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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

The agency proposes that pharma move away from the common maximum tolerated dose (MTD) to trial designs that prioritise drug dosage optimisation at different stages. In clinical trials, dose-ranging is testing different drug doses against each other to establish which works best.

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Epsilogen completes first-ever IgE antibody clinical trial

BioPharma Reporter

Epsilogen, a leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, has published phase 1 data from the first ever clinical trial of an IgE antibody therapeutic in Nature Communications.

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What Are the Top Oncology Clinical Trial Trends Through the Lens of ESMO?

XTalks

Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include.

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Phase I clinical trial for first-in-class bispecific antibody for cancer treatment 

Drug Discovery World

Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress.

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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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Monoclonal Antibody Lecanemab Finalizing Clinical Trials for Alzheimer’s Disease Treatment

XTalks

This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? The Phase IIb clinical trial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). The main pathological markers of AD are beta-amyloid (A?)

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Antibody treatment for geographic atrophy enters clinical trials

Drug Discovery World

Collaborators Boehringer Ingelheim and CDR-Life have commenced a Phase I evaluation of BI 771716, their antibody fragment-based treatment developed to preserve the vision of people with geographic atrophy (GA). The company’s first therapeutic candidate, CDR404, targets MAGE-A4 and is expected to enter the clinic in 2024.