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Biofrontera Receives FDA approval for Upscaling of Batch Size for Ameluz Production americanpharmaceuticalreview
January 09, 2019
Biofrontera announced the U.S. Food and Drug Administration (FDA), and earlier the European Medicines Agency (EMA), have approved the upscaling of the batch size for the production of Ameluz to 35 kg from previously 7 kg....
AbbVie seeks US and European authorisations for upadacitinib pharmaceutical-technology
December 24, 2018
AbbVie has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), seeking approvals for .....
Roche gets PRIME designation for SMA drug in Europe pharmaceutical-technology
December 20, 2018
Roche has secured PRIME designation from the European Medicines Agency (EMA) for its risdiplam (RG7916) medicine to treat spinal muscular atrophy (SMA).
Pfizer’s cut-price version of Avastin wins EU panel greenlight expressbpd
December 18, 2018
Pfizer’s Zirabev is a cheaper version to Roche Holding’s leading cancer drug Avastin
Novartis withdraw marketing application for heart drug pharmafile
December 18, 2018
Swiss multinational Novartis has withdrawn a European Medicines Agency (EMA) marketing application for canakinumab for the prevention of serious events such as stroke, myocardial infarction (MI) or death in patients who have had an MI.
Novartis pulls EU filing for canakinumab pharmatimes
December 18, 2018
Novartis has pulled back its application to market canakinumab for the prevention of serious events such as stroke, myocardial infarction (MI) or death in patients who have had an MI in Europe.
Seven medicines leap closer to EU approval pharmatimes
December 18, 2018
The European Medicines Agency’s human medicines committee (CHMP) has put forward seven medicines for approval in the region.
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.....
Daiichi Sankyo claims speedy review for AML drug in Europe pharmaphorum
December 13, 2018
Japan’s Daiichi Sankyo is looking at a reduced review time for its acute myeloid leukaemia (AML) drug quizartinib in Europe, the top prospect in its new oncology pipeline.....
EMA, GSK blast BMJ’s ‘flawed’ Pandemrix safety report fiercepharma
December 11, 2018
European drug regulatory bodies and GlaxoSmithKline have quickly rallied their rebuttals to a BMJ report that questioned the safety profile of GSK’s now-unavailable pandemic flu vaccine Pandemrix...

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