Uniformed Services University of the Health Sciences

Scilex Holding Company Announces Positive Type C Meeting with the FDA and Reaches Agreement on Path Forward to File an NDA for SP-102 (SEMDEXATM) in Lumbosacral Radicular Pain (Sciatica)

Retrieved on: 
Thursday, November 2, 2023
Type, FDA, Physical medicine and rehabilitation, Medical Affairs Bureau, Johns Hopkins School of Medicine, Outline of health sciences, Food, Chronic pain, Walter Reed National Military Medical Center, SP-102, Rehabilitation, Physician, Neurology, MD, Injection, Dexamethasone, Psychiatry, PALO, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Uniformed Services University of the Health Sciences, Observation, Senior, Behavioural sciences, File, LRP, Anesthesiology, NDA, Pain, Patient, Pharmaceutical industry, Pain management

The Company has reached agreement with the FDA on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application (“NDA”).

Key Points: 
  • The Company has reached agreement with the FDA on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application (“NDA”).
  • Recently, during the Type C meeting with the FDA, the Company received an advisement on expectations and requirements to file the NDA, including clinical and preclinical data.
  • Scilex intends to file the SP-102 NDA utilizing the 505(b)(2) regulatory pathway to reference the currently approved drug, Dexamethasone sodium phosphate injection.
  • SP-102 (SEMDEXATM) is expected to be administered in up to 3 injections during a 6-month observation period.

ExThera Medical Awarded U.S. Federal Supply Schedule Contract for Seraph 100 Blood Filter

Retrieved on: 
Tuesday, October 10, 2023
Defense, Military, Contracts, Health, COVID-19, Medical Devices, Infectious Diseases, Veterans, News, United States Department of Defense, EUA, Bacteria, United States Department of Veterans Affairs, VA New York Harbor Healthcare System, Veterans' affairs, Indian reservation, FSS, Hospice and palliative medicine, Fungus, VA, Patient, Medical device, Virus, Uniformed Services University of the Health Sciences, SARS-CoV-2, U.S. Department of Defense Strategy for Operating in Cyberspace, Microscopic Observation Drug Susceptibility assay, U.S. Department of Veterans Affairs, Office of Inspector General, Pharmaceutical industry, Seraph

ExThera Medical Corporation has been awarded a 5-year U.S. Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) contract, which allows ExThera to pursue contracts with federal healthcare organizations including the U.S. Department of Veteran Affairs, U.S. Federal Prison System, Indian Reservations, and the Department of Defense.

Key Points: 
  • ExThera Medical Corporation has been awarded a 5-year U.S. Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) contract, which allows ExThera to pursue contracts with federal healthcare organizations including the U.S. Department of Veteran Affairs, U.S. Federal Prison System, Indian Reservations, and the Department of Defense.
  • The contract grants streamlined access to the company’s Seraph® 100 MicroBind® Affinity Blood Filter.
  • Military and VA clinicians have been enthusiastic users of Seraph 100 for the treatment of COVID-19.
  • “ExThera is proud to be contracted by the Federal Supply Schedule, working closely with federal agencies to expand access to the Seraph 100.

Former U.S. Navy Surgeon General Bruce Gillingham Joins Amplifire as a Strategic Advisor

Retrieved on: 
Thursday, September 14, 2023
Knowledge, Adelaide Community Healthcare Alliance, Legion, University of California, San Diego, Navy Distinguished Service Medal, BUMED, Partnership, Emergency medicine, University, Central Waqf Council, Legion of Merit, Science and technology in Asia, Meritorious Service Medal, IEEE 802.1X, Policy, Survival, Second Battle of Fallujah, Uniformed Services University of the Health Sciences, Gillingham, Fleet Marine Force, Achievement Medal, Naval Medical Center San Diego, Organization, United States Department of the Navy, Iraq Campaign Medal, World War II, Patient safety, Marines, Navy, Outline of health sciences, Health, Distinguishing, Pharmaceutical industry, Nursing, Amplifier

As the former 39th Surgeon General of the United States Navy, Gillingham recently retired from 40 years of active-duty service.

