"Research Investigational New Drug Applications – What You Need To Know" June 25, 2019 Issue
FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 26, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Incysus Therapeutics receives US patent for its technology
Biopharma company Incysus Therapeutics has been issued a patent by the U.S. Patent and Trademark Office for “Drug Resistant Immunotherapy for treatment of a cancer.”
According to the company, the patent covers the treatment of brain cancer with the combination of certain chemotherapies and a T cell genetically modified to confer chemotherapy resistance.
According to the company, Incysus has two Investigational New Drug applications (INDs) approved by the U.S. Food and Drug Administration… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - June 21, 2019 Category: Health Management Authors: Tyler Patchen Source Type: news
Incysus Therapeutics receives US patent for its technology
Biopharma company Incysus Therapeutics has been issued a patent by the U.S. Patent and Trademark Office for “Drug Resistant Immunotherapy for treatment of a cancer.”
According to the company, the patent covers the treatment of brain cancer with the combination of certain chemotherapies and a T cell genetically modified to confer chemotherapy resistance.
According to the company, Incysus has two Investigational New Drug applications (INDs) approved by the U.S. Food and Drug Administration… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 21, 2019 Category: Biotechnology Authors: Tyler Patchen Source Type: news
Personalized Stem Cells, Inc. Submits Investigational New Drug (IND)...
Personalized Stem Cells, Inc. submits Investigational New Drug (IND) application for the treatment of osteoarthritis with stem cells.(PRWeb June 18, 2019)Read the full story at https://www.prweb.com/releases/personalized_stem_cells_inc_submits_investigational_new_drug_ind_application_for_the_treatment_of_osteoarthritis_with_stem_cells/prweb16384983.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - June 18, 2019 Category: Pharmaceuticals Source Type: news
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings
The purpose of this guidance is to assist sponsors of drug and biological products for the 19 treatment of rare diseases in early development and in the planning of and participation in formal 20 pre-investigational new drug application (pre-IND) meetings with the Food and Drug 21 Administration (FD (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news
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 - June 5, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Delaware-developed CRISPR cancer therapy edging closer to human testing
Christiana Care Health System ’s Gene Editing Institute is preparing a preliminary investigational new drug (IND) application that, if approved by the Food and Drug Administration, would allow the institute to begin human testing of a CRISPR therapy it is developing to treat non-small cell lung cancer.
CRISPR, an acronym for Clustered Regularly Interspaced Short Palindromic Repeats, is a technique that allows researchers to alter DNA sequences and modify gene function.
Christiana Care’s Gene… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 6, 2019 Category: American Health Authors: John George Source Type: news
FDA Warns Against Using Young Blood As Medical Treatment
(CNN) — Wannabe vampires, beware: The US Food and Drug Administration warned Tuesday against using plasma infusions from young blood donors to ward off the effects of normal aging as well as other more serious conditions. Plasma, the liquid portion of the blood, contains proteins that help clot blood.
The infusions are promoted to treat a variety of conditions, including normal aging and memory loss as well as serious conditions such as dementia, multiple sclerosis, heart disease and post-traumatic stress disorder.
“There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, t...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - February 19, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Offbeat Blood Donations CNN Source Type: news
Spero Therapeutics Announces FDA Acceptance of IND Application for SPR994
Cambridge, Mass., Feb. 04, 2019 (Globe Newswire) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections, today announced the acceptance by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for SPR994, Spero’s lead product candidate designed to be...This story is related to the following:Pharmaceuticals (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - February 5, 2019 Category: Medical Devices Source Type: news
Critical impacts of the government shutdown on the FDA and clinical research
Rachel Martukovich, Clinical Research Associate for IMARC Research, Inc.
The recent partial government shutdown, which is now the longest in US history, has various stakeholders in the medical device and pharmaceutical industries concerned with the potential impact on the world of clinical research. The FDA is one of the federal agencies most affected, as the budget for fiscal year 2019 is on hold until the shutdown ends and Congress can appropriate funds.
FDA Commissioner Scott Gottlieb recently tweeted that “The lapse in funding represents one of the most significant operational challenges in FDA’s recent history...
Source: Mass Device - January 17, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news
Partial Government Shutdown's Impact On FDA Drug Approvals
Besides the government shutdown ' s impact on food inspection, there are also short-term and possibly longer-term implications for drug development. The FDA has suspended reviews of existing Investigational New Drug (IND) and Biologics License Application (BLA) applications not covered by user fees. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 10, 2019 Category: Pharmaceuticals Authors: Joshua Cohen, Contributor Source Type: news
Nobilis files IND for trial to study drug-device PTSD therapy
Nobilis Therapeutics said yesterday that it filed an investigational new drug application with the FDA to kick off a Phase IIb trial of its NBTX-001 drug-device PTSD therapy.
The Portland, Ore.-based company is developing a portable inhalation device designed to deliver a xenon gas mixture.
Get the full story at our sister site, Drug Delivery Business News.
The post Nobilis files IND for trial to study drug-device PTSD therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - January 8, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Food & Drug Administration (FDA) Neurological Pharmaceuticals nobilistherapeutics Source Type: news
$5.1 million grant will fund research to develop stem cell-based therapy for blinding eye conditions
Scientists at the UCLA Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research and the Stein Eye Institute have been awarded a $5.1 million grant from the California Institute for Regenerative Medicine to advance the development of a novel therapy for blinding retinal conditions.The award by the California Institute for Regenerative Medicine, or CIRM, will support the development of a treatment that will use patients ’ own skin cells to generate autologous induced pluripotent stem cells to derive retinal pigment epithelium cells, which are lost in many blinding eye conditions. The team, led by Dr...
Source: UCLA Newsroom: Health Sciences - October 19, 2018 Category: Universities & Medical Training Source Type: news
