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Pace of cancer drug reimbursement varies wildly across Europe
pharmaceutical-technology
October 22, 2018
Researchers have found that some European countries take more than twice as long as others to reach health technology assessment (HTA) decisions about reimbursing cancer drugs following European Medicines Agency (EMA) approval.
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Trial takes FibroGen’s renal anemia drug closer to EU filing
fiercebiotech
September 21, 2018
Roxadustat outperformed placebo in its ability to boost hemoglobin levels
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Europe ‘needs uniform policy’ to help generic pharmaceuticals market grow: report
europeanpharmaceuticalreview
September 05, 2018
A Europe-wide policy covering the generic pharmaceuticals market would significantly boost growth in the sector, reveals a new report from Frost & Sullivan.
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First treatment for lipodystrophy approved in Europe
pharmatimes
August 02, 2018
Aegerion Pharmaceuticals' Myalepta, a treatment for the ultra-rare condition lipodystrophy, has been approved by the EC as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy patients.
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MSD's ulcerative colitis drug scores expanded indication in Europe
pharmafile
July 17, 2018
New Jersey-based multinational MSD have announced that the European Commission (EC) has approved Simponi (golimumab) for early dose optimisation in ulcerative colitis (UC) for patients with body weight less than 80kg who do not respond adequately to induc
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Europe recalling some valsartan meds on safety fears
pharmatimes
July 16, 2018
The European Medicines Agency is reviewing medicines containing valsartan supplied by a facility in China after a potentially cancer-causing impurity was detected.
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Herceptin biosimilar Herzuma launched in Europe
pharmatimes
May 07, 2018
Mundipharma said its network of companies has kicked off the rollout of Celltrion’s Herceptin biosimilar Herzuma in Europe.
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Europe's biggest private biotech company raises $270 million
en-cphi.cn
February 06, 2018
BioNTech has raised $270 million to support its work in developing personalized immunotherapies for cancer, ahead of an expected eventual stock market flotation.
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Kite Pharma submits MAA for axicabtagene ciloleucel in Europe
pharmaceutical-technology
August 03, 2017
US-based cell therapy company Kite Pharma has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel.
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New hepatitis C therapies approved in Europe
pharmatimes
August 01, 2017
Patients with hepatitis C in Europe could soon gain access to two new pan-genotypic treatment options after the European Commission issued approval for AbbVie’s Maviret and Gilead’s Vosevi following an accelerated review.