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- PMLiVE

2019-nCoV

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FDA accepts Regeneron’s REGEN-COV for priority review for treatment of COVID-19

In Europe, the EMA will review a Marketing Authorisation Application for the antibody cocktail

- PMLiVE

AstraZeneca requests Emergency Use Authorization from FDA for COVID-19 antibody

Phase 3 data shows the long-acting antibody combination produces a 77% reduction in the risk of developing symptomatic COVID-19

- PMLiVE

Merck and Ridgeback’s oral antiviral halves COVID-19 risk of hospitalisation or death

The phase 3 study shows the risk was halved compared to placebo for patients with mild or moderate COVID-19

- PMLiVE

Sanofi refocuses COVID-19 efforts away from mRNA

Trial data validates Sanofi’s mRNA and lipid nanoparticle platform but the company will not pursue its own mRNA COVID-19 vaccine

- PMLiVE

COVID-19 Pfizer/BioNTech booster approved by FDA and CDC

The plan to offer Americans a third, booster shot of the Pfizer/BioNTech COVID-19 vaccine has finally been waved through by the FDA and CDC

- PMLiVE

New data from Moderna supports COVID boosters

Waning immunity from its mRNA jab “support benefit” of a booster shot, says Moderna, while international scientists publish plea for evidence over politics

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EU “still interested” in Valneva COVID vaccine despite UK snub

Negotiations between Valneva and the EU are “ongoing and advanced”, with its vaccine candidate VLA2001 touted as a potential booster shot in France

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US orders 1.4 million more doses of Regeneron antibody cocktail

The new $2.9bn order increases the amount of Regeneron’s anti-COVID REGEN-COV purchased by the US government to nearly 3 million doses

- PMLiVE

FDA’s director and deputy director of its Office of Vaccines Research & Review resign

The departure of director Marion Gruber and deputy director Philip Krause is unexpected

- PMLiVE

GSK/SK bioscience COVID-19 vaccine to enter phase 3 trial

The study will be one of the first global phase 3 trials to compare two different COVID-19 vaccine candidates

- PMLiVE

Pfizer/BioNTech file for FDA approval for COVID-19 booster jab

New data shows third dose boosts antibodies by more than three times

- PMLiVE

Valneva’s COVID-19 vaccine to be tested in older people

The trial for VLA2001 will involve people over the age of 56 in New Zealand and aims to generate additional safety and immunogenicity data in older people

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