European Commission (EC)
Rue Joseph II
Jozef II straat 70
Brussels
B-1000
Website: http://europa.eu/
204 articles with European Commission (EC)
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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
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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.
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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
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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
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Children's Hospital Celebrates European Commission Approval of First-of-Its-Kind Gene Therapy for Blindness
12/5/2018
CHOP Celebrates Landmark Medical Advance: The First Gene Therapy for a Genetic Disease Approved in Both the U.S. and Europe
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Camurus Receives EU Approval for Weekly and Monthly Buvidal® (CAM2038) for Opioid Dependence
11/22/2018
Buvidal® is the first long-acting medicine approved in the EU for the treatment of opioid dependence in adults and adolescents
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Takeda Receives Clearance from the European Commission for the Proposed Acquisition of Shire plc
11/20/2018
Takeda Pharmaceutical Company Limited (“Takeda”) announces that it has received clearance from the European Commission (the “EC”) for the proposed acquisition of Shire plc (“Shire”) announced on May 8, 2018 (the “Acquisition”).
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After announcing a potential snag with the European Commission last month, Takeda said this morning that it received clearance for its acquisition of Shire. The clearance is conditional on addressing overlaps in the companies’ inflammatory bowel disease businesses.
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European Commission approves Ipsen’s Cabometyx® (cabozantinib) for the treatment of hepatocellular carcinoma in adults previously treated with sorafenib
11/15/2018
Ipsen today announced that the European Commission (EC) has approved Cabometyx® (cabozantinib) 20, 40, 60 mg as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
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Vertex Announces European Authorization for Third Cystic Fibrosis Medicine SYMKEVI® (tezacaftor/ivacaftor), to be used in combination with ivacaftor (KALYDECO®), for People with CF Aged 12 and Older with Certain Mutations in the CFTR gene
11/1/2018
A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis
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AbbVie Receives European Commission Approval of VENCLYXTO® (venetoclax) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
11/1/2018
The approval is based on the MURANO Phase 3 clinical trial, in which VENCLYXTO® plus rituximab reduced the risk of disease progression or death by 83 percent and overall survival was prolonged compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy regimen¹
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As the acquisition of Shire by Takeda Pharmaceutical inches forward, global regulatory agencies are signing off on the deal. As the European Commission (EC) conducts a review of the deal, it hit a snag.
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Plenty of biotech companies will be releasing their third-quarter financial reports next week. Let’s take a quick look at some of these companies and their top stories they reported through 3Q2018.
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It looks to be a pretty busy week for the U.S. Food and Drug Administration (FDA), with a number of target action dates for various drugs. Some were delayed, and some were already approved, but there are still a number on the schedule. Here’s a look.
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AstraZeneca and MedImmune announced top-line results from its TULIP 1 Phase III clinical trial of anifrolumab in adults with moderate-to-severe systemic lupus erythematosus (SLE). Unfortunately, the drug didn’t meet the trials primary endpoint of statistically-significant reduction in disease act...
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Alnylam Receives Approval of ONPATTRO™ (patisiran) in Europe
8/30/2018
ONPATTRO Indicated for the Treatment of Hereditary Transthyretin-Mediated (hATTR) Amyloidosis (hATTR amyloidosis) in Adults with Stage 1 or Stage 2 Polyneuropathy
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European Commission Commits EUR 2.2m to Launch New Water Safety Technology
8/30/2018
The European Commission selected rqmicro, a Swiss startup company, among more than 1,200 competitors. This financial support accelerates the development and market launch of a revolutionary solution for the rapid detection of pathogenic microorganisms.
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Yescarta® (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy
8/27/2018
New Option for Adult Patients in Europe as Axicabtagene Ciloleucel Becomes the First CAR T to Receive European Approval for Two Types of Aggressive Non-Hodgkin Lymphoma
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Vyxeos® Receives Marketing Authorisation in the European Union for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia
8/27/2018
Jazz Pharmaceuticals plc announced that the European Commission approved Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia
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Pioneers at Children's Hospital of Philadelphia Greet European Commission's Approval of Kymriah as Landmark Medical Advance for Young Cancer Patients in Europe
8/27/2018
Oncologists from Children's Hospital of Philadelphia (CHOP) today celebrated a watershed moment in medicine: approval by the European Commission (EC) of Kymriah