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- PMLiVE

Eladynos

- PMLiVE

Gilead’s Trodelvy set for EU approval in breast cancer

The positive opinion from EMA’s CHMP means Trodelvy could be available as second-line treatment for unresectable or metastatic breast cancer before the end of the year

- PMLiVE

Amgen’s Biosimilar Trends Report shows benefit of competition from biosimilars

Competition created by biosimilars has delivered $9.8bn in savings over five years and could reduce patients’ out-of-pocket costs by $238m

Biogen Idec building

Biogen’s Vumerity recommended by CHMP in MS

A thumbs up for Vumerity in the EU could ease the way for Biogen’s follow-up to Tecfidera in multiple sclerosis

- PMLiVE

Green light for Amgen’s KRAS inhibitor in the UK

Lumakras – known as Lumykras in the UK – will be available to 600 lung cancer patients in England through an early access scheme.

- PMLiVE

Tezepelumab effective in severe asthma with comorbid nasal polyps

Amgen’s novel drug offers hope to the one-in-five people with severe asthma who also have nasal polyps

- PMLiVE

Amgen pays $900m upfront to acquire Teneobio’s antibody assets, R&D technologies

Amgen will gain antibody technologies designed to discover and develop new molecules with broad applications across therapeutic areas

- PMLiVE

CHMP rejects Kyowa Kirin’s Parkinson’s disease drug

Results of eight main studies of drug were 'inconsistent', according to the CHMP

- PMLiVE

FDA grants priority review for AZ, Amgen’s tezepelumab for asthma

Drug 'has the potential to transform treatment for a broad population of severe asthma patients'

- PMLiVE

CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

- PMLiVE

bluebird bio’s CALD gene therapy Skysona gains positive opinion from CHMP

CHMP's marketing authorisation recommendation is a step towards gaining EU approval

- PMLiVE

US Supreme Court rebuffs Sandoz’s Enbrel biosimilar patent case

Amgen will retain market exclusivity on blockbuster arthritis drug until 2029

- PMLiVE

EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

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