clinical safety News
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NYMOX Receives RTF letter from FDA
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) Nymox reports today that it has received a Refusal to File (“RTF”) letter from FDA on Friday May 20th at 2:48 pm EST, with regard to the Company's New Drug Application (“NDA”) for Fexapotide Triflutate. Nymox’s position is that clarifications remain to be resolved at a follow-up meeting and that some significant ...
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Balt Completes Enrollment in FIRST: A Multi-center, Prospective, International Study of Low Profile Silk Vista Flow Diverters
Balt, an innovative neurovascular company focused on developing, designing, and manufacturing solutions for treating complex, life-threatening conditions, including stroke, aneurysms, and arteriovenous malformations, today announced enrollment in the FIRST study has been completed. The FIRST study is an observational, prospective, multi-center, international, single-arm study with the aim of ...
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Flat Medical announced FDA 510(k) clearance of EpiFaith, the Epidural Safety Solution
Flat Medical Co., Ltd., the medtech company specializing in clinical safety solutions, announced it received 510(k) clearance from the U.S. Food and Drug Administration for its EpiFaith® syringe to deliver safe epidural locating solution. Based on the LOR technique, the EpiFaith® syringe is a physician-centered safeguard for epidural analgesia, which is indicated for painless labor, ...
By Flat Medical
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Webinar #4: The CAM Assay: From Efficacy/Toxicity Studies to Mechanisms of Action Analysis
Webinar Description: Understanding the mechanisms of action of new drugs is a key success factor for efficient drug discovery. It’s necessary for: Anticipating problems relating to clinical safety Determining the site of interaction between a drug and a receptor Identifying which patients will respond to a given treatment Improving drug dosing Considering combinations or ...
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CUTISS receives Positive Opinion from the Paediatric Committee of the EMA for denovoSkin™
CUTISS AG, an innovative Swiss Life Science Company aiming to provide patients that suffer from large and deep skin defects with an automatically produced, personalized skin tissue therapy, denovoSkin™, today announced that it received a positive opinion from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) for its proposed Paediatric Investigation Plan (PIP) for ...
By CUTISS AG
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Lipella Pharma Sees Positive Results for LP-10 Phase 2a Trial
Lipella Pharmaceuticals Inc. said it saw positive top-line results from its recently completed Phase 2a clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for hemorrhagic cystitis. The biotechnology company said its next step will be to communicate with the Food and Drug Administration on the study’s results and the pathway forward to seeking regulatory approval ...
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Chrysalis BioTherapeutics Receives $10.4 Million From BARDA to Continue Development of TP508 as a Nuclear Countermeasure
Chrysalis BioTherapeutics, Inc., a clinical-stage biotechnology company focused on the development of regenerative medicines to save lives, announced today that the Biomedical Advanced Research and Development Authority (BARDA) part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services executed options to add $10.4 ...
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ASTM F2743 - 11 standard guide for coating inspection and acute particulate characterization of coated drug-eluting vascular stent systems
The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides guidance for coating inspection and acute particulate characterization of drug eluting ...
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Update regarding our Amyotrophic Lateral Sclerosis (ALS) study conducted at Sahlgrenska University Hospital in Gothenburg, Sweden
Our Phase IIa clinical trial evaluating the safety, tolerability and possible efficacy of subcutaneous injections of ILB® in ALS is finalized and has been reported to the Swedish Medical Products Agency. The results indicate that, for the variants of ALS and the given dose investigated in the study, ILB® seems to have beneficial clinical effects without significant side effects. A ...
By TIKOMED AB
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Servier and Poietis announce scientific partnership in 4D bioprinting of liver tissues
Servier, an independent international pharmaceutical company, and Poietis, a leader in the production of living bioprinted tissues, have announced a scientific partnership to use Poietis’s 4D bioprinting technology for the development and production of liver tissues. This partnership seeks to improve the detection of drug-induced liver lesions as early as the preclinical trial phase. ...
