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Safety Monitoring Articles & Analysis
47 news found
Fresh air helps to push out virus-filled air from a room, reducing the risk of COVID-19 as long as other safety measures like masking and social distancing are followed. Putting the importance of ventilation into perspective. ...
ByZeptive
Efficient leadership plays a huge role in bringing a clinical trial to fruition. Pharmaceutical companies are not immune to making mistakes and facing failures. Lack of funding, safety issues, and patient dropouts are some of the struggles clinical development teams face. Some problems you as a leader may face may not always be in your control, e.g., lack of funding. Other ...
-The STAMINA-001 study will evaluate ATG-037 as a monotherapy and in combination with the immune checkpoint inhibitor (ICI), pembrolizumab, to determine the safety, pharmacology, and preliminary efficacy in patients with locally advanced or metastatic solid tumors. ...
New results from the Phase III ARASENS trial evaluating quality of life (QoL) and patient-relevant endpoints for darolutamide plus androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) show that, in addition to extending overall survival (OS), darolutamide has a strong tolerability profile and ability to maintain patient QoL with ...
ByBayer AG
Long-term follow-up is on-going in order to obtain additional safety and efficacy outcome measures. “Currently available BPH medications are often insufficiently effective or involve side effects, including but not limited to sexual dysfunction and compromised quality of life, which result in 66% of patients discontinuing medication within 1 year. ...
Darolutamide now has indications in both non-metastatic castration-resistant prostate cancer (nmCRPC) for men at high risk of developing metastatic disease and metastatic hormone-sensitive prostate cancer (mHSPC) Today’s approval under the FDA’s Real-Time Oncology Review (RTOR) pilot program was based on the pivotal Phase III ARASENS trial, which showed a significant overall ...
ByBayer AG
Beacon Biosignals' platform provides an architectural foundation for discovery of robust quantitative neurobiomarkers that subsequently can be deployed for patient stratification or automated safety or efficacy monitoring in clinical trials. The powerful and validated algorithms developed by Beacon's machine learning teams can replicate the consensus ...
This maintenance period allows for the evaluation of safety after long term use of INT301. Additionally, the amendment allows for the inclusion of a Double-Blind Placebo Controlled Oral Food Challenge (DBPCOFC) at the end of treatment. ...
At the completion of year two, the safety of the vaccine was assessed by an independent Data Safety Monitoring Board (DSMB), chaired by Dr. ...
ByCalviri
Milan, Italy (June 1st, 2022) – Today, KLISBio, a MedTech company challenging the status quo in regenerative medicine by leveraging a silk-based multidisciplinary technology platform, announced its attendance to 2022 IFSSH, IFSHT & FESSH Combined Congress organized by the International Federation of Societies for Surgery of the Hand and International Federation of Societies for Hand ...
ByKLISBio
A new study with TikoMed’s platform lead clinical drug candidate ILB®, provides positive safety and tolerability results and the first clinical evidence of encouraging clinical efficacy of ILB® in the treatment of Amyotrophic Lateral Sclerosis (ALS). The study was published in PLOS ONE today. In a phase II study of ILB administered to patients with ALS for five weeks, the ...
Stratus offers a wide variety of EEG services, including monitored long-term video studies and routine EEGs conducted in the hospital, clinic, and in patients' homes. ...
” “In tandem, we are excited about our earlier stage pipeline and continue to enroll our Phase 1b clinical study of SER-155 designed to evaluate safety, microbiome alterations, and the impact on infections and/or graft versus host disease (GvHD) in adult subjects who are undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). ...
Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The application is being conducted under the FDA Oncology Center of ...
ByBayer AG
Reporting of primary endpoint on track for Q4 2022 FDA regulatory submission on track for mid-2023 70% survival of POSEIDON Roll-In patients at one year post-implantation1 compares favourably to published literature in this high-risk patient population Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical”), an innovator in the treatment ...
Based on pre-specified criteria, including the safety profile of patients enrolled in Cohort 1 and Cohort 2, the internal Safety Monitoring Committee approved the opening of Cohort 3, starting patients at Dose 3, and potentially reducing the up-titration phase of INT301 by four weeks and two office visits. ...
SNG001 was included in this study in February 2021 and the Independent Data Safety Monitoring Board for ACTIV-2 had previously (October 2021) recommended it advance from Phase 2 into Phase 3. ...
One-Year Final Data Highlights Lead Cell Therapy Asset, CAP-1002, for Safety and Efficacy in Slowing Upper Limb and Cardiac Function Deterioration in Patients Data Sets Stage for Pivotal Phase 3 HOPE-3 Clinical Trial Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the ...
The primary objective of the trial was to evaluate the safety and tolerability of TSC administered on a more frequent dosing regimen not previously tested in a clinical trial setting. ...
ByCervoMed
[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the ongoing Phase III pivotal CardiAMP™ Cell Therapy Heart Failure Trial (ClinicalTrials.gov Identifier: ...