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FDA rejects Regeneron lymphoma drug, setting back company’s oncology push

Bio Pharma Dive

The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.

Antibody 280
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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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Janssen’s antibody drug shows phase 2 potential in rheumatoid arthritis

BioPharma Reporter

The proof-of-concept trial, dubbed IRIS-RA, is the first to investigate a treatment for rheumatoid arthritis that blocks a protein called neonatal Fc receptor (FcRn).

Antibody 105
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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.

Antibody 264
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Corbus and CSPC Megalith sign licence agreement for antibody drug conjugate

Pharmaceutical Technology

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for CRB-701.

Antibody 130
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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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AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug

Bio Pharma Dive

Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway.

Drugs 361