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Celltrion secures EC approval for Remsima SC for five more indications
pharmaceutical-business-review
July 29, 2020
Celltrion Healthcare has secured approval from the European Commission (EC) for the subcutaneous (SC) formulation of autoimmune disease drug Remsima (infliximab, CT-P13) for the treatment of five more indications.
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EC approves new indication for Boehringer’s nintedanib in pulmonary fibrosis
pharmaceutical-business-review
July 17, 2020
Boehringer Ingelheim has secured approval for a new indication of nintedanib to treat adults with other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).
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Novartis receives EC approval for Enerzair Breezhaler
americanpharmaceuticalreview
July 16, 2020
Novartis announced the European Commission (EC) has approved Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) as a maintenance treatment of asthma in adult patients not adequately ...
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CureVac recieves €75 million loan for vaccine development and manufacturing expansion
europeanpharmaceuticalreview
July 09, 2020
The European Investment Bank (EIB) will provide three €25 million instalments to support CureVac’s vaccine development and expansion to mRNA production facilities.
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Novartis banks EC approval for Enerzair Breezhaler
pharmatimes
July 08, 2020
The European Commission (EC) has approved Novartis' Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate) for uncontrolled asthma.
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FDA, EC Partner on COVID-19 Response
americanpharmaceuticalreview
July 07, 2020
The European Union (EU) is one of the U.S. Food and Drug Administration’s most important collaborators in tackling public heath challenges.
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Gilead gets EC conditional approval for remdesivir to treat Covid-19
pharmaceutical-technology
July 07, 2020
The European Commission (EC) has provided conditional marketing authorisation for Gilead Sciences to use Veklury (remdesivir) for the treatment of Covid-19.
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Further billions pledged to ensure equitable access to COVID-19 treatments
europeanpharmaceuticalreview
July 03, 2020
The European Investment Bank (EIB), in partnership with the European Commission (EC), have pledged an additional €4.9 billion for use in the global coronavirus response funds.
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Janssen’s Ebola vaccine secures European regulatory approval
pharmaceutical-technology
July 03, 2020
Johnson & Johnson unit Janssen Pharmaceutical Companies has received marketing authorisation from the European Commission (EC) for its vaccine regimen designed to prevent Ebola Virus Disease.
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Pfizer gets EC approval for Daurismo to treat newly diagnosed acute myeloid leukaemia
pharmaceutical-business-review
July 02, 2020
Pfizer has secured approval from the European Commission (EC) for its Daurismo (glasdegib) to treat certain adult patients with newly diagnosed acute myeloid leukaemia (AML).