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- PMLiVE

Novartis, Bayer announce separate agreements to bolster COVID-19 vaccine manufacturing

Novartis will help manufacture Pfizer/BioNTech's vaccine and Bayer will do the same for CureVac's vaccine

- PMLiVE

Novartis hit by ‘COVID-19-related lockdowns’ in Q4

Sales grew in the quarter but profits fell short of forecasts

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UPDATED: Gilead says remdesivir likely to be effective against new COVID-19 strains

FDA approved the antiviral drug for the treatment of hospitalised COVID-19 patients in October 2020

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Janet Woodcock named acting commissioner of the FDA

President Biden is set to formally nominate a commissioner soon

- PMLiVE

BMS aims for US approval of Opdivo combo in stomach cancer

US regulator has set a goal date for a decision on 25 May

- PMLiVE

New dosing option for AZ’s Imfinzi approved in the EU and UK

Additional option extends dosing from two weeks to four weeks

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Bayer’s finerenone scores FDA priority review for chronic kidney disease

FDA priority review is based on data from the phase 3 FIDELIO-DKD trial

- PMLiVE

Biogen advances Spinraza study in SMA patients treated with Novartis’ Zolgensma

Study will enrol patients who have ‘unmet clinical needs’ after receiving gene therapy

- PMLiVE

Roche’s tiragolumab plus Tecentriq combo wins FDA breakthrough therapy designation

Swiss pharma is aiming for approval in first-line NSCLC

- PMLiVE

FDA will not alter dosing schedules for authorised COVID-19 vaccines

Time period between first and second vaccines has been extended in the UK

- PMLiVE

Inovio plans late-stage COVID-19 vaccine study in second quarter 2021

FDA had placed trial on a temporary hold in September 2020

- PMLiVE

FDA approves Myovant’s oral pill Orgovyx for prostate cancer

This is a new option for advanced prostate cancer patients in the US

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