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Safety Data Articles & Analysis
136 news found
Medical device testing is a crucial step in the development and commercialization of innovative medical devices. To ensure product safety and efficacy, comprehensive testing is required throughout the entire product lifecycle. ...
BySTEMart
“The CE Mark represents a major step forward in enhancing patient care and safety for endovascular therapies in the EU, a market with a higher prevalence of PE when compared to the United States,” said Laura Piccinini, AngioDynamics Senior Vice President/General Manager, Endovascular Therapies and International. ...
APEX-AV is a clinical study aimed at evaluating the safety and efficacy of the Company’s AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in the treatment of acute intermediate-risk pulmonary embolism (PE). ...
These achievements indicate a growing inclination among regulatory bodies to accept data on safety, efficacy, and durability for the endorsement of these treatments. ...
Global phase III QUASAR study will assess the efficacy and safety of aflibercept 8 mg in macular edema secondary to retinal vein occlusion (RVO) Study comes after positive data from the phase III PULSAR trial in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON trial in diabetic macular edema (DME) QUASAR is expected to enroll ...
ByBayer AG
Pharmaceutical testing is a must to ensure that all medications meet the top quality, safety, and performance requirements before they enter the market. CD Formulation’s cGMP-compliant laboratory is well-equipped to identify both the chemical and structural composition of each drug substance. ...
The median PFS was 8.6 months on elacestrant vs 1.9 months for SOC, in those patients whose tumors harbored ESR1 mutations and had been treated with a CDK4/6i for at least 12 months. Safety data is consistent with the other endocrine therapies. Most of the adverse events (AEs), including nausea and musculoskeletal pain were grade 1 and 2. No hematological ...
As of 8 November 2022, 9 patients were enrolled; baseline and safety data for 8 patients were available (n=4 at DL1; n=4 at DL2). 7 patients reached the follow-up period of 28-days and were eligible for efficacy evaluation. ...
(“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, announced preliminary Phase 2 data from the ongoing SMILE trial of onapristone extended release (ONA-XR), the company’s novel, first-in-class, potent, orally administered progesterone receptor (PR) antagonist, ...
For those who were exposed to CDK4/6i ≥12 months prior to randomization on EMERALD, elacestrant achieved: In the all-patient population, a mPFS of 3.8 months on elacestrant vs 1.9 months on SOC, a 39% reduction in the risk of progression or death (HR=0.61 95% CI: 0.45-0.83) In the ESR1-mut population, a mPFS of 8.6 months on elacestrant vs 1.9 months on SOC, a 59% reduction in the risk of ...
Independent Data Monitoring Committee authorized proceeding to Phase 2 at highest dose level tested following review of clinical safety data from the Phase 1 dose escalation Phase 2 clinical data readouts on safety and efficacy of XC001 anticipated in 2022 Company plans to commence study startup of XC001 as ...
These data underscore how managing diabetes can be an overwhelming task that can challenge even the most motivated person living with diabetes,” said Dr. Elizabeth Holt, Head of Global Medical, Clinical, and Safety, LifeScan. “These data suggest the potential benefits of integrating easy to use tools into patients’ day-to-day ...
ByLifeScan
Initiation of the trial is expected in 1Q23. Preliminary data are expected in 4Q23. Third Quarter 2022 and Recent Highlights: Safety data from the ongoing Phase 1 solid tumor trials of narazaciclib in the United States and China continue to be encouraging with the maximum tolerated dose not yet reached in either study. ...
Walid Abi-Saab, Chief Medical officer, at Galapagos said, “We are excited to present data at ACR which highlights our continued commitment to patients and the healthcare provider community, in particular initial data from our first international, real-world arthritis study. ...
” “During the quarter, we presented positive data that support the development programs for the LungFit system using high dose NO as a potential treatment for several indications. At the CHEST Annual Meeting 2022 we presented favorable safety, tolerability, and efficany data for our LungFit GO pilot at-home study of patients with ...
According to the classification of drugs and the characteristics of pharmacological effects, the efficacy and mechanism of drugs are reflected through appropriate in vitro and in vivo models, providing a basis for new drug development and supporting clinical research. Traditionally, toxicity and safety evaluations of drugs are completed utilizing preclinical animal trials. ...
Q3 2022 operational review and recent events Jyseleca commercial & regulatory progress Strong adoption across Europe with reimbursement for rheumatoid arthritis (RA) in 15 countries and for ulcerative colitis (UC) in 10 countries Marketing Authorization Application (MAA) submitted for the treatment of UC to Swissmedic, the regulatory authority in Switzerland Article 20 ...
ContRAst-1 and ContRAst-2 met their primary endpoints of a statistically significant ACR20 (American College of Rheumatology criteria) response versus placebo at week 12 in patients with inadequate response to methotrexate (ContRAst-1) and conventional synthetic or biologic disease modifying antirheumatic drugs (DMARDs) (ContRAst-2). Data from ContRAst-3, the third trial in the ...
The results of this trial, including the initial results of a Double-Blind Placebo Controlled Oral Food Challenge (DBPCOFC), will provide long-term safety data and inform the starting dose while further defining the clinical profile of INT301. ...
Initial topline data from the study were included in a presentation at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022) on April 25, 2022. ...