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Clinical Trial For Success Articles & Analysis

82 news found

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

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

Changsha, China – Hunan Huateng Pharmaceutical Co., Ltd. (Huateng Pharma), a global leader in the development and production of high-quality PEG derivatives, is pleased to announce that its mPEG-pALD (20K) has successfully completed its Drug Master File (DMF) filing with the U.S. Food and Drug Administration (FDA), under DMF No. 040600. This achievement highlights Huateng Pharma’s ...

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

(“BioMark” or the “Company”) (CSE: BUX) (FSE: 20B) (OTCMKTS: BMKDF) an advanced stage liquid biopsy company with a focus on hard to detect and treat cancers is pleased to announce several updates from ongoing clinical trial using the Company’s liquid biopsy test for early cancer detection and monitoring of lung cancer. As ...

ByBioMark Diagnostics Inc.


Combines mesenchymal stem-cell-based product, with Kurve’s intranasal drug delivery technology

Combines mesenchymal stem-cell-based product, with Kurve’s intranasal drug delivery technology

Changing the administration route of a cell-based therapy, as with any drug product, requires rigorous testing and is considered a different therapy requiring a set of pre-clinical and clinical testing according to applicable regulatory guidelines. ...

ByKurve Therapeutics, 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

The aim of the announced Phase 3 clinical programme is to deliver comprehensive clinical trial data demonstrating that nasal decolonisation using XF-73 Nasal, alongside “standard of care”, reduces the incidence of post-surgical infections in patients. ...

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

VeriSIM Life (VeriSIM) www.verisimlife.com, the leading artificial intelligence (AI)-enabled, unique R&D decisions de-risker for breakthrough drug development, today announced it has been selected as the winner of the “Predictive Analytics Solution of the Year" in the BioTech Breakthrough Awards program conducted by BioTech Breakthrough. Biotech Breakthrough is a leading independent ...

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 ...

ByPulmonx Corporation


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

The trial previously exceeded its target of 135 LimiFlex patients enrolled into the investigational arm and 160 patients enrolled into the control arm of the trial. ...

ByEmpirical Spine, Inc.


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 trial has reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial; the control arm will continue enrolling subjects to its target of 160 patients. ...

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 trial reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial in December 2019 and the control arm has achieved its target of 160 patients. ...

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

“Our expectation is to be engaged in multiple clinical trials over the next several years in order to support the worldwide adoption of our products,” said Robert Berman, enVVeno Medical’s Chief Executive Officer. “We will look to Kevin to immediately contribute to our existing clinical activities and to build a ...

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 ...

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

PARIS, France/Tampa, FL – July, 11, 2022 – SafeHeal™, a leading innovator in the field of digestive surgery and developer of the Colovac device, announced today the appointment of Chris Richardson as Chief Executive Officer (CEO), who assumes responsibilities immediately. Richardson has over 30 years of experience in the medical device industry, and an extensive ...

BySafeHeal


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


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.


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. ...

ByEntero Therapeutics, Inc.

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