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- PMLiVE

insuline glargine

- PMLiVE

Industry aghast as EU Parliament backs biosimilar rule change

The change could come into effect in 2021

- PMLiVE

Trulicity’s ascent lifts Lilly

Diabetes treatment leads new product growth

Roche Basel Switzerland

Roche submits Kadcyla for FDA Real-Time review

Aims to extend use in breast cancer patients

- PMLiVE

Novo Nordisk preps for speedy oral GLP-1 drug filing

Needs to compete with rival's fast-growing Trulicity

- PMLiVE

Pfizer closes on EU approval of lung cancer drug Vizimpro

And AZ claims first with Forxiga in T1 diabetes

- PMLiVE

European Medicines Agency departs London ahead of Brexit

Regulator moving to Amsterdam, as Novartis adds voice to no-deal warnings

- PMLiVE

EMA says Lilly’s Lartruvo should not be prescribed

First time EMA has acted on accelerated approval follow-up

- PMLiVE

Europe closer to biosimilar rule change, despite fierce resistance from pharma

EFPIA says it weakens IP commitment - supporters say it will boost exports

Sanofi reception

FDA adcomm split on Sanofi’s type 1 diabetes drug

Concerns rose after Zynquista-treated patients showed an eight-fold increase in DKA

- PMLiVE

EMA sees approval numbers rise in 2018

Agency faces Brexit test in 2019

- PMLiVE

Merck’s backing of NGM Bio yields NASH drug deal

Drug has potential in diabetes treatment as well

- PMLiVE

Novartis withdraws EU filing for canakinumab

Further setback for cardiovascular blockbuster potential

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