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Successful Clinical Articles & Analysis

74 news found

Huateng Pharma's mPEG-pALD Receives FDA DMF Filing Approval

Huateng Pharma's mPEG-pALD Receives FDA DMF Filing Approval

This achievement highlights Huateng Pharma’s dedication to meeting the highest regulatory standards and further strengthens its commitment to supporting the pharmaceutical industry’s research and clinical needs. The successful DMF filing demonstrates that Huateng Pharma’s production processes and quality control systems fully comply with FDA ...

ByHunan Huateng Pharmaceutical Co. Ltd.


Harmony Nominated for Industry Partner of the Year Award

Harmony Nominated for Industry Partner of the Year Award

Each year, the Southeast Service Cooperative in Minnesota presents its Outstanding Industry Partner of the Year Awards, celebrating southeast Minnesota partners who build youth skillsets and mindsets through real-world, hands-on, career-connected learning experiences that serve as a ladder to prosperity. ...

ByHarmony Enterprises, Inc.


LC-MS/MS Data Analysis Now Available Utilizing CD Genomics’ Bioinformatics-Analysis Solution

LC-MS/MS Data Analysis Now Available Utilizing CD Genomics’ Bioinformatics-Analysis Solution

Mass spectrometry is a powerful analytical tool that plays a key role in drug development by providing accurate, reliable, and timely data for successful clinical trials, disease research, drug development, and target discovery experiments. ...

ByCD Genomics


How Great Clinical Trial Managers Stand Out From The Rest

How Great Clinical Trial Managers Stand Out From The Rest

Clinical Trial Manager roles are growing 32% faster than the national average. ...

ByBrio Group


Biomark announces update from oongoing clinical trial using its lung cancer liquid biopsy test as it prepares for commercial launch

Biomark announces update from oongoing clinical trial using its lung cancer liquid biopsy test as it prepares for commercial launch

As clinical trial success relies on effective patient recruitment, BioMark is delighted to announced today that enrollment for its pivotal lung cancer screening study exceeded 1000 participants in less than one year. ...

ByBioMark Diagnostics Inc.


MorphoSys Presents New Longer-term Phase 2 Results on Pelabresib in Myelofibrosis, Including Potential Disease-Modifying Activity, at ASH 2022

MorphoSys Presents New Longer-term Phase 2 Results on Pelabresib in Myelofibrosis, Including Potential Disease-Modifying Activity, at ASH 2022

In the MANIFEST study, changes in biomarkers correlated with improvements in clinical measures of treatment success (SVR35, TSS50 and hemoglobin increases indicative of improved anemia), suggesting a potential disease-modifying effect of pelabresib. ...

ByMorphoSys AG


XF-73 Nasal Phase 3 development plans finalised

XF-73 Nasal Phase 3 development plans finalised

This Phase 3 programme is expected to include up to 2,000 patients and deliver a comprehensive data set supporting a clinical endpoint in Surgical Site Infection (“SSI”) reduction that is clinically and statistically significant. Successful clinical studies will therefore provide Destiny Pharma with a broad surgery ...

ByDestiny Pharma plc


VeriSIM Life Named “Predictive Analytics Solution of the Year” by BioTech Breakthrough

VeriSIM Life Named “Predictive Analytics Solution of the Year” by BioTech Breakthrough

Technologies like our unique Translational Index™, which synthesizes the potential for clinical success of any drug candidate, enable smarter decisions about how to advance drug asset programs and ultimately improve the lives of patients in ...

ByVeriSIM Life


CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema

CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema

Successfully converted patients who received Zephyr Valves had clinically meaningful Target Lobe Volume Reduction (TLVR) with a mean reduction of greater than one (1) liter. The CONVERT trial is ongoing and full clinical outcomes of BLVR with Zephyr Valves were not reported at this time. However, results recently published from a single-center feasibility study ...

ByPulmonx Corporation


Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis

Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis

The resulting constructs reduce spinal flexibility and magnify the forces experienced by adjacent levels, often leading to accelerated degeneration of the adjacent spinal segments. While the acute clinical outcomes may be excellent, this accelerated degeneration can lead to longer term issues, sometimes requiring additional surgery. ...

ByEmpirical Spine, Inc.


Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis

Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis

William Welch, MD of the University of Pennsylvania and co-principal investigator of the LimiFlexIDE study added, "I am encouraged by the clinical outcomes and results we have seen so far in the study. LimiFlex is an exciting new possibility for patients currently undergoing fusion for degenerative spondylolisthesis and would offer much faster recovery for patients, significant ...

ByEmpirical Spine, Inc.


Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis

Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis

The resulting constructs reduce spinal flexibility and magnify the forces experienced by adjacent levels, often leading to accelerated degeneration of the adjacent spinal segments. While the acute clinical outcomes may be excellent, this accelerated degeneration can lead to longer term issues, sometimes requiring additional surgery. ...

ByEmpirical Spine, Inc.


enVVeno Medical Appoints Kevin Belteau as Vice President of Clinical Operations

enVVeno Medical Appoints Kevin Belteau as Vice President of Clinical Operations

Belteau joined Medtronic as a field engineer upon graduation from college and has progressed through various clinical operations roles over the course of his tenure there. Most recently he managed his own team of clinical operations professionals and has been directly involved is more than 75 clinical studies for class III medical devices seeking ...

ByenVVeno Medical


Synchron Appoints Kurt Haggstrom as Chief Commercial Officer

Synchron Appoints Kurt Haggstrom as Chief Commercial Officer

Kurt will bring world-class commercial leadership to ensure we have designed the product and clinical trials in readiness for launch of the first commercial implantable BCI into the U.S. market,” said Tom Oxley, CEO, Synchron. “Kurt joins us at a crucial moment in our development, on the heels of successful clinical results in our ...

BySynchron, Inc.


SafeHeal appoints medical device industry veteran Chris Richardson as Chief Executive Officer

SafeHeal appoints medical device industry veteran Chris Richardson as Chief Executive Officer

He has served as Chairman of the Board of Directors at Neurolief, creator of a digital therapeutics platform based on a clinically-validated neuromodulation technology to treat chronic neurological and neuropsychiatric disorders such as migraine and depression. ...

BySafeHeal


Kurve Therapeutics Announces Next-Gen Technology Designed for a New Approach to Treating CNS Disorders

Kurve Therapeutics Announces Next-Gen Technology Designed for a New Approach to Treating CNS Disorders

Led by a team of experienced entrepreneurs with successful track records in biotech, pharmaceuticals, neuroscience, and device technology, Kurve Therapeutics is paving the way for revolutionary clinical success in treating complex CNS disorders including Alzheimer’s disease, cognitive aging, Lewy body dementia, and Parkinson’s ...

ByKurve Therapeutics, Inc.


EsoCap holds a multidisciplinary advisory board meeting on Barrett’s esophagus

EsoCap holds a multidisciplinary advisory board meeting on Barrett’s esophagus

EsoCap AG organized a multidisciplinary scientific advisory board meeting with eight international experts in Barrett’s esophagus (BE) in Zurich EsoCap’s technology for the topical treatment of Barrett’s esophagus was recognized by the experts for having high potential for clinical success EsoCap’s proprietary and unique targeted ...

ByEsoCap AG


Robocath achieves positive results in R-Evolution multicenter European clinical study on robotic coronary angioplasty

Robocath achieves positive results in R-Evolution multicenter European clinical study on robotic coronary angioplasty

100% clinical success rate: zero complications linked to robot up to 30 days post-procedure >95% technical success rate 84.5% average reduction in physician radiation exposure Robocath, a company that designs, develops and commercializes innovative robotic platforms for the treatment of vascular diseases, today presents the results of ...

ByRobocath


ImmunogenX Highlighted at Pre-Eminent Celiac Disease Conference

ImmunogenX Highlighted at Pre-Eminent Celiac Disease Conference

On the basis of clinical success and acknowledged leadership in the field of celiac disease, the organizers of the International Celiac Disease Symposium (ICDS) have invited Jack Syage PhD, CEO of ImmunogenX, to deliver a panel talk and join the Conference Faculty. ...

ByImmunogenX, Inc.


Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery

Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery

Longer term follow-up to evaluate the maintenance of clinical outcomes is in process. “This study is a valuable addition to our clinical evidence base,” said Glen Kashuba, chief executive officer of Cerapedics. “This is now our fourth prospective clinical study in which i-FACTOR Bone Graft has demonstrated a clear ...

ByCerapedics, Inc.

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