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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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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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Lilly signs $960m deal with Rigel to develop RIPK1 inhibitors

Companies will co-develop molecules for the treatment of immunological and neurodegenerative diseases

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Novartis partners with Bill & Melinda Gates Foundation on ‘accessible’ sickle cell gene therapy

Project will aim to discover and develop a gene therapy for sickle cell disease

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Three strategies for managing loss of exclusivity successfully

Consultant, Claire Taylor explains why you should be strategically planning your LOE strategy years in advance.

Blue Latitude Health

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Rare genetic diseases – what’s in store for 2021?

Why personalised medicine based on our own genomes is the future of healthcare

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ICER extends evaluation of Biogen’s aducanumab after FDA delay

FDA delayed its decision on potential Alzheimer's therapy to 7 June

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FDA grants emergency use for Lilly’s COVID-19 antibody drug combination

Bamlanivimab plus etesevimab shown to reduce risk of death in high-risk COVID-19 patients

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Eli Lilly promotes Anat Ashkenazi to chief financial officer

Ashkenazi previously served as CFO of Lilly Research Laboratories

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FDA considers new safety warnings for Pfizer’s JAK inhibitor Xeljanz

Post-marketing study shows increased risk of serious heart-related problems and cancer with Xeljanz

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FDA schedules meeting on 26 February to review J&J’s one-dose COVID-19 vaccine

Vaccine candidate demonstrated an overall efficacy of 66% in phase 3

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