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- PMLiVE

AZ, Amgen file first-in-class asthma drug with the FDA

Submission is based on positive results from the companies’ PATHFINDER clinical programme

- PMLiVE

AZ, Daiichi Sankyo reveal new TNBC data for next-gen antibody drug conjugate

Datopotamab deruxtecan shows early promise in heavily pre-treated patient group

- PMLiVE

EMA launches rolling review of GSK/Vir Biotech’s mAb for early COVID-19

Rolling review supported by interim analysis of data from phase 3 COMET-ICE trial

- PMLiVE

FDA approval for Keytruda/Herceptin combination in first-line advanced gastric cancer

Approval is based on positive overall response rate (ORR) data from KEYNOTE-811 trial

- PMLiVE

Merck & Co reveals plans for women’s health spinoff Organon

Company is expecting tax-free dividend of $9bn following close of spinoff

- PMLiVE

AstraZeneca reports ‘strong’ Q1 results, forecasts accelerated growth in 2021

Company is ‘well-positioned for a high growth year’, according to analyst

- PMLiVE

GSK’s revenue drops by 18% in Q1 as performance pressures mount

Chief executive Emma Walmsley said results ‘reflect the anticipated impacts of COVID-19’

- PMLiVE

Novartis announces delay in UK cholesterol drug study

The delay was caused by recruitment issues during the COVID-19 pandemic

- PMLiVE

AZ, Sanofi’s nirsevimab hits primary endpoint in RSV trial

Drug reduced lower respiratory tract infections caused by respiratory syncytial virus in infants

- PMLiVE

EU moves forward with legal action against AZ over vaccine supply issues

Legal proceeding launched on the basis of 'breaches of the advanced purchase agreement'

- PMLiVE

J&J resumes US rollout of single-dose COVID-19 vaccine

CDC and FDA recommended pause be lifted after ‘rigorous review’ of very rare blood clots

- PMLiVE

GSK wins approval for anti-PD-1 antibody Jemperli in endometrial cancer

AnaptysBio earns a $20m milestone payment on approval after originally developing the drug

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