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Novartis scores EU nod for gene therapy Luxturna fiercepharma
November 28, 2018
It’s been almost a year since Spark Therapeutics won a groundbreaking gene therapy approval in the U.S. for Luxturna, and now its marketing partner Novartis has done the same across the pond.
Italy free to reimburse off-label Avastin, rules EU court pharmaphorum
November 28, 2018
Novartis and Roche’s long-running battle to try to prevent off-label prescribing of Roche’s Avastin in place of their approved Lucentis product for the eye disease age-related macular degeneration (AMD) has been dealt a blow by the European Court of Justi
EU green light for Takeda’s Alunbrig pharmatimes
November 28, 2018
Takeda’s Alunbrig has been approved in Europe as a treatment for a specific group of lung cancer patients, but access to the drug in the UK remains uncertain.
Novartis/Spark’s sight gene therapy approved in EU pharmaphorum
November 27, 2018
Spark Therapeutics’ gene therapy for a rare inherited sight disorder, Luxturna has been approved in Europe, but there was still no word on price from marketing partner Novartis.
With EU blessing, Takeda clears final regulatory hurdle for Shire buyout—on one condition fiercepharma
November 26, 2018
Following major regulators in the U.S., China and Japan, the European Commission has given Takeda the go-ahead for its $62 billion acquisition of Shire—on one condition that Takeda is willing to fulfill.
EU approves Camurus’s Buvidal injections to treat opoid dependency pharmaceutical-technology
November 25, 2018
Swedish research-based pharmaceutical and biotechnology company Camurus has received European Commission (EC) approval for weekly and monthly Buvidal injections to treat opioid dependency in adults and teenagers from 16 years of age.
Roche pulls EU application for Tecentriq in kidney cancer biopharmadive
November 22, 2018
Roche has withdrawn an application to the European Medicines Agency that sought an expanded approval for its immunotherapy Tecentriq in advanced kidney cancer, concluding in a letter to the regulator data were insufficient to support a label extension.
With EU blessing, Takeda clears final regulatory hurdle for Shire buyout—on one condition fiercepharma
November 22, 2018
Following major regulators in the U.S., China and Japan, the European Commission has given Takeda the go-ahead for its $62 billion acquisition of Shire—on one condition that Takeda is willing to fulfill.
EU approves Ipsen’s Cabometyx in second line liver cancer pharmaphorum
November 21, 2018
The European Commission has approved Ipsen’s Cabometyx for liver cancer, in adults previously treated with Bayer’s Nexavar.
EU rules may be stifling Britain's biotech industry pharmafile
November 20, 2018
EU rules are stifling Britain’s biotech industry, according to companies who talked to British newspaper The Daily Telegraph.

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