Biomea’s stock bounces back as FDA lifts clinical hold on diabetes …
Sep 27, 2024 · Biomea Fusion’s stock is on the up after the company plans to resume two clinical trials evaluating its type 1 and 2 diabetes therapy after the US Food and Drug Administration (FDA) lifted a full clinical hold. In June, the US regulatory agency paused the trials of BMF-219 after reports of potential drug-induced hepatotoxicity emerged.
Scholar Rock stocks skyrocket after SMA drug scores at Phase III
Oct 8, 2024 · The Phase III SAPPHIRE trial (NCT05156320) evaluating Scholar Rock’s lead pipeline candidate apitegromab, met its primary endpoint of statistically significant and clinically meaningful improvement in motor function, as measured by the Hammersmith Functional Motor Scale Expanded (HFMSE). The company’s stock price rocketed by 362% after the ...
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Disc Medicine secures $200m financing to support trials. The loan facility comprises up to four tranches, with a $30m tranche already drawn at closing and further funds available through H2 2026.
Pfizer reports data from prostate cancer combination therapy trial
Oct 11, 2024 · In the trial, a TALZENNA plus XTANDI combination regimen offered overall survival (OS) improvement in metastatic castration-resistant prostate cancer (mCRPC) patients. October 11, 2024. The trial involved 1,035 mCRPC patients across the US, Canada, Europe, South America and Asia-Pacific. Credit: NMK-Studio/Shutterstock.
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. October 8, 2024. Despite the outcome of the SunRISe-2 trial, Johnson & Johnson has seen potential in TAR-200 in the SunRISe-4 study for MIBC.
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 ...
Hepatitis B: Four trials to watch over the next 12 months
Jul 28, 2023 · Hepatitis B immune globulin (Hepatect, Nabi-HB, Zutectra, Neohepatect, Fovepta) contains mainly immunoglobulin G and acts as passive immunising preparation. The two cohorts are HBsAg positive and HBeAg negative, with one group having had no treatment while the other group will have been treated with anti-HBV NUC for at least 12 months before ...
A schizophrenia win for BMS’ Cobenfy, but challenges lie ahead
Oct 1, 2024 · BMS has proposed an annual cost of therapy (ACOT) of $22,500 for Cobenfy. This is a significant premium compared to generic oral aripiprazole, which has an average ACOT of $540. It is likely that payers will require failure on at least one cheaper atypical antipsychotic before Cobenfy is reimbursed. Furthermore, Cobenfy requires twice-daily ...
Contract Research Organizations for the Clinical Trials Industry
Within the healthcare industry, CROs offer a range of services for various stages of product development, clinical trial, review and marketing. Some of the current industry leading services include, without necessarily being limited to: Formulation expertise in the research and development stage. Preclinical and clinical studies stage: site ...
Obesity: Six trials to watch over the next 12 months
Jun 30, 2023 · According to a report by GlobalData, the market for obesity drugs is predicted to be worth $37.1bn in 2031. GlobalData is a parent company of the Clinical Trials Arena. As more trials take place globally, not only will this help to provide a wider range of treatments for patients but will also assist the unmet need of lack of supply.