By Poietis
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Artugen Therapeutics Announces First Patient Dosed with ART24, Artugen`s first clinical product candidate for prevention of recurrence of Clostridium difficile infection
ART24 granted Fast Track Designation First Patient Dosed Concord, Mass., and Dublin, Ireland March 12, 2020 — Artugen Therapeutics Limited, a Company developing novel live biotherapeutics (LBPs) for patients living with infectious, inflammatory and oncologic diseases announced today the first patient dosed with ART24, the Company’s first clinical product candidate for prevention ...
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Gesynta Pharma prepares Phase II study of GS-248 in endometriosis following ground-breaking data from a preclinical proof-of-concept study
Gesynta Pharma AB today announces the decision to advance the development of its clinical-stage drug candidate GS-248 in endometriosis - a chronic inflammatory condition affecting approximately 10 percent of all women of reproductive age. This strategically important decision follows a recent preclinical proof-of-concept study with GS-248 in an advanced model of endometriosis, where ...
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Clinical Trial Phase I “Safety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal Subjects” completed.
tiakis Biotech AG (formerly Proteo Biotech AG) has attained another milestone in its Pulmonary Arterial Hypertension (PAH) development program by receiving the final clinical phase 1 trial report demonstrating the very good safety profile of Tiprelestat (no severe adverse occurred). tiakis’s research partners and investigators at Stanford University School of Medicine, Dr. Marlene ...
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StemBioSys participates in Biotech Showcase Digital during J.P. Morgan Week 2021
StemBioSys, Inc., a privately held biomedical company that manufactures and develops innovative, advanced human stem cell technologies to improve the predictive power of pre-clinical drug safety screening, today announced its President and Chief Executive Officer Bob Hutchens will participate in Biotech Showcase Digital being held January 11-15, 2021. During Biotech ...
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ClearPoint Neuro Congratulates Neurona Therapeutics on IND Clearance for Neural Cell Therapy NRTX-1001 in Chronic Focal Epilepsy Patients
ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today congratulates partner Neurona Therapeutics on clearance by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application to initiate its first-in-human Phase 1/2 clinical trial evaluating the safety and ...
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Aerami Therapeutics to Present at the LifeSci Partners Summer Symposium
Aerami Therapeutics, Inc. (the “Company”) announced today that Anne Whitaker, Chief Executive Officer, will present a corporate overview at the Private Healthcare Company Virtual Summer Symposium, hosted by LifeSci Partners, on August 4 and 5, 2020. Please click the following link to register Presentation Details: Date: August 5, 2020 Time: 9:00 am Eastern Time About Aerami ...
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Harris Health System selects DNV Healthcare for Hospital Accreditation
Harris Health System will pursue accreditation from DNV Healthcare for its three hospitals. Harris Health System will pursue accreditation from DNV Healthcare for its three hospitals. DNV’s unique program integrates ISO 9001 compliance with the Medicare Conditions of Participation. Harris becomes the third major hospital system in the Texas Medical Center switching to DNV, joining The ...
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NeoTherma Oncology Announces FDA IDE Submission to Permit Investigational Treatment of Pancreatic Cancer Patients with Its FDA-Designated Breakthrough Device, the VectRx Thermal Oncology System
NeoTherma Oncology, (NTO) a privately held medical device company developing novel non-invasive treatments for solid tumors, today announces they have submitted an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) to initiate First-in-Human (FiH) studies of the VectRx™ System in patients with pancreatic cancer being treated with standard of care ...
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Reva Medical Presents 6-Month Results from Motiv BTK Pilot Study
REVA Medical, LLC. (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, is pleased to announce the presentation of the 6- month clinical outcomes data from a post market study of the Company’s MOTIV Below The Knee (BTK) scaffold. Prof. Thomas Rand, MD from the Klinik Floridsdorf Vienna, Austria presented the initial ...
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XF-73 Dermal infection project advances into clinically enabling safety study with US Government’s NIAID
Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, is pleased to announce the commencement of an Investigational New Drug (IND) enabling safety study with its novel XF-73 Dermal formulation. This study is the second of two planned preclinical safety studies of the XF-73 ...
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