Biomea’s stock bounces back as FDA lifts clinical hold on diabetes …
Sep 27, 2024 · Biomea’s CEO, Thomas Butler noted that the FDA lifted the clinical hold based on a “safety review of the ongoing Phase IIb expansion study, where the concerning safety signals seen in the Phase IIa escalation study did not translate over to the larger expansion study”.
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Longboard commences Phase III trial of bexicaserin for DEEs seizure treatment. In the trial, participants will undergo a five-week screening period, followed by baseline evaluations.
Pfizer reports data from prostate cancer combination therapy trial
Oct 11, 2024 · 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.
Navigating the confluence of AI and community-based trials: Is …
Oct 2, 2024 · Current diversity challenges in clinical trials. According to data collated by analytics firm GlobalData, recruitment of participants for clinical trials remains a critical challenge, with around 80% of global studies failing to recruit and retain enough participants to enroll on time.The challenge is particularly severe in diverse populations, and the latest FDA report highlights the ...
Johnson & Johnson cancels Phase III trial of bladder cancer drug
Oct 8, 2024 · Johnson & Johnson discontinues Phase III study of treatment for bladder cancer. The company's TAR-200 drug candidate did not show superiority to chemoradiation in the SunRISe-2 study.
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Obesity: Six trials to watch over the next 12 months
Jun 30, 2023 · With an estimated market value of $37.1bn in 2031, the race for the development of obesity medications is on. Here are some trials to watch.
Hepatitis B: Four trials to watch over the next 12 months
Jul 28, 2023 · While Dr Antonio Bertoletti, professor at the Duke-NUS Medical School in Singapore and an infectious disease doctor who has been working on Hepatitis B trials for 30 years, said he thinks that it is more important for trials in Hepatitis B to find patient populations in which they may be most effective rather than seek a one-size fits all treatment.
Biosimilars: top 10 pharma companies leading the way
2021 was a record-breaking year, with more businesses breaking into the billion-dollar club. Many start-ups have achieved or retained the unicorn status by the end of the year to reflect nearly a fivefold growth from that in 2020.
Alzheimer's trials: How does donanemab compare to lecanemab?
Jan 13, 2023 · Already, 2023 is shaping up to be an eventful year in Alzheimer’s disease (AD) drug development. After the FDA’s approval of Eisai/Biogen’s Leqembi (lecanemab) on January 6, the AD field is now looking toward the upcoming approval decision for Lilly’s donanemab expected in May. Although both donanemab and lecanemab have similar therapeutic targets, the two AD antibodies employed ...