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- PMLiVE

Legend Biotech

EISAI

Eisai wins EU licence for kidney cancer drug Kisplyx

Approved as a second-line combination treatment for advanced RCC

- PMLiVE

Lundbeck challenge to EC pay-for-delay ruling fails

Court upholds €94m fine for paying off firms to delay launch of Celexa generics

- PMLiVE

Biogen launches Remicade biosimilar in the UK

Flixabi provides another low-cost alternative to J&J’s biggest-selling drug

- PMLiVE

Keytruda cleared in Europe for lung cancer

New second-line indication for Merck’s drug puts it in direct competition with BMS’ Opdivo

EU flag

EU proposes reforms to make first-in-human trials safer

New guideline revision paper “takes into account lessons learnt” from fatal Bial trial

- PMLiVE

EU clears AZ’s FDA-rejected diabetes combination

Approval of two-drug therapy Qtern presents first-to-market advantage in Europe

- PMLiVE

Celgene’s Revlimid cleared for aggressive lymphoma type in EU

Analysts anticipate sales of up to $10bn for the newly-expanded drug in coming years

EU flag

EC approves Bial’s Parkinson’s disease therapy

Ongentys will be given a phase roll-out in 2016 and 2017

- PMLiVE

Amgen’s Kyprolis wins new indication in Europe

Regulators have handed the treatment a less restrictive licence in multiple myeloma 

- PMLiVE

AZ gets EU green light for new antibiotic Zavicefta

EMA approves combination drug for treatment of multidrug resistant infections

- PMLiVE

Takeda hands back rights to two Amgen drugs

Returns pain and ovarian cancer candidates but will continue with collaboration

Gilead Sciences

Gilead gets EU nod for TAF-based triple therapy for HIV

Once-daily, single-tablet Odefsey reduces risks of side effects such as renal and bone toxicity

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