Pharming Group N.V.
P.O. Box 451
AL Leiden
2300
Tel: 31-0-71-524-7400
Fax: +31-0-71-521-6507
Website: http://www.pharming.com/
Email: pharming@pharming.com
297 articles with Pharming Group N.V.
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Pharming announces first patient enrolled in pediatric clinical trial of leniolisib
2/21/2023
Pharming Group N.V. announces that the first patient has been enrolled in its Phase III clinical trial evaluating the investigational drug leniolisib, an oral, selective phosphoinositide 3-kinase delta inhibitor, in children with activated phosphoinositide 3-kinase delta syndrome.
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Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe
2/16/2023
Pharming Group N.V. announces that the European Medicines Agency's Committee for Human Medicinal Products has decided to shift its assessment of the Marketing Authorisation Application 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
12/15/2022
Pharming Group N.V. announces data, including new evidence, from an interim analysis of its open-label extension study evaluating the investigational drug leniolisib, an oral, selective phosphoinositide 3-kinase delta inhibitor, to treat adult and adolescent patients with activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency.
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Pharming announces publication of data from Phase 3 Study of leniolisib in patients with APDS in ASH's Blood
12/7/2022
Pharming Group N.V. announces that the positive results of a Phase 3 clinical trial of the investigational drug leniolisib, an oral, selective phosphoinositide 3-kinase delta inhibitor, in adult and adolescent patients with activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency, have been published in Blood,1 the peer-reviewed international medical journal of the American Society of Hematology.
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Pharming Group announces presentation of new leniolisib data at 2022 ASH Annual Meeting
11/23/2022
Pharming Group N.V. announces that new clinical data for leniolisib will be presented by V. Koneti Rao, MD, FRCPA, staff physician in the Primary Immune Deficiency Clinic at the National Institute of Health in Bethesda, Maryland, at the 64th American Society of Hematology Annual Meeting and Exposition, in New Orleans, Louisiana taking place from Saturday, December 10 through Tuesday, December 13, 2022.
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Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib
10/28/2022
Pharming Group N.V. announces that its Marketing Authorisation Application for leniolisib has been validated for scientific evaluation under an accelerated assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use.
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Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib
10/11/2022
Pharming Group N.V. announces that it has submitted a Marketing Authorisation Application to the European Medicines Agency for leniolisib, an oral, selective phosphoinositide 3-kinase delta inhibitor, as a treatment for activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency, in adults and adolescents 12 years or older.
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The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
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Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib
9/28/2022
Pharming Group N.V. announces that the US Food and Drug Administration has accepted for priority review its New Drug Application for leniolisib, an oral, selective phosphoinositide 3-kinase delta inhibitor, to treat the rare primary immunodeficiency activated phosphoinositide 3-kinase delta syndrome in adults and adolescents 12 years of age and older in the US.
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CEO of Pharming to present at H.C. Wainwright 24th Annual Global Investment Conference
9/7/2022
Pharming Group N.V. announces that its Chief Executive Officer, Sijmen de Vries, will present at the H.C. Wainwright 24th Annual Global Investment Conference, a hybrid meeting based in New York, at the Lotte Palace Hotel, September 12-14, 2022.
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Pharming Announces New ICD-10-CM Code for APDS, a Rare Primary Immunodeficiency
8/2/2022
Pharming Group N.V. announces that a new diagnosis code for reporting cases of activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency, will be added to the International Classification of Diseases, 10th Revision, Clinical Modification by the US Centers for Disease Control and Prevention.
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Pharming Group Receives Accelerated Assessment in Europe for leniolisib for the Treatment of Rare Immunodeficiency, APDS
8/1/2022
Pharming Group N.V. announces that the European Medicines Agency's Committee for Medicinal Products for Human Use has granted an accelerated assessment for the Marketing Authorisation Application for leniolisib.
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Editas Medicine snagged Rare Pediatric Disease designation for its experimental beta thalassemia gene therapy, while VBL received Fast Track designation for an ofra-vec combination in ovarian cancer.
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Pharming receives agreement of Paediatric Investigation Plan and Promising Innovative Medicine designation for leniolisib from UK MHRA
4/26/2022
Pharming Group N.V. announces that it has received a positive decision from the UK's Medicines and Healthcare Products Regulatory Agency on a Paediatric Investigation Plan submission for leniolisib, an oral, selective phosphoinositide 3-kinase delta inhibitor, for the treatment of activated phosphoinositide 3-kinase delta syndrome in patients from 1 year of age to less than 18 years of age.
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Pharming Announces Positive Data from Phase II/III Leniolisib Trial Presented at Clinical Immunology Society 2022 Annual Meeting
4/1/2022
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.
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Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
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Orchard Therapeutics and Pharming Group Announce Collaboration to Develop and Commercialize ex vivo autologous HSC Gene Therapy for Hereditary Angioedema
7/1/2021
Orchard Therapeutics announced a strategic collaboration to research, develop, manufacture and commercialize OTL-105, a newly disclosed investigational ex vivo autologous hematopoietic stem cell gene therapy for the treatment of hereditary angioedema, a life-threatening rare disorder that causes recurring swelling attacks in the face, throat, extremities and abdomen.
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Clinical Catch-Up: August 10-14
8/17/2020
It was a very busy week for clinical trial updates. Here’s a look. -
BioSpace Global Roundup, Aug. 13
8/13/2020
Biopharma and life sciences companies from across the globe provide updates on their business and pipelines. -
Pharming CFO to step down
3/11/2020
Pharming Group N.V. announced that its Chief Financial Officer, Robin Wright, has decided not to put himself up for re-election as a member of the Board of Management and thus as Chief Financial Officer at the upcoming General Meeting of Shareholders on 20 May 2020 and that, as result of this decision, his term with the Company will end as at that date..