Key Points: 
  • As the former 39th Surgeon General of the United States Navy, Gillingham recently retired from 40 years of active-duty service.
  • During his tenure, he led approximately 44,000 Navy medical personnel through the U.S. Navy Bureau of Medicine and Surgery’s (BUMED) most comprehensive transformation since World War II.
  • “Bruce Gillingham’s integrity and reputation for establishing elite patient care in adverse environments is an invaluable resource to Amplifire in healthcare and beyond.
  • “It is a true honor to collaborate with Dr. Gillingham in our shared mission.”
    “I’m thrilled to join the Amplifire team,” Bruce Gillingham expressed.

Redwire BioFabrication Facility Successfully Prints First Human Knee Meniscus on ISS, Paving the Way for Advanced In-Space Bioprinting Capabilities to Benefit Human Health

Retrieved on: 
Thursday, September 7, 2023
Biotechnology, Other Manufacturing, General Health, Health, Health Technology, Aerospace, Manufacturing, Other Health, Luther Forest Technology Campus, Biofabrication, RDW, Redwire, Orbit, 3D bioprinting, Tear resistance, BFF, Uniformed Services University of the Health Sciences, Multimedia, Research, International Space Station, Regenerative medicine, Corporation, NASA, University of Texas Health Science Center at San Antonio, LEO, SpaceX, Injury, Meniscus, Scientific research on the International Space Station, Credit, NYSE, ISS, 3D printing, Communications satellite

This milestone opens the door to improved treatments for meniscal injuries, one of the most common injuries for U.S. Service Members.

Key Points: 
  • This milestone opens the door to improved treatments for meniscal injuries, one of the most common injuries for U.S. Service Members.
  • View the full release here: https://www.businesswire.com/news/home/20230907832309/en/
    Redwire’s 3D BioFabrication Facility successfully 3D printed the first human knee meniscus on the International Space Station, paving the way for advanced in-space bioprinting capabilities to benefit human health.
  • (Credit: Redwire)
    “This is a groundbreaking milestone with significant implications for human health,” said Redwire Executive Vice President John Vellinger.
  • Redwire has developed 20 research facilities for the ISS with 10 currently operating on station to deliver world-leading research.

BIO 300 Featured at the 2023 Military Health System Research Symposium

Retrieved on: 
Tuesday, August 22, 2023
Biotechnology, Health, General Health, Pharmaceutical, Veterans, Infectious Diseases, Military, Other Defense, Defense, COVID-19, Clinical Trials, BIO, Radiation, Acute radiation syndrome, U.S. Department of Defense Strategy for Operating in Cyberspace, Army, ARS, Policy, Uniformed Services University of the Health Sciences, Armed Forces Radiobiology Research Institute, United States Department of the Army, Research, Government, Military personnel, DOD, Federal government of the United States, Humanetics, Patient, Data, Outline of health sciences, Privacy and the US government, FDA, Department of Defence, Vaccine, School of Advanced Warfighting

Updates on the development of Humanetics Corporation’s (Humanetics) new drug candidate, BIO 300, were presented at the 2023 Military Health System Research Symposium (MHSRS), held August 14-17th.

Key Points: 
  • Updates on the development of Humanetics Corporation’s (Humanetics) new drug candidate, BIO 300, were presented at the 2023 Military Health System Research Symposium (MHSRS), held August 14-17th.
  • BIO 300 is being developed for use by military personnel, first responders, and at-risk civilian populations to prevent the harmful and deadly effects of ARS.
  • There is an urgent need for drugs like BIO 300, as no FDA-approved countermeasures provide prophylactic protection against ARS.
  • Professor Singh’s presentation highlighted the research on BIO 300 that has positioned it as the most advanced prophylactic medical countermeasures currently under development for ARS.

