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European Commission Drug Approvals

Goodwin

UK’s Medicines Regulator Announces Guidance on the New International Recognition Procedure for the Approval of New Medicines from...

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Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new...more

King & Spalding

EU Aims for Ban of PFAS. Now is the Time to Act.

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Earlier this year, the European Chemicals Agency (ECHA) published a proposal for a ban on the production, use and placing on the market (including import) of at least 10,000 per- and polyfluoroalkyl substances (PFAS)....more

Goodwin

Samsung Bioepis Receives EU Marketing Authorization For Trastuzumab Biosimilar

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Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European...more

Goodwin

European commission approves Sandoz’s Rixathon® (rituximab)

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Sandoz announced today that it has received approval for the use of Rixathon® in Europe. Rixathon® is a biosimilar version of Roche’s MabThera® (rituximab) and is approved for use in all the same indications, including...more

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