European Medicines Agency (EMA)
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom
Tel: 44-0-20-7523-7600
Website: http://www.ema.europa.eu/ema/
Email: info@ema.europa.eu
687 articles with European Medicines Agency (EMA)
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Xenikos Announces T-Guard® Phase 3 Clinical Update and Outlines 2021-2022 Corporate Objectives
7/19/2021
Xenikos B.V. announced that it has reached agreement with the US Food and Drug Administration and the European Medicines Agency on the design of its pivotal randomized Phase 3 clinical study to evaluate T-Guard® versus ruxolitinib for the treatment of patients with Grade III or IV steroid-refractory acute graft-versus-host disease following allogeneic hematopoietic stem cell transplant.
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The randomized, multi-center study called CheckMate -651 evaluates Opdivo 3 mg/kg every two weeks in combination with Yervoy 1mg/kg every six weeks.
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If approved, lenacapavir would be offered to HIV patients who have been heavily treated for the disease and have multi-drug-resistant HIV.
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Agios Submits Marketing Authorisation Application to European Medicines Agency for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency
6/28/2021
Agios Pharmaceuticals, Inc., a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, announced that it has submitted a Marketing Authorisation Application for mitapivat to the European Medicines Agency for the treatment of adults with pyruvate kinase deficiency in the European Union.
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Bristol Myers Squibb Receives Positive CHMP Opinion for Anti-BCMA CAR T Cell Therapy Abecma (idecabtagene vicleucel) for Relapsed and Refractory Multiple Myeloma
6/25/2021
The CHMP adopted a positive opinion based on results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of Abecma in 128 patients with heavily pre-treated and highly refractory multiple myeloma.
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CHMP Recommends Approval of RINVOQ® (upadacitinib) for the Treatment of Atopic Dermatitis
6/25/2021
AbbVie announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of RINVOQ®, an oral, selective and reversible JAK inhibitor, for the expanded use in adults and adolescents 12 years and older with moderate to severe atopic dermatitis who are candidates for systemic therapy.
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Aurinia Announces Licensing Partner Otsuka Filed Initial Marketing Authorization Application (MAA) for Voclosporin with the European Medicines Agency (EMA)
6/25/2021
Aurinia Pharmaceuticals Inc. announced that the Company’s licensing partner, Otsuka Pharmaceutical Europe Ltd., filed an initial Marketing Authorization Application for voclosporin for the treatment of lupus nephritis to the European Medicines Agency. LN is a complication of the autoimmune disease systemic lupus erythematosus that seriously impacts the kidneys.
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Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy
6/25/2021
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
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European Commission Purchases Additional 150 Million Doses of Moderna’s COVID-19 Vaccine for Delivery in 2022
6/22/2021
Moderna, Inc., a biotechnology company pioneering messenger RNA therapeutics and vaccines, announced that the European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine, including the ability to purchase other COVID-19 vaccine candidates from Moderna’s pipeline.
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EMA validates Algenex’ CrisBio® platform for the manufacturing of vaccines
6/22/2021
Algenex SL, a biotech company backed by Cleon Capital and Columbus Ventures delivering disruptive technologies for recombinant biologics production, has taken significant steps towards full commercialisation of its CrisBio® platform through the first recommendation for approval by a global regulator of a biological produced with the system.
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Day One Receives Orphan Designation from the European Commission for DAY101 for the Treatment of Glioma
6/21/2021
Day One Biopharmaceuticals, a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for patients of all ages with genetically defined cancers, announced that the European Commission has granted orphan designation for the Company’s lead product candidate, DAY101, for the treatment of glioma.
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The FDA said that the drug, which has been studied and submitted for NPC indication, needs further data to support its use in this rare, progressive genetic disorder.
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The failure marks a setback in the hunt for means other than vaccines to provide protection against the novel coronavirus and its variants.
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The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria.
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Soligenix Receives Pediatric Investigational Plan Waiver for HyBryte™ in CTCL from the European Medicines Agency
6/10/2021
Soligenix, Inc. announced today that it has received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA).
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The FDA lifted the clinical holds on bluebird bio’s sickle gene therapy and its betibeglogene autotemcel gene therapy for adults, adolescents and children with TDT.
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The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
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Seelos Therapeutics Receives European Orphan Drug Designation for SLS-005 (Trehalose) in Amyotrophic Lateral Sclerosis (ALS)
5/27/2021
Seelos Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced it has received European Orphan Drug Designation for SLS-005 in amyotrophic lateral sclerosis from the European Medicines Agency Committee for Orphan Medicinal Products.
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The EUA was granted base on interim data from the Phase III COMET-ICE trial in high-risk adult outpatients.
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This is after Larimar reported deaths in the highest dose levels of a nonhuman primate toxicology study.