Clinical Investigator Inspection List (CLIIL)
The Clinical Investigator Inspection List contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 23, 2017 Category: Drugs & Pharmacology Source Type: news
FDA grants IND clearance for Servier ’s UCART19 to treat relapsed / refractory ALL
The US Food and Drug Administration (FDA) has granted an investigational new drug (IND) clearance to Servier to proceed with the clinical development of UCART19 in the country. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - March 13, 2017 Category: Pharmaceuticals Source Type: news
Glenmark wins FDA nod for Phase II study of nebulized tiotropium bromide
Glenmark Pharmaceuticals said today that the FDA approved its Investigational New Drug application for a Phase II study of its nebulized tiotropium bromide.
The Mahwah, N.J.-based company plans to enroll 155 patients with mild to moderate chronic obstructive pulmonary disease and evaluate its GSP 304 formulation as a daily maintenance treatment for bronchospasm.
Get the full story at our sister site, Drug Delivery Business News.
The post Glenmark wins FDA nod for Phase II study of nebulized tiotropium bromide appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Food & Drug Administration (FDA) Respiratory Wall Street Beat Glenmark Pharmaceuticals Source Type: news
Celyad obtains FDA approval to initiate the NKR-2 CAR T cells THINK trial in the USA
IND (Investigational New Drug) approval triggers the initiation of the THINK trial in the U.S.
Rosewell Park (NY) and University of Pittsburgh Medical Center UPMC (PA) approved and ready to enroll patients.
No toxic event in the other patients enro... Biopharmaceuticals, Oncology, FDA Celyad, NKR-T (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 8, 2017 Category: Pharmaceuticals Source Type: news
FDA asks Titan for more info before clinical trial of ropinirole implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA put a hold on the clinical trial of its ropinirole implant and told the company to submit more information to the federal watchdog.
After it completed an initial review of the implant’s Investigational New Drug application, the FDA asked Titan for final release test data on its ropinirole implant and the applicator used to insert the implant. Titan also needs to identify a principal investigator for the study, although the company said it is in the process of qualifying the participating clinical sites.
Get the full story at our sister site, Drug Delivery Bu...
Source: Mass Device - February 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Implants Neurological Wall Street Beat Titan Pharmaceuticals Source Type: news
Renova takes over rights to heart failure candidate stresscopin from Janssen
US-based Renova Therapeutics has signed an agreement to receive the investigational new drug (IND) file for stresscopin from Janssen Pharmaceuticals. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - February 8, 2017 Category: Pharmaceuticals Source Type: news
Aura Biosciences wins FDA nod for light-activated ocular melanoma treatment
Aura Biosciences said today that the FDA approved its Investigational New Drug Application for the company’s light-activated viral nanoparticle conjugates for the treatment of ocular melanoma.
The federal watchdog’s approval allows Cambridge, Mass.-based Aura to move forward with initial clinical tests of AU-011. The Phase Ib open-label clinical trial, which is currently enrolling, is designed to evaluate the safety, immunogenicity and preliminary efficacy of 2 dose levels of AU-011 for the treatment of small-to-medium primary ocular melanoma, according to Aura.
Get the full story at our sister site, Drug Del...
Source: Mass Device - February 6, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Oncology Optical/Ophthalmic Regulatory/Clearance Wall Street Beat Aura Biosciences Source Type: news
Realm Therapeutics submits IND for PR022 to FDA for atopic dermatitis
US-based biopharmaceutical company Realm Therapeutics has submitted its first investigational new drug (IND) application for PR022 to the US Food and Drug Administration (FDA) for the treatment of patients affected with atopic dermatitis (AD). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - January 31, 2017 Category: Pharmaceuticals Source Type: news
NantKwest launches clinical trial for natural killer cells
NantKwest Inc. (NSDQ:NK) said yesterday that the FDA approved an Investigational New Drug Application for its natural killer cell therapy phase I clinical study. The company is evaluating its genetically engineered, allogenic natural killer cell therapy in patients with cancer.
