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EU calls for global alliance to buy COVID-19 vaccines up front expresspharma
June 18, 2020
It is planning to spend around $2.3 billion on the advance purchase of vaccines in testing on behalf of the 27 EU states.
EU expands reach of Vertex' CF drug Kalydeco pharmatimes
June 11, 2020
EU regulators have expanded the treatment scope of Vertex' Kalydeco (ivacaftor) to include a new subset of young patients with cystic fibrosis (CF).
EU plans permanent stockpile of essential drugs, medical gear expresspharma
June 01, 2020
The stockpile would be funded from a new health budget worth 9.4 billion euros ($10.3 billion) which the EU executive commission proposed.
EU regulators approve Takeda's Adcetris for sALCL pharmatimes
May 15, 2020
European regulators have approved Takeda's Adcetris (brentuximab vedotin) for use in adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) in combination with CHP (cyclophosphamide, doxorubicin, prednisone).
EU GMP Certification for Biocon Biologics Drug Substance Facilities in Bengaluru expresspharma
May 14, 2020
These facilities were inspected by the regulatory agency between January 20 and 23, 2020.
Cosentyx Gains Fourth indication in EU for Axial Spondyloarthritis Spectrum americanpharmaceuticalreview
May 05, 2020
Novartis announced the European Commission (EC) has approved Cosentyx® (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
Expanded EU approval for Takeda's Alunbrig pharmatimes
April 10, 2020
European regulators have expanded the scope of Alunbrig (brigatinib) to include its use as a monotherapy for the treatment of adults with anaplastic lymphoma kinase-positive (ALK+) ...
Takeda gets EU approval for ALUNBRIG in ALK+ NSCLC pharmaceutical-business-review
April 09, 2020
Takeda Pharmaceutical has secured expanded approval for ALUNBRIG (brigatinib) in the European Union (EU) to use the tyrosine kinase inhibitor for the treatment of a particular lung cancer population.
EU authorities agree new measures to support the pharma supply chain during COVID-19 pandemic europeanpharmaceuticalreview
April 09, 2020
The European Medicines Agency (EMA) and other authorities have created a new shortage reporting system and are looking into how regulations can be applied more flexibly during the COVID-19 pandemic.
Expanded EU approval for Takeda's Alunbrig pharmatimes
April 08, 2020
European regulators have expanded the scope of Alunbrig (brigatinib) to include its use as a monotherapy for the treatment of adults with anaplastic lymphoma kinase-positive (ALK+) ...

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