United States Public Health Service

BioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501 (sublingual dexmedetomidine) for Potential Treatment of Opioid Use Disorder (OUD)

Retrieved on: 
Monday, November 6, 2023

NEW HAVEN, Conn., Nov. 06, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced an update on the National Institute on Drug Abuse (NIDA)-funded trial evaluating BXCL501 (sublingual dexmedetomidine) as a potential treatment for opioid use disorder (OUD).

Key Points: 
  • NIDA has requested Columbia University, the trial coordinator, to add a fourth site to target trial completion in 2024.
  • After this time, BioXcel Therapeutics plans to seek FDA feedback on potential registrational paths.
  • “With BXCL501, we are excited about the potential to treat patients who are physically dependent on illicit and prescription opioids.
  • In addition to OUD as an indication, BioXcel Therapeutics has been awarded key opportunities for the development of BXCL501 in post-traumatic stress disorder and alcohol use disorder.

Celltrion USA Announces U.S. FDA Approval of ZYMFENTRA® (infliximab-dyyb), the First and Only Subcutaneous infliximab, for the Treatment of People With Inflammatory Bowel Disease

Retrieved on: 
Monday, October 23, 2023

Based on the results of the LIBERTY UC and LIBERTY CD studies, ZYMFENTRA demonstrated superiority in the primary endpoints of clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD, over a 54-week study period.

Key Points: 
  • Based on the results of the LIBERTY UC and LIBERTY CD studies, ZYMFENTRA demonstrated superiority in the primary endpoints of clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD, over a 54-week study period.
  • The overall safety profile of ZYMFENTRA was similar to that of placebo during maintenance period in both studies with no new safety signals seen.2,3
    “There remains an unmet need for patients who suffer from the day-to-day burden of living with moderately to severely active Crohn’s disease and ulcerative colitis,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA.
  • “As someone dedicated to improving the lives of patients with IBD, I am excited to see data supporting the efficacy and safety of a new formulation offering convenience and improved access to a well-known and proven drug,” said Dr. Andres Yarur of Cedars-Sinai Medical Center.
  • ZYMFENTRA will be under patent protection by 2037 for its dosage form and route of administration by 2040.

Vistant Selected To Support Defense Health Agency’s National Capital Region Logistics Program

Retrieved on: 
Thursday, October 12, 2023

Vistant will provide program management support for DHA’s National Capital Region (NCR) Medical Directorate Logistics & Acquisition Support Program.

Key Points: 
  • Vistant will provide program management support for DHA’s National Capital Region (NCR) Medical Directorate Logistics & Acquisition Support Program.
  • Under this two-year, $3.7 million project, Vistant will staff, manage, and operate logistics for the NCR from the Walter Reed National Military Medical Center annex.
  • Earlier this year, Vistant was awarded a contract to provide operational support through DHA’s Clinical Operations Program Management Office.
  • Vistant paralegal experts now support active duty and retired service members of the Army, Navy, Air Force, Marines, Coast Guard, Public Health Service, and their dependents, as well as civilian employees of the Department of Defense.

FINRA Foundation and AFCPE® Announce 2023 FINRA Foundation Military Spouse Fellows

Retrieved on: 
Tuesday, August 29, 2023

The FINRA Investor Education Foundation (FINRA Foundation) and the Association for Financial Counseling and Planning Education® (AFCPE®) announced today the recipients of 2023 FINRA Foundation Military Spouse Fellowship.

Key Points: 
  • The FINRA Investor Education Foundation (FINRA Foundation) and the Association for Financial Counseling and Planning Education® (AFCPE®) announced today the recipients of 2023 FINRA Foundation Military Spouse Fellowship.
  • The FINRA Foundation Military Spouse Fellowship addresses both the financial readiness and spouse employment challenges of military families by providing opportunities for portable careers in financial counseling to military spouses.
  • Moreover, un- or underemployment among military spouses is common," said Gerri Walsh, President of the FINRA Foundation.
  • “We are thrilled to welcome the newest class of FINRA Foundation Fellows,” said Rachael DeLeon, AFCPE Executive Director.

FINRA Foundation and AFCPE® Announce 2023 FINRA Foundation Military Spouse Fellows

Retrieved on: 
Tuesday, August 29, 2023

WASHINGTON, Aug. 29, 2023 /PRNewswire/ -- The FINRA Investor Education Foundation (FINRA Foundation) and the Association for Financial Counseling and Planning Education® (AFCPE®) announced today the recipients of the 2023 FINRA Foundation Military Spouse Fellowship.

