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Clinical Success Articles & Analysis

143 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.


Biotech Stock News Bite - Longeveron Inc. (NASDAQ: LGVN) Stock Soars on Clinical Pipeline and 2024 Key Priorities and Goals

Biotech Stock News Bite - Longeveron Inc. (NASDAQ: LGVN) Stock Soars on Clinical Pipeline and 2024 Key Priorities and Goals

Investorideas.com (www.investorideas.com) Biotech Stock News Bites - Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines is one of NASDAQ's top gainers today and the stock is trending on Yahoo Finance, currently trading at $3.8955, up $1.6955 or 77.0682%. ...

ByInvestorideas.com


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


Healiva Acquires Two Wound-healing Cell Therapy Assets From Smith+Nephew

Healiva Acquires Two Wound-healing Cell Therapy Assets From Smith+Nephew

The second asset, now named healiva®002, is an off-the-shelf allogeneic cell therapy that has previously demonstrated clinical efficacy in healing VLUs that are resistant to standard treatments. ...

Byhealiva SA


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


Prolonged Analgesia From Bupisome And Bupigel Formulations: From Design And Fabrication To Improved Stability

Prolonged Analgesia From Bupisome And Bupigel Formulations: From Design And Fabrication To Improved Stability

If we are able to demonstrate a successful Phase III clinical trial, we believe Probudur may represent the first long acting local anesthetic with an opioid sparing label. ...

ByVirpax Pharmaceuticals


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.


Bristol-Myers Squibb Awards First “Golden Tickets” for LabCentral to PanTher, Suono Bio

Bristol-Myers Squibb Awards First “Golden Tickets” for LabCentral to PanTher, Suono Bio

We are excited to have them join in the vibrant ecosystem of the LabCentral community and look forward to watching as these companies move down the path toward success.” A pre-clinical-stage company, PanTher Therapeutics is working to revolutionize the treatment of inoperable, locally advanced solid tumors − studying the direct delivery of existing, ...

BySuono Bio


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

“Orgenesis, through its newly formed POCare services subsidiary, has commenced clinical grade production, in collaboration with Hospital Infantil Universitario Niño Jesús in Madrid for the supply of clinical-grade batches of the cell-based product intended for intravenous administration. ...

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

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


Announcement – RSIP Vision Presents Successful Preliminary Results from Clinical Study of 2D-to-3D Knee Bones Reconstruction

Announcement – RSIP Vision Presents Successful Preliminary Results from Clinical Study of 2D-to-3D Knee Bones Reconstruction

RSIP Vision, an experienced developer of groundbreaking AI technologies for medical imaging, today reveals preliminary results from an ongoing clinical study for the evaluation of the reconstruction of a 3D knee model from 2D X-ray images at Assuta Medical Center in Tel Aviv. This tool is based on novel, patent-pending technology, implementing advanced artificial intelligence (AI) to produce an ...

ByRSIP Vision


First Clinically Evidenced Dementia App

First Clinically Evidenced Dementia App

Healthbit’s dementia app is the world’s first clinically evidenced app for patients with mild dementia or mild cognitive impairment (MCI) and their carers.Evidenced through a ground-breaking randomised control trial (RCT), the app has been shown to benefit people living with dementia and their carers in a number of ways. ...

ByHealthbit Ltd


Lumosa One of the Finalists for Clinical Advance of the Year Award in Scrip Awards 2022

Lumosa One of the Finalists for Clinical Advance of the Year Award in Scrip Awards 2022

We are delighted to announce that Lumosa's LT3001 (odatroltide) has been shortlisted for the "Clinical Advance of the Year Award" at this year's Pharma Intelligence Scrip Awards. This Award seeks to recognize success in a clinical trial of a new drug product (biological or chemical) that is expected to lead to an advance in healthcare. ...

ByLumosa Therapeutics Co., Ltd.


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


Microbot Medical Confirms GLP Pre-Clinical Trial is on Track to Commence Later this Month

Microbot Medical Confirms GLP Pre-Clinical Trial is on Track to Commence Later this Month

Food and Drug Administration (FDA) and CE Mark submissions, that it recently shipped multiple LIBERTY Robotic System devices to a market-leading research laboratory to conduct the Company’s GLP pre-clinical trial. The comprehensive trial, which is anticipated to commence later this month, will be performed by a team of global leaders in the endovascular space at a ...

ByMicrobot Medical 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.


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.

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