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TDF

- PMLiVE

Combatting EU drug shortages

New guidelines to be issued after EMA report

EISAI

Eisai wins EU licence for kidney cancer drug Kisplyx

Approved as a second-line combination treatment for advanced RCC

- PMLiVE

Newron back on track for Xadago approval in US

Italian firm is not required to conduct additional trials for its Parkinson’s disease drug

- 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

Keytruda cleared in Europe for lung cancer

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

- PMLiVE

Gilead launches European hep C awareness drive

Aims to highlight significance of cure through patient storytelling initiative

Brextinction

Evolution predicts tragic consequences from the UK's choice

Gilead Sciences

Gilead’s hepatitis C sales start to slide – the question is how quickly?

CEO anticipates eventual “equilibrium” through shift toward treatment of less severely ill patients

- PMLiVE

HIV prevention pill heads July CHMP recommendations

Gilead’s Truvada given positive opinion alongside Ipsen Pharma’s Cabometyx and Eisai’s Kisplyx

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

Bristol-Myers Squibb (BMS) building

Opdivo moves closer to head and neck cancer approval

Possible US verdict by November for BMS’ ‘breakthrough’ SCCHN therapy

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