European Commission (EC)
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208 articles with European Commission (EC)
European Commission Approves Expanded Use of Janssen’s STELARA® (ustekinumab) for the Treatment of Moderately to Severely Active Ulcerative Colitis in the European Union
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
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.
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
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
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
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
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
European Approval Based on Significant Recurrence-Free Survival Benefit Demonstrated with KEYTRUDA in the Pivotal Phase 3 EORTC1325/KEYNOTE-054 Trial
Children's Hospital Celebrates European Commission Approval of First-of-Its-Kind Gene Therapy for Blindness
CHOP Celebrates Landmark Medical Advance: The First Gene Therapy for a Genetic Disease Approved in Both the U.S. and Europe
Buvidal® is the first long-acting medicine approved in the EU for the treatment of opioid dependence in adults and adolescents
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”).
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.
European Commission approves Ipsen’s Cabometyx® (cabozantinib) for the treatment of hepatocellular carcinoma in adults previously treated with sorafenib
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.
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
A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis
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
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
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.
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.
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.
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...
ONPATTRO Indicated for the Treatment of Hereditary Transthyretin-Mediated (hATTR) Amyloidosis (hATTR amyloidosis) in Adults with Stage 1 or Stage 2 Polyneuropathy