FDA accepts Neurovance's IND application for ADHD drug
The US Food and Drug Administration (FDA) has accepted Neurovance's investigational new drug (IND) application for EB-1020 SR, a norepinephrine and dopamine-preferring triple reuptake inhibitor. (Source: Drug Development Technology)
Source: Drug Development Technology - September 24, 2013 Category: Pharmaceuticals Source Type: news
Cleveland Clinic's preventive breast cancer vaccine development takes step forward
(Cleveland Clinic) Cleveland Clinic Innovations has created a spin-off company to develop a preventive breast cancer vaccine based on research from Cleveland Clinic's Lerner Research Institute.The new company, Shield Biotech, will complete preclinical development and seek permission from the FDA to test the vaccine as an investigational new drug in proof-of-concept, first-in-human clinical trials. The trials are expected to start within two years and will take about three years to complete. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 17, 2013 Category: Global & Universal Source Type: news
Wistar receives $1.5 million Department of Defense grant to ready prostate drug for clinical use
(The Wistar Institute) Wistar has received a $1.5 million grant from the US Department of Defense's Congressionally Directed Medical Research Program to prepare a potential prostate cancer drug (Gamitrinib) for human trial. The three-year grant will cover the costs of developing the data necessary to allow the use of Gamitrinib in the clinic. The end goal is to be able to file an Investigational New Drug application with the FDA, says the drug's inventor, Dario C. Altieri, M.D. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 12, 2013 Category: Global & Universal Source Type: news
Boston Children's launches Phase I clinical trial of long-lasting local anesthetic derived from cyanobacteria
Boston Children's Hospital has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for neosaxitoxin, a new local anesthetic derived from cyanobacteria being developed in partnership with Proteus SA, of Santiago, Chile. With the IND approval in hand, the hospital has launched a Phase I clinical study in healthy volunteers... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - August 29, 2013 Category: Consumer Health News Tags: Pain / Anesthetics Source Type: news
Piramal Enterprises Limited Receives IND Approval For P7435, Its Novel DGAT1 Inhibitor For treatment Of Lipid Disorders And Diabetes
Piramal Enterprises Limited “PEL” announced recently that it has received approval from the USFDA for its Investigational New Drug (IND) P7435. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - August 14, 2013 Category: Pharmaceuticals Source Type: news
Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
(Source: What's New at CBER)
Source: What's New at CBER - July 18, 2013 Category: Biomedical Science Source Type: news
UCLA stem cell gene therapy for sickle cell disease advances toward clinical trials
This study was supported in part by a Disease Team I Award from the California Institute for Regenerative Medicine, the state's stem cell research agency, which was created by a voter initiative in 2004. The purpose of the disease team program is to support research focused on one particular disease that leads to the filing of an investigational new drug application with the FDA within four years. The program is designed to speed translational research — research that takes scientific discoveries from the laboratory to the patient bedside. This requires new levels of collaboration between basic laboratory scientists,...
Source: UCLA Newsroom: Health Sciences - July 1, 2013 Category: Universities & Medical Training Source Type: news
Hope For Treatment Of Non-24 Hour Sleep-Wake Disorder In The Blind
An investigational new drug significantly improved a common and debilitating circadian rhythm sleep disorder that frequently affects people who are completely blind, a multicenter study finds. The results were presented at The Endocrine Society's Annual Meeting in San Francisco. The new drug, called tasimelteon, selectively targets the master body clock in the brain, which controls the timing of the sleep-wake cycle, alertness patterns and the timing of some hormones, as well as many other aspects of physiology and metabolism... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 19, 2013 Category: Consumer Health News Tags: Sleep / Sleep Disorders / Insomnia Source Type: news
Kinex to begin glioblastoma clinical trials of KX02
Kinex Pharmaceuticals is set to begin clinical trials of its dual src / pretubulin inhibitor, KX02, as a treatment for glioblastoma, following the FDA's approval of its investigational new drug (IND) application. (Source: Drug Development Technology)
Source: Drug Development Technology - June 5, 2013 Category: Pharmaceuticals Source Type: news
Plexxikon Announces Program Update and Management Changes
Company Files Investigational New Drug Application for PLX7486, Oral Inhibitor Designed to Treat Certain Cancers
BERKELEY, Calif.--(Healthcare Sales & Marketing Network)--Plexxikon Inc., a member of the Daiichi Sankyo Group, has announced the promotions... Biopharmaceuticals, PersonnelPlexxikon, Daiichi Sankyo (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 31, 2013 Category: Pharmaceuticals Source Type: news
Piramal gets USDFA nod for anti-diabetic molecule
Piramal Enterprises today said it has received approval from the USFDA for its investigational new drug, P11187, that aims to target diabetes. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 14, 2013 Category: Pharmaceuticals Source Type: news
FDA Agreement on Mesoblast's Use of Singapore Manufacturing Facility for Clinical Trial Production of Proprietary Mesenchymal Precursor Cells
MELBOURNE, Australia, Feb. 12, 2013 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB) (OTC ADR:MBLTY) today announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition to its United States facility. (Source: Medical News (via PRIMEZONE))
Source: Medical News (via PRIMEZONE) - February 13, 2013 Category: Pharmaceuticals Source Type: news
ImmunoCellular Therapeutics' Investigational New Drug (IND) Application For ICT-140 Allowed By The FDA
ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) announced that the US Food and Drug Administration (FDA) has allowed the investigational new drug (IND) application for ICT-140, paving the way for conducting a clinical trial. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - January 29, 2013 Category: Pharmaceuticals Source Type: news
