Remove Antibody Remove Clinical Trials Remove Trials
article thumbnail

April 17, 2025: Researchers Illustrate Potential for Observational Studies of Real-World Data to Emulate Randomized Trials

Rethinking Clinical Trials

Researchers applied the “target trial emulation framework” to highlight important design considerations for observational studies that use real-world data to emulate randomized clinical trials. Read the full report. Learn more about the NIH Collaboratory’s Distributed Research Network.

Trials 147
article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy

Bio Pharma Dive

The company is paying China-based biotech LaNova Medicines $588 million for the type of dual-pronged antibody drug that recently bested Keytruda in a clinical trial.

article thumbnail

Bispecific antibody startup Bambusa raises $90m to fund clinical trials

Pharmaceutical Technology

Two of Bambusas bispecific antibody candidates for immunological and inflammatory disorders are set to enter the clinic in 2025.

Antibody 162
article thumbnail

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.

article thumbnail

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
article thumbnail

Lilly's antibody drug prevents COVID-19 in study, but hurdles to use remain

Bio Pharma Dive

Results from a clinical trial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19

Nurses 293