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CHMP

Europe’s CHMP regulatory committee has new chair

Europe’s CHMP regulatory committee has new chair

Europe’s top drugs regulatory committee has a new leader after Dr Tomas Salmonson stepped down as chair of

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Europe’s CHMP regulatory committee has new chair

https://pharmaphorum.com/news/europes-chmp-regulatory-committee-has-new-chair/

Takeda finalises buyout of TiGenix

Takeda finalises buyout of TiGenix

Japanese pharma giant Takeda has completed its buyout of TiGenix. Takeda’s main R&D focus is in oncology, gastroenterology

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Takeda finalises buyout of TiGenix

https://pharmaphorum.com/news/japanese-takeda-finalises-tigenix-boyout/

Vertex and Alnylam orphan drugs set for EU approval

Vertex and Alnylam orphan drugs set for EU approval

Orphan drugs for cystic fibrosis and the hereditary rare disease hATTR are on course for European approval after

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Vertex and Alnylam orphan drugs set for EU approval

https://pharmaphorum.com/market-access-2/chmp-vertex-symkevi-alnylam-onpattro/

Fourth Humira biosimilar set for EU approval

Fourth Humira biosimilar set for EU approval

European regulators have backed a new Humira biosimilar for approval, setting up a four-way race for the blockbuster’s

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Fourth Humira biosimilar set for EU approval

https://pharmaphorum.com/news/humira-biosimilar-eu-sandoz-chmp/

EU cancer drugs rejection shows contrasts with FDA

EU cancer drugs rejection shows contrasts with FDA

Europe’s expert medicines panel has rejected Puma Biotechnology’s breast cancer drug neratinib, citing limitations in its efficacy and safety

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EU cancer drugs rejection shows contrasts with FDA

https://pharmaphorum.com/news/eu-rejection-cancer-drugs-shows-differences-fda/

Europe recommends Tecentriq in bladder cancer, but efficacy doubts persist

Europe recommends Tecentriq in bladder cancer, but efficacy doubts persist

The European Union’s CHMP committee recommended 11 medicines on Friday, including five orphan drugs. Among the most notable

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Europe recommends Tecentriq in bladder cancer, but efficacy doubts persist

https://pharmaphorum.com/news/europes-chmp-recommends-tecentriq-doubts-efficacy-persist/

PTC’s muscular dystrophy drug can stay on EU market – regulators

PTC’s muscular dystrophy drug can stay on EU market – regulators

But PTC must conduct further trial to confirm Translarna’s benefits.

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PTC’s muscular dystrophy drug can stay on EU market – regulators

https://pharmaphorum.com/news/ptcs-muscular-dystrophy-drug-can-stay-on-market-regulators/

Lilly soft tissue cancer drug gets EU nod

Lilly soft tissue cancer drug gets EU nod

Regulators conditionally back Lartruvo, based on mid-stage data.

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Lilly soft tissue cancer drug gets EU nod

https://pharmaphorum.com/news/lilly-soft-tissue-cancer-drug-gets-eu-nod/

Sandoz, Teva and Mylan generics to be suspended in EU

Sandoz, Teva and Mylan generics to be suspended in EU

Regulator concerned over data from contract research organisation.

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Sandoz, Teva and Mylan generics to be suspended in EU

https://pharmaphorum.com/news/eu-regulator/

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