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- PMLiVE

Kadcyla

Eli Lilly HQ

FDA backs earlier use of Lilly’s breast cancer drug Verzenio

Studies show the drug improves PFS when used with an aromatase inhibitor

- PMLiVE

EMA’s Amsterdam home will not be ready in time

Staff will initially move to a temporary building in the city after Brexit

- PMLiVE

EMA hands UniQure orphan status first in Huntington’s

The Dutch biotech expects to file the treatment for approval later this year

- PMLiVE

Novartis gets speedy reviews for new Kymriah filings

US and EU regulatory agencies will review the drug for DLBCL patients

- PMLiVE

AZ and Merck & Co get FDA breast cancer nod for Lynparza

It becomes the first PARP inhibitor to be approved outside ovarian cancer

- PMLiVE

Novartis bags new breakthrough status for Kisqali in breast cancer

The Swiss pharma group’s treatment will rival Lilly’s Verzenio and Pfizer’s Ibrance if approved

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Issues draft guidance recommending against second-line use in breast cancer

- 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

Novartis raises pressure in Pfizer’s Ibrance with new Kisqali data

Women on Kisqali were found to have a longer PFS than those on hormonal therapy alone

- PMLiVE

Merck pulls Keytruda filing in Europe, despite US approval

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

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