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- 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

Eli Lilly/AbCellera’s COVID-19 variant-targeting antibody enters clinical trials

Drug will be evaluted alone and together with other monoclonal antibodies in the expanded BLAZE-4 trial

- PMLiVE

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

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

- PMLiVE

Lilly cuts 2021 guidance to reflect ‘lower expected revenue’ from COVID-19 antibody sales

FDA recently removed emergency authorisation for bamlanivimab monotherapy

- 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

- PMLiVE

EU may seek legal action against AstraZeneca following vaccine supply cuts

EU supply issues for the AZ vaccine started in January 2021

- PMLiVE

J&J halts manufacturing of COVID-19 at US plant after FDA warning

Inspection report found facility was “not maintained in a clean and sanitary condition”

- PMLiVE

Valneva to compare its COVID-19 vaccine candidate to AstraZeneca’s jab

Phase 3 trial will test Valneva’s vaccine candidate against Vaxzevria in approximately 4,000 participants

- PMLiVE

Lilly asks to revoke emergency authorisation for bamlanivimab monotherapy in the US

Decision prompted by the ‘evolving variant landscape’ in the US

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