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GSK to assist in manufacturing up to 60 million doses of Novavax’s COVID-19 vaccine in the UK

Vaccine candidate is expected to be submitted to UK regulatory authorities in Q2

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Lilly, Vir and GSK’s antibodies reduce viral load by 70% in low-risk COVID-19 patients

The two neutralising antibodies bind to different epitopes of the SARS-CoV-2 spike protein

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J&J’s MS drug ponesimod receives approval in the US

US regulator has approved the drug – now named Ponvory – for relapsing forms of MS

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FDA accepts BMS’ investigational cardiovascular drug mavacamten for review

BMS gained the rights to mavacamten as part of its acquisition of MyoKardia

- PMLiVE

GSK and Medicago initiate late-stage COVID-19 vaccine study

Plant-based, adjuvanted vaccine candidate received FDA fast track designation in February

- PMLiVE

GSK, Vir seek EUA after scoring positive results for COVID-19 antibody VIR-7831

VIR-7831 reduced the risk of hospitalisation/death by 85% in high-risk COVID-19 patients

- PMLiVE

GSK, Vir halt enrolment of phase 3 COVID-19 antibody study

Move comes after recommendation from independent data and safety monitoring board

- 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

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

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