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US COVID-19 booster programme expanded

The FDA and CDC have given the green light to an expansion of the US COVID-19 booster programme to include another shot of the Moderna and J&J vaccines as well...

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Valneva COVID-19 vaccine more effective than AZ

Valneva will seek regulatory approval in the UK and European Union after its COVID-19 vaccine candidate performed well in phase 3 trials

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Biosimilars boosted by FDA’s landmark ruling for Boehringer’s Cyltezo

The FDA has approved Boehringer’s Cyltezo (adalimumab-adbm) as ‘interchangeable’ with Humira (adalimumab) in a landmark ruling

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AZ’s Imfinzi combination shows promise in liver cancer

Combining Imfinzi with experimental monoclonal antibody tremelimumab improved overall survival in patients with the most common form of liver cancer

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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

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FDA approves Eli Lilly’s Verzenio in high risk early breast cancer

Verzenio is the first addition to adjuvant endocrine therapy approved by the FDA in nearly two decades for the treatment of HR+ HER2- early breast cancer

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Results of AstraZeneca’s TACKLE phase 3 trial show antibody combination reduces risk of severe COVID-19 or death

The antibody is the only long-acting combination shown to both prevent and treat COVID-19

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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

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FDA grants Enhertu Breakthrough Therapy Designation in breast cancer

Phase 3 trial data presented at ESMO shows Enhertu significantly reduced the risk of disease progression or death

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AZ buys Caelum Biosciences for $500m

After AstraZeneca’s Alexion acquires all remaining equity in Caelum next week it will 'advance and accelerate' ongoing clinical development

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Lynparza significantly delays disease progression as first-line treatment in prostate cancer

New data show AstraZeneca and Merck‘s PARP inhibitor, Lynparza, delayed disease progression as a first-line treatment in advanced prostate cancer

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Rocky start for Biogen’s Alzheimer’s drug Aduhelm

Controversial Alzheimer’s treatment Aduhelm is struggling to realise its potential, with only 100 patients receiving the therapy so far in the US

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