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- PMLiVE

Vaccine developers call on FDA to offer clarity on COVID-19 trials

Comments from J&J and Pfizer made before FDA advisory committee meeting yesterday

- PMLiVE

Independent consultant will review Lilly’s COVID-19 plant issues

COVID-19 antibody trial was paused last week due to safety issue

- PMLiVE

Novartis scores CHMP backing for cholesterol drug Leqvio

Potential first-in-class treatment moves closer to EU approval

- PMLiVE

Regeneron scores first FDA approval for Ebola antibody treatment

Treatment cut mortality rate in study based in the Democratic Republic of Congo

- PMLiVE

Regeneron seeks US emergency use authorisation for COVID-19 antibody cocktail

If approved, the US government will make initial doses available at no cost

- PMLiVE

FDA publishes new guidelines for COVID-19 vaccine approval

New rules mean a COVID-19 shot is unlikely to be approved pre-election in the US

- PMLiVE

EU announces agreement with Gilead for remdesivir supply

Drug was granted conditional marketing authorisation in the EU in July

- PMLiVE

J&J signs deal with EU for 200 million COVID-19 vaccine doses

EU member states will have an option to secure 200 million additional doses

- PMLiVE

Lilly seeks US emergency approval after posting new data for COVID-19 antibodies

Combination of two antibodies reduced viral load and symptoms of COVID-19

- PMLiVE

Pfizer and BioNTech’s COVID-19 vaccine begins EMA evaluation

Vaccine is the second to undergo EMA's 'rolling review' process after AstraZeneca/Oxford Uni's candidate

- PMLiVE

Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November

Company will seek emergency use authorisation for experimental vaccine

- PMLiVE

EMA begins rolling review of AZ’s COVID-19 vaccine candidate

Agency has started evaluating data from non-clinical laboratory studies

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