European Commission (EC)

220 articles with European Commission (EC)

• Imara Receives Orphan Drug Designation from the European Commission for IMR-687 for the Treatment of Sickle Cell Disease

  8/25/2020

  Imara Inc., a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin, announced that the European Commission granted Orphan Drug designation to IMR-687 for the treatment of patients with sickle cell disease.

• European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury® (remdesivir) for the Treatment of COVID-19

  7/3/2020

  Veklury is the First Approved Treatment Option for COVID-19 in the European Union

• Vivet’s Second Gene Therapy Product, VTX-803 for PFIC3, Receives US and European Orphan Drug Designation

  6/1/2020

  Vivet Therapeutics announced that both the Food and Drug Administration and the European Commission have granted Orphan Drug Designation for Vivet’s second gene therapy product, VTX-803, for the treatment of Progressive Familial Intrahepatic Cholestasis type 3.

• European Commission Approves Subcutaneous Formulation of Entyvio® (Vedolizumab) for use as Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease

  5/8/2020

  Approval makes Entyvio the only maintenance therapy approved across Europe with both intravenous and subcutaneous formulation options for adult patients with ulcerative colitis or Crohn’s disease

• European Commission Approves EVENITY® (romosozumab) For The Treatment Of Severe Osteoporosis In Postmenopausal Women At High Risk Of Fracture

  12/12/2019

  First New Osteoporosis Medicine Approved in the European Union (EU) Since 2010

• Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) in Infants With Cystic Fibrosis Ages 6 Months to Less Than 12 Months With Certain Mutations in the CFTR Gene

  12/10/2019

  Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in children this young

• Aerie Pharmaceuticals Receives European Commission Approval for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%

  11/21/2019

  Aerie Pharmaceuticals, Inc. announced the European Commission has granted a marketing authorisation for Rhokiinsa® 0.02% for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension.

• European Commission Votes in Favor on Nicotinamide Riboside Chloride as a Novel FoodChromaDex achieves milestone for the launch of nicotinamide riboside in Europe

  11/20/2019

  ChromaDex Corp. announced that European Member States have voted in favor of listing Nicotinamide Riboside Chloride as a novel food ingredient at a daily serving of 300mg for the healthy adult population.

• LifeMax Receives Orphan Drug Designation From the European Commission for LM-030 for the Treatment of Netherton Syndrome

  11/13/2019

  LifeMax Laboratories, Inc. announced that the European Commission granted orphan drug designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into a pivotal clinical trial for the treatment of Netherton Syndrome.

• Minoryx Therapeutics receives Orphan Drug Designation from the European Commission for leriglitazone in the treatment of Friedreich’s Ataxia

  11/12/2019

  Second Orphan Drug Designation granted by the European Commission for leriglitazone, in addition to X-linked adrenoleukodystrophy (X-ALD)

• European Commission Approves Astellas' XOSPATA™ for Patients with Relapsed or Refractory Acute Myeloid Leukemia with Mutations Detected using Invivoscribe's LeukoStrat® CDx FLT3 Mutation Assay

  10/30/2019

  Invivoscribe, Inc. announced that the European Commission has approved the Astellas drug XOSPATA™ as a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with FLT3 mutations detected using Invivoscribe's LeukoStrat® CDx FLT3 Mutation Assay..

• European Commission Approves Astellas' XOSPATA™ (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

  10/25/2019

  Approval follows accelerated assessment, orphan designation by European Medicines Agency

• European Commission Approves Expanded Use of Janssen’s STELARA® (ustekinumab) for the Treatment of Moderately to Severely Active Ulcerative Colitis in the European Union

  9/4/2019

  The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission has approved the expanded use of ustekinumab for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

• Dupixent® (dupilumab) Approved by European Commission for Adolescents with Moderate-to-Severe Atopic Dermatitis

  8/6/2019

  Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission extended marketing authorization for Dupixent® in the European Union to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

• EU Healthcare Systems: A Reallocation of Resources is Urgently Needed

  7/11/2019

  Turning away from “low-value” (waste, overuse) towards “high-value” health care is critical for the sustainability of solidarity-based healthcare systems. The Ludwig Boltzmann Institute for Health Technology Assessment is represented on the European Expert Panel.

• LYNPARZA® (olaparib) Approved in the EU for Use as First-Line Maintenance Therapy in Patients With BRCA-Mutated Advanced Ovarian Cancer

  6/18/2019

  AstraZeneca and Merck announced that the European Commission has approved LYNPARZA as monotherapy for the maintenance treatment of adult patients with advanced BRCA1/2-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response following completion of first-line platinum-based chemotherapy.

• Praluent® (alirocumab) now approved in European Union to reduce the risk of cardiovascular events in patients with established cardiovascular disease

  3/15/2019

  Approval is based on ODYSSEY OUTCOMES trial of 18,924 patients who recently suffered an acute coronary syndrome such as a heart attack

• PharmaEssentia and AOP Orphan Receive EU Approval of Besremi™ (Ropeginterferon Alfa-2b) for Treatment of Polycythemia Vera (PV) in EU

  2/21/2019

  PharmaEssentia announced that the European Commission has approved Besremi® as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

• Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease

  1/21/2019

  Lumacaftor/ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis for approximately 1,500 children aged 2 to 5 with two copies of the F508del mutation

• European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Adults with Resected Stage III Melanoma

  12/17/2018

  European Approval Based on Significant Recurrence-Free Survival Benefit Demonstrated with KEYTRUDA in the Pivotal Phase 3 EORTC1325/KEYNOTE-054 Trial