U.S. National Institutes of Health to Fund $4.2 Million Contract to Advance Development of Pluri’s PLX-R18 in Conjunction with U.S. DoD as a Medical Countermeasure for Hematopoietic Acute Radiation Syndrome

Retrieved on: 
Tuesday, July 11, 2023
Radiation, Depression, War, ARS, U.S. Department of Defense Strategy for Operating in Cyberspace, Marketing, Drug discovery, Survival, Uniformed Services University of the Health Sciences, Bone marrow, Power plant engineering, Infection, Pluri Inc., Cell, Plural, Bangladesh Technical Education Board, PLUR, Animal, Anemia, AFRRI, TASE, Outline of health sciences, USUHS, Orphan, NIAID, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Thrombocytopenia, NIH, Radiation exposure, Food, Medical imaging, Pharmaceutical industry, Medical device

The work specified by the contract is based on communications with the FDA and will enable Pluri to make significant progress toward marketing approval for PLX-R18.

Key Points: 
  • The work specified by the contract is based on communications with the FDA and will enable Pluri to make significant progress toward marketing approval for PLX-R18.
  • PLX-R18 is developed with the intention of being eligible for purchase by the U.S. Strategic National Stockpile as a medical countermeasure for exposure to nuclear radiation, following FDA approval.
  • H-ARS is a deadly disease that can result from nuclear disasters and radiation exposure.
  • Additionally, PLX-R18 was tested in humans with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT) and was well tolerated with a favorable safety profile.

Immuron Initiates Recruitment of Travelan® Clinical Study

Retrieved on: 
Tuesday, May 30, 2023
IMC, Institutional review board, US Foods, Enterotoxigenic Escherichia coli, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Diarrhea, Clinical trial, United States Army Medical Research and Development Command, Food and Drug Administration, ETEC, Gastroenteritis, ASX, Uniformed Services University of the Health Sciences, Trial of the century, IRB, Ethics, Ageing, FDA, Phase, CHIM, Food, Safety, Pharmaceutical industry, Immuron

MELBOURNE, Australia, May 30, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce that it has received approval from the U.S. Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).

Key Points: 
  • The study has also been granted Institutional Review Board (IRB) human ethics and US Food and Drug Administration (FDA) approvals (ASX announcement December 23, 2022).
  • Immuron is now proceeding with the planned clinical trial in the United States and has initiated recruitment.
  • The clinical study will be conducted by Pharmaron CPC at its FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US.
  • This is one of four clinical trials Immuron has, or is soon to, initiate.

Redwire Subsidiary Wins Contract with European Space Agency to Develop 3D-BioSystem to Advance Tissue Manufacturing Capabilities for Long-Duration Spaceflight and Improving Life on Earth

Retrieved on: 
Tuesday, May 9, 2023
Research, Technology, Other Transport, Science, Air, Biotechnology, Transport, Aerospace, Other Technology, Manufacturing, Other Science, Health, Life, RDW, Redwire, Orbit, 3D, Printing, Tear resistance, Moon, Biomedical Research, European Space Agency, International Space Station, BFF, Uniformed Services University of the Health Sciences, Exploration, Government, Regenerative medicine, 3D bioprinting, Corporation, Organoid, University of Texas Health Science Center at San Antonio, Tissue engineering, Scientific research on the International Space Station, Facility, NYSE, ISS, 3D printing, Mars

Expanding Redwire’s legacy of in-space manufacturing and bioprinting on the International Space Station (ISS) for exploration and improving life on Earth, the 3D-BioSystem Facility will be a “one-stop shop" for tissue engineering and regenerative medicine.

Key Points: 
  • Expanding Redwire’s legacy of in-space manufacturing and bioprinting on the International Space Station (ISS) for exploration and improving life on Earth, the 3D-BioSystem Facility will be a “one-stop shop" for tissue engineering and regenerative medicine.
  • “We are proud to be developing the 3D-BioSystem to advance critical microgravity bioprinting capabilities,” said Erik Masure, Redwire Space NV Managing Director.
  • Like BFF, the 3D-BioSystem Facility has the potential to advance biomedical research to improve life on Earth.
  • Redwire’s on-orbit capabilities are advancing biomedical capabilities, advanced materials manufacturing, and plant biology, all in an effort to accelerate more scientific discovery and deliver more beneficial products to Earth.

