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Wasdell Begins Operations at EU HQ
contractpharma
July 08, 2019
90,000 sq. ft. facility features 11 production suites, temperature controlled warehouses.
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Fasenra receives positive EU CHMP opinion for self-administration and the new Fasenra pen, a pre-filled, single-use auto-injector
europeanpharmaceuticalreview
July 05, 2019
Fasenra receives positive EU CHMP opinion for self-administration and the new Fasenra pen, a pre-filled, single-use auto-injector.
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Clinical trial sponsors called to publish results on EU database
europeanpharmaceuticalreview
July 05, 2019
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
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AstraZeneca’s Lynparza gets EU nod as first-line ovarian cancer maintenance treatment
expresspharma
June 21, 2019
British drugmaker AstraZeneca announced that its cancer medicine Lynparza was approved as a first-line maintenance treatment for a type of advanced ovarian cancer by the European Commission, following a panel’s consent in April.
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Lynparza approved in EU and Japan for BRCAm ovarian cancer
pharmaceutical-technology
June 20, 2019
Intermediate magnification micrograph of a low malignant potential mucinous ovarian tumour. Credit: Nephron.
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Biocon Biologics receive EU GMP Certification
biospectrumasia
June 16, 2019
This was a surveillance inspection of existing DP and OS facilities and a pre-approval inspection of additional DP manufacturing line
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More countries added to the EU-US mutual recognition agreement
drugs
June 14, 2019
Luxembourg and the Netherlands have been included in the mutual recognition agreement between the EU and the FDA in the US.
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Platform launched to facilitate licensed import of medical cannabis in EU
europeanpharmaceuticalreview
May 24, 2019
The first platform to facilitate the licensed importation of medical cannabis into Europe has formally launched in the UK.
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Is the pharma sector ready for a ‘no-deal’ Brexit?
europeanpharmaceuticalreview
May 17, 2019
Is the pharma sector ready for a ‘no-deal’ Brexit?
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EU approval for Palynziq in adult phenylketonuria
pharmatimes
May 09, 2019
The European Commission has approved BioMarin’s Palynziq (pegvaliase injection) for the treatment of phenylketonuria (PKU) in patients aged 16 years or older.