniolisib from a standard 210 days to 150 days Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that it has […]

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Pharming Announces New ICD-10-CM Code for APDS, a Rare Primary Immunodeficiency

thaipr.net — Wed, 03 Aug 2022 08:50:16 +0700

Implemented by the Centers for Disease Control and Prevention, the diagnosis code will accurately identify US patients with APDS, supporting care and research efforts Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that a new diagnosis code for reporting cases of activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, […]

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Pharming Announces Positive Data from Phase II/III Leniolisib Trial Presented at Clinical Immunology Society 2022 Annual Meeting

thaipr.net — Mon, 04 Apr 2022 08:00:00 +0700

Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces new data from the pivotal Phase II/III trial of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a primary immunodeficiency. Principal Investigator V. Koneti Rao, M.D., a staff physician in the Primary Immune Deficiency Clinic at the National Institutes […]

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