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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.

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Regeneron antibody cuts risk of COVID-19 death in UK study

Bio Pharma Dive

The biotech said it will seek an expanded FDA clearance after results from the RECOVERY trial showed its antibody can lower mortality among certain hospitalized COVID-19 patients.

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AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland

Pharmaceutical Technology

AstraZeneca has signed a deal with the Federal Office of Public Health (FOPH) of Switzerland to deliver over 1,200 doses of antibody therapy, tixagevimab and cilgavimab combination (AZD7442), for Covid-19 prevention and treatment. In June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca.

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Tourmaline shifts focus to developing anti-IL6 antibody following merger

Pharmaceutical Technology

The company plans to initiate the Phase II trial of anti-IL-6 antibody in atherosclerotic cardiovascular disease in 2024.

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Humanised bispecific antibody for asthma enters Phase I trial

Drug Discovery World

Biopharmaceutical company Innovent Biologics has launched the first-in-human (FIH) Phase I clinical trial of IBI3002, a novel bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). In vitro assays have shown superiority over the marketed monoclonal antibodies to respective target.

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Therapeutic antibody potential in 2024

Drug Discovery World

DDW’s Megan Thomas speaks to industry experts and thought leaders about the potential for therapeutic antibodies in 2024. Many of the best-selling drugs in 2023 were monoclonal antibody (mAB) therapies, including Keytruda (pembrolizumab), Humira (adalimumab), and Dupixent (dupilumab) 1.

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FDA lifts two-year clinical hold on CytoDyn’s HIV trial

Pharmaceutical Technology

US FDA placed a partial clinical hold on HIV programme and a full hold on Covid-19 trials for CytoDyn’s monoclonal antibody, leronlimab.

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