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- PMLiVE

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- PMLiVE

Novavax seeks FDA emergency approval for COVID-19 vaccine by May

Company is hoping FDA will review data from a UK-based trial

- PMLiVE

First shipments of AZ/Oxford COVID-19 vaccine sent through COVAX

First COVAX shipments of vaccine dispatched to Ghana and Cote D’Ivoire

- PMLiVE

UK study finds Pfizer/BioNTech, AZ/Oxford vaccines reduce severe COVID-19 in older people

Data suggests vaccine is 80% effective at preventing hospitalisations in over-80s

- PMLiVE

AZ sells stake in Moderna for around $1.2bn

As Moderna expects COVID-19 vaccine sales to reach $18.4bn this year

- PMLiVE

AZ, Amgen’s tezepelumab reduces asthma exacerbations in broad patient population

Detailed results from the NAVIGATOR trial presented at virtual AAAAI meeting

- PMLiVE

J&J’s one-dose COVID-19 vaccine granted emergency use approval by FDA

Company has already started shipping doses of the vaccine to the US

- PMLiVE

FDA authorises flexible storage for Pfizer/BioNTech COVID-19 vaccine

Vaccine can be transported/stored at standard pharmaceutical freezer temperatures

- PMLiVE

FDA briefing document backs J&J’s one-dose COVID-19 vaccine

Company is seeking an emergency use authorisation in the US

- PMLiVE

FDA updates guidance for COVID-19 vaccine makers addressing new variants

FDA said that it expects manufacturing information for modified vaccines to remain generally the same

- PMLiVE

FDA fast-tracks review of Incyte’s Jakafi for chronic GVHD

Submission is based on results from the pivotal REACH3 study

- PMLiVE

AZ withdraws Imfinzi in the US for advanced bladder cancer after post-marketing study fail

Immunotherapy failed to hit primary endpoint in phase 3 DANUBE trial last year

- PMLiVE

AZ/Merck & Co’s PARP inhibitor Lynparza scores trial win in early breast cancer

Trial halted early after crossing superiority boundary for the primary endpoint of invasive disease-free survival

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