Outlook Therapeutics stock craters as wet AMD drug fails Phase III …
2024年11月27日 · Outlook Therapeutics’ second attempt to obtain US approval for its wet age-related macular degeneration (wet AMD) therapy, Lytenava (bevacizumab-vikg) has suffered a setback as the therapy failed to meet a key endpoint in Phase III NORSE EIGHT trial.. Although the NORSE EIGHT study (NCT06190093) did not meet the pre-specified non-inferiority …
Cassava Sciences stock plummets after Phase III Alzheimer’s fail
2024年11月25日 · Cassava Sciences’ stock has dropped by more than 80% after the company revealed its lead and only investigational product simufilam did not meet the primary endpoints in a Phase III Alzheimer’s disease trial.. The Phase III ReThink-ALZ study (NCT04994483) of simufilam in mild-to-moderate Alzheimer’s disease did not meet each of the pre-specified co …
MHRA expects new UK clinical trial regulation implementation by …
2024年10月16日 · Between 2022 and 2023, the MHRA undertook a consultation period surrounding a new legislative framework for clinical trials in the UK. The MHRA said the new regulation will ensure patients and their safety are the focus of all clinical trials, while bringing the benefits of clinical trials to everyone.
AHA 2024: Zerlasiran shows promising Phase II results for elevated ...
2024年11月19日 · Dr. Steven Nissen, MD chairman and chief academic officer of the Heart and Vascular Institute at the Cleveland Clinic and professor of medicine at the Lerner College of Medicine, reported that subcutaneous injections of 300mg or 450mg of zerlasiran, administered every 16 or 24 weeks, reduced time-averaged Lp(a) levels by 80% to 85% over a follow-up …
Cassava Sciences: Phase III trials storm ahead amid controversy
2024年10月9日 · In a related order, the SEC also charged Cassava consultant, Dr. Hoau-Yan Wang, an associate medical professor at the City University of New York’s (CUNY) Medical School and the therapeutic’s co-developer, for manipulating the reported clinical trial results.
Pfizer reports data from prostate cancer combination therapy trial
2024年10月11日 · Participants were divided into two cohorts: an all-comers group and those with homologous recombination repair (HRR) gene mutations. Radiographic progression-free survival (rPFS) was the trial’s primary endpoint while secondary endpoints comprised OS, objective response rate (ORR), duration of response (DOR) and prostate-specific antigen (PSA) response.
Clinical Trials Arena Excellence Awards 2024: IQVIA
The pharmaceutical industry is witnessing a transformative era where technology is reshaping the landscape of clinical trials. IQVIA has been at the forefront of this revolution with its groundbreaking Supply Automation Value Engine (SAVE). The tool has garnered the company an excellence award in the Innovation category in the 2024 Clinical Trials Excellence Awards.
AbbVie’s acquired Parkinson’s disease drug shines in Phase III trial
2024年9月27日 · AbbVie’s recently acquired Parkinson’s disease candidate tavapadon significantly reduced the burden of disease in a Phase III trial.. The Phase III TEMPO-1 trial (NCT04201093) evaluated two daily doses of tavapadon (5mg and 15mg). The trial met its primary endpoint, with both dose groups outperforming placebo in improving disease burden …
GSK reports positive findings from Phase III RSV vaccine trial
2024年10月9日 · Following the initial season, 12,469 individuals from the vaccine group were re-randomised to receive either the RSV vaccine or a placebo. The study then measured the vaccine’s efficacy over the subsequent two RSV seasons, with the results indicating a cumulative efficacy of 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD.
MSD reports outcomes from Phase III trial of pembrolizumab
2024年11月20日 · MSD has reported positive topline outcomes from the Phase III MK-3475A-D77 study assessing the noninferiority of subcutaneous Keytruda (pembrolizumab) administration, in conjunction with chemotherapy, for the first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC).. Pembrolizumab is available for intravenous use as Keytruda.