The study, which NantKwest touts as the 1st of its kind, will determine the safety of natural killer cell monotherapy given intravenously once a week in as many as 16 patients with metastatic or locally advanced solid tumors.
Get the full story at our sister site, Drug Delivery Business News.
The post NantKwest launches clinical trial for natural k...
Source: Mass Device - January 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Food & Drug Administration (FDA) Oncology Wall Street Beat NantKwest Source Type: news
Deals this week: Takeda Pharmaceutical, HUYA Bioscience International, Egalet
Japanese pharmaceutical company Takeda Pharmaceutical has signed a global agreement with US-based bio-pharmaceutical company Ovid Therapeutics for clinical development and commercialisation of the former ’s investigational new drug TAK-935. (Source: Drug Development Technology)
Source: Drug Development Technology - January 20, 2017 Category: Pharmaceuticals Source Type: news
Keystone Nano wins FDA nod for nanoliposome cancer treatment
Keystone Nano said today that the FDA approved its investigational new drug application for the ceramide nanoliposome as a treatment for solid tumors. The company will launch a phase I trial at 3 sites to evaluate safe dosing levels and the product’s efficacy as a cancer therapy.
Ceramide is a lipid that has demonstrated efficacy in liver cancer, breast cancer, leukemia and pancreatic cancer. Preclinical evidence has shown that Keystone’s nanoliposome is an effective delivery system for the bioactive compound, targeting cancer cells and ignoring healthy cells.
Get the full story at our sister site, Drug Deliv...
Source: Mass Device - January 5, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Oncology Pharmaceuticals Regulatory/Clearance Wall Street Beat Keystone Nano Source Type: news
Glenmark receives IND application clearance to begin Phase I trial of GBR 1302-BEAT for HER2+ cancer
The US Food and Drug Administration (FDA) has cleared pharmaceutical company Glenmark ’s investigational new drug (IND) application to begin a phase I trial of GBR 1302-BEAT to treat HER2+ cancers. (Source: Drug Development Technology)
Source: Drug Development Technology - January 5, 2017 Category: Pharmaceuticals Source Type: news
Investigational new drug for Alzheimer's scheduled for first study in humans
(Vanderbilt University Medical Center) Vanderbilt University scientists have received notification from the US Food and Drug Administration (FDA) that testing in humans may proceed for an investigational new drug for Alzheimer's disease after more than 10 years of research by scientists at Vanderbilt University and Vanderbilt University Medical Center. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 27, 2016 Category: Global & Universal Source Type: news
Organovo unveils bioprinted liver transplant patches
Organovo (PINK:ONVO) today announced it is developing 3D bioprinted human liver tissue designed for direct transplantation to patients.
The move to human development comes based on “strong results” from preclinical animal model studies, the San Diego, Calif.-based company said. The company expects to pursue a formal preclinical development program.
“We’re excited to introduce an implantable bioprinted liver tissue as the first preclinical candidate in our therapeutic tissue portfolio, and see the early results as extremely promising. The scientific and commercial progress we have already made with ExV...
Source: Mass Device - October 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Regenerative Medicine Organovo Source Type: news
Ablative Solutions wins FDA nod for Phase II chemical denervation trial
Ablative Solutions said today that the FDA approved a Phase II trial of its chemical denervation system for hypertension under its investigational new drug application.
The trial, called Target-BP I, will evaluate the efficacy of Ablative’s Peregrine infusion ablation system, which uses ethanol to interrupt signals from sympathetic nerves in the renal artery to control hypertension.
Ablative Solutions said the 100-patient, randomized, double-blind, sham-controlled trial is slated to enroll patients at 20 global sites.
The Peregrine system is minimally invasive, using a small access site in the femoral artery to snake a c...
Source: Mass Device - September 13, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Ablative Solutions Hypertension Medtronic St. Jude Source Type: news
