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- PMLiVE

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AstraZeneca AZ

AZ speeds first-line lung cancer filing for Tagrisso to EMA

As FLAURA trial results show boosted progression-free survival

- PMLiVE

NICE set to reject wider use of Eisai’s Halaven

Issues draft guidance recommending against second-line use in breast cancer

Eisai launches location tracker for dementia patients

Collaborates with Japanese smartphone app network Mamorio on the new tool

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Thomas Dittrich takes up CFO role at Shire

He also joins the Irish biotech’s board

- PMLiVE

EMA forges closer ties with HTA umbrella group

Agrees joint work plan with the European Network for Health Technology Assessment

- PMLiVE

Amsterdam picked to host the European Medicines Agency

But regulator faces a “challenging” relocation project to depart from London

- PMLiVE

Shire wins CHMP backing for Adynovi

Haemophilia A treatment backed for European approval

- PMLiVE

Merck pulls Keytruda filing in Europe, despite US approval

Phase II KeyNote-0241 trial results failed to win over the EMA

- PMLiVE

Shire’s gene therapy candidate receives orphan drug status in the US

Investigational factor VIII treatment SHP654 is being developed for haemophilia

- PMLiVE

Gilead wins European approval for triple hep C combination Vosevi

The treatment brings together sofosbuvir, velpatasvir and voxilaprevir

- PMLiVE

Kite wins FDA approval for blood cancer drug Yescarta

Becomes the first CAR-T therapy approved in the US for B-cell lymphoma

Gilead Sciences promotes Dr Alessandro Riva to EVP, oncology therapeutics

He's been with the firm since January, when he joined from Novartis

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