Key Points: 
  • WASHINGTON, Aug. 29, 2023 /PRNewswire/ -- The FINRA Investor Education Foundation (FINRA Foundation) and the Association for Financial Counseling and Planning Education® (AFCPE®) announced today the recipients of the 2023 FINRA Foundation Military Spouse Fellowship.
  • The FINRA Foundation Military Spouse Fellowship addresses both the financial readiness and spouse employment challenges of military families by providing opportunities for portable careers in financial counseling to military spouses.
  • Moreover, un- or underemployment among military spouses is common," said Gerri Walsh, President of the FINRA Foundation.
  • "We are thrilled to welcome the newest class of FINRA Foundation Fellows," said Rachael DeLeon, Executive Director of AFCPE.

IPEC and COF Celebrate the Winners of the 2023 Interprofessional Education Collaboration Award

Retrieved on: 
Tuesday, August 1, 2023

On June 29, the Interprofessional Education Collaborative (IPEC) and the PHS Commissioned Officers Foundation for the Advancement of Public Health (COF) hosted a ceremony at the Association of American Medical Colleges (AAMC) Learning Center in Washington, DC to celebrate innovation in interprofessional engagement.

Key Points: 
  • On June 29, the Interprofessional Education Collaborative (IPEC) and the PHS Commissioned Officers Foundation for the Advancement of Public Health (COF) hosted a ceremony at the Association of American Medical Colleges (AAMC) Learning Center in Washington, DC to celebrate innovation in interprofessional engagement.
  • “On behalf of IPEC and COF, it is my pleasure to recognize Dr. Meg Zomorodi and the collaborators at the University of North Carolina-Chapel Hill and the North Carolina Area Health Education Centers as the recipients of the 2023 Excellence in Interprofessional Education (IPE) Collaboration Award," said U.S. Public Health Service Rear Admiral (retired) Randall J.F.
  • RIPHI is a true ‘win-win’ for our students, partners, and all those we serve.”
    The IPEC Membership Meeting and IPEC/COF Award Ceremony also featured poster presentations by honorable mention finalists.
  • “It was great to recognize the work of these teams and pioneers,” said Alison J. Whelan, MD, IPEC Board Chair and AAMC Chief Education Officer.

What does ending the emergency status of the COVID-19 pandemic in the US mean in practice? 4 questions answered

Retrieved on: 
Wednesday, May 10, 2023

The COVID-19 pandemic’s public health emergency status in the U.S. expires on May 11, 2023.

Key Points: 
  • The COVID-19 pandemic’s public health emergency status in the U.S. expires on May 11, 2023.
  • And on May 5, the World Health Organization declared an end to the COVID-19 public health emergency of international concern, or PHEIC, designation that had been in place since Jan. 30, 2020.
  • While the global emergency status has ended, COVID-19 is still an “established and ongoing health issue,” he said.

1. What does ending the national emergency phase of the pandemic mean?

    • Ending the federal emergency reflects both a scientific and political judgment that the acute phase of the COVID-19 pandemic crisis has ended and that special federal resources are no longer needed to prevent disease transmission across borders.
    • In practical terms, it means that two declarations – the federal Public Health Emergency, first declared on Jan. 31, 2020, and the COVID-19 national emergency that former President Donald Trump announced on March 13, 2020, are expiring.
    • Declaring those emergencies enabled the federal government to cut through mountains of red tape to respond to the pandemic more efficiently.

2. What domestic policies are changing?

    • Another analysis projected that as many as 24 million people will be kicked off the Medicaid rolls.
    • Before the pandemic, states required people to prove every year that they met income and other eligibility requirements.
    • In March 2020, Congress enacted a continuous enrollment provision in Medicaid that prevented states from removing anyone from their rolls during the pandemic.
    • In a December 2022 appropriations bill, Congress passed a provision that ended continuous enrollment on March 31, 2023.
    • The array of telehealth services that Medicare began covering during the pandemic will continue to be covered through December 2024.

3. What does this mean for the status of the pandemic?

    • But declaring an end to the emergency doesn’t mean a return to business as usual.
    • She called for more federally funded research into therapeutics and durable vaccines that protect against many variants.
    • With the end of the emergency, the CDC is also changing the way it presents its COVID-19 data to a “sustainable national COVID-19 surveillance” model.

4. How will state and local pandemic measures be affected?

    • Most U.S. states, however, have ended their own public health emergency declarations.
    • Marian Moser Jones receives funding from the National Endowment for the Humanities and The American Public Health Association.
    • In the past she has received funding from the National Institutes of Health and the American Association for the History of Nursing, as well as the State of Maryland.

DHA Selects Vistant for Clinical Operations Support

Retrieved on: 
Wednesday, April 19, 2023

Vistant will deliver additional support services to the Clinical Operations Program Management Office (PMO).

Key Points: 
  • Vistant will deliver additional support services to the Clinical Operations Program Management