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Trial to test monoclonal antibody for virus of growing concern

Drug Discovery World

The National Institutes of Health (NIH) is sponsoring a clinical trial to evaluate the safety of an investigational monoclonal antibody to treat enterovirus D68 (EV-D68), which can cause severe respiratory and neurological diseases such as acute flaccid myelitis (AFM). Credit: NIAID and CDC.

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Summit, Akeso's antibody triumphs over Keytruda in China lung cancer trial, sending shares skyrocketing

Fierce Pharma

Just one week after Summit Therapeutics and Akeso’s bispecific antibody ivonescimab passed muster with Chinese regulators, the drug has pulled off another feat by staring down the PD-1 king Keytrud | In the phase 3 HARMONi-2 trial, solo ivonescimab delivered a statistically significant and clinically meaningful improvement in progression-free survival (..)

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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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iTeos and GSK hit enrolment milestone with Phase III TIGIT lung cancer trial 

Pharmaceutical Technology

iTeos will receive $35m from GSK as the first patient is dosed in the Phase III trial of the jointly developed monoclonal antibody EOS-448.

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CytoDyn scores $12M in legal battle win: A huge breakthrough for its antibody drug trials

BioPharma Reporter

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

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EHA 2024: Monoclonal antibodies continue to dominate multiple myeloma treatments

Pharmaceutical Technology

Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.

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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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