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

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

- PMLiVE

Merck & Co to help produce J&J’s COVID-19 vaccine in the US

Company has signed agreements to bolster vaccine manufacturing capacity

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MSD withdraws Keytruda’s US indication for small cell lung cancer

Checkpoint inhibitor gained accelerated approval in 2019

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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

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

Vaccine can be transported/stored at standard pharmaceutical freezer temperatures

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Merck to acquire Pandion Therapeutics for $1.85bn

Merck will gain a pipeline of immune modulators targeting autoimmune diseases

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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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Sanofi, Regeneron’s Libtayo scores first-line NSCLC approval in the US

New approval will see Libtayo compete with blockbuster immunotherapy Keytruda

- PMLiVE

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

Submission is based on results from the pivotal REACH3 study

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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

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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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