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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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

COVID-19 Pfizer/BioNTech booster approved by FDA and CDC

The plan to offer Americans a third, booster shot of the Pfizer/BioNTech COVID-19 vaccine has finally been waved through by the FDA and CDC

- PMLiVE

AstraZeneca invests in RNA tech platform

AstraZeneca will support research using VaxEquity’s RNA platform then pay at least $195m for each candidate that enters its pipeline

- PMLiVE

FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer

The drug has been granted accelerated approval, and the companies have also released positive data on first-line treatment

- PMLiVE

AstraZeneca chooses Ireland for $360m manufacturing site

The next-generation facility will make small molecule active ingredients, future-proofing the company’s supply chain and boosting the Irish life sciences sector

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