Why won’t Minister Anand’s staff meet to discuss the DND’s Live Tissue Training Programme?

Retrieved on: 
Tuesday, May 2, 2023
National security, Seizure, Heart, Vein, Face, Anesthesiology, Defense, Gulf War, LTT, Freedom of information, Advanced trauma life support, Anatomy, Anesthetic, Record, Trauma, Uniformed Services University of the Health Sciences, Artery, DND, Department of National Defence (Canada), Animal Protection Party of Canada, The Hill Times, Anesthesia, Canadian Forces Health Services Group, Animal Protection Party, Animal, APPC, AAC, Poisoning, White, Liberal, Skin, Pig, Medical imaging, Nursing, United States Army, Walls (Louis Tomlinson album), Access

The ad will raise the issue of the use of pigs for military medical training (called “Live Tissue Training” or LTT) by the Department of National Defence.

Key Points: 
  • The ad will raise the issue of the use of pigs for military medical training (called “Live Tissue Training” or LTT) by the Department of National Defence.
  • We have been reaching out to the Minister of National Defence’s office since early January to discuss our findings but have repeatedly been blocked.
  • On January 6th, the Animal Protection Party of Canada released its findings on live tissue training in Defenceless: Animal-Based Trauma Training in the Canadian Military ( http://www.defenceless.ca) .
  • And the U.S. Defense Health Agency (the American equivalent to the Canadian Forces Health Services, which provides the animal-based training in Canada) has deemed live tissue training “outdated and cost prohibitive.”

ImmunityBio Executive Chairman Dr. Patrick Soon-Shiong Delivers the Packard Lecture at Uniformed Services University

Retrieved on: 
Tuesday, April 25, 2023
Research, Genetics, Biotechnology, Health, University, Pharmaceutical, Science, Education, Oncology, National Institute of Allergy and Infectious Diseases, Pancreatic cancer, Medicine, Packard, Hewlett-Packard, Defense, Lecture, Uniformed Services University of the Health Sciences, Infection, Senate, Immunotherapy, Lung, USU, Patient, Outline of health sciences, Immune system, Cancer Moonshot, APP, NIAID, UCLA, FDA, Breast cancer, Whipple, Regulation of tobacco by the U.S. Food and Drug Administration, Tumor microenvironment, Natural killer T cell, Treatment, Food, Nursing, Vaccine, Cancer, MD

ImmunityBio, Inc. ( NASDAQ: IBRX ), a clinical-stage immunotherapy company, today announced that Executive Chairman and Global Chief Scientific and Medical Officer Patrick Soon-Shiong, M.D., has been invited to deliver the 2023 David Packard Award Lecture at the Uniformed Services University of the Health Sciences (USU).

Key Points: 
  • ImmunityBio, Inc. ( NASDAQ: IBRX ), a clinical-stage immunotherapy company, today announced that Executive Chairman and Global Chief Scientific and Medical Officer Patrick Soon-Shiong, M.D., has been invited to deliver the 2023 David Packard Award Lecture at the Uniformed Services University of the Health Sciences (USU).
  • The university extended Dr. Soon-Shiong the invitation to give this prestigious guest lecture in recognition of his “scientific accomplishments as a pioneer” in cancer therapies, immunotherapy, and digital technologies to share genomic information.
  • The lecture, “Activating Natural Killer and T Cells to Induce T Cell Memory for the Treatment of Cancer: The Cancer Moonshot,” will be delivered on Tuesday, April 25, in Bethesda, MD.
  • Previous Packard Award lecturers include Nobel Laureate Dr. Stanley Prusiner and Director of the National Institute of Allergy and Infectious Diseases (NIAID) Dr. Anthony Fauci.