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EU steps closer to generics and biosimilars manufacturing waiver
pharmaphorum
February 28, 2019
A change to European rules on drug manufacturing that could benefit makers of generics and biosimilars is edging closer, after lawmakers agreed draft legislation that tweaks rules on export and manufacture of drugs that are off-patent outside the EU.
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EU measures in support of generic pharmaceuticals producers
europeanpharmaceuticalreview
February 22, 2019
The EU is adopting new rules which should boost the competitiveness of EU producers of generic medicines and biosimilar products…
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Public consultation on key principles for ePI of EU medicines
europeanpharmaceuticalreview
February 02, 2019
The European Medicine Agency, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a six-month public consultation on draft key principles...
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Sandoz inks biosimilars commercialization deal with Gan & Lee Pharmaceutical
biospectrumasia
January 07, 2019
Sandoz, recently announced that it has entered into an agreement with Gan & Lee Pharmaceutical to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes.
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EU & NICE authorise MSD's Keytruda for stage III melanoma
pharmatimes
December 20, 2018
MSD’s Keytruda has been given a green light for use within the EU as an adjuvant treatment for stage III melanoma, and has also been made available on the NHS.
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CHMP Grants Positive Opinion for New Indication of Rubraca
americanpharmaceuticalreview
December 17, 2018
Clovis Oncology announced the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending.....
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83% in healthcare say UK will not be attractive for R&D and manufacturing post-Brexit
pharmafile
December 03, 2018
As the Brexit crisis continues to spiral, new findings from GlobalData reveal that 83% of healthcare professionals in the UK believe that the country will no longer present an attractive destination
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EU approves Kyowa Kirin’s drug for rare lymphoma
pharmaphorum
November 30, 2018
The European Commission has approved Poteligeo (mogamulizumab), a treatment for rare types of non-Hodgkin’s lymphoma.
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Novartis Announces EU Approval of Gilenya
americanpharmaceuticalreview
November 30, 2018
Novartis announced the European Commission (EC) has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms
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Camurus Receives EU Approval for Weekly and Monthly Buvidal
americanpharmaceuticalreview
November 29, 2018
Camurus announced the European Commission (EC) has approved weekly and monthly Buvidal (prolonged release buprenorphine) for the treatment of opioid dependence in adults and adolescents from 16 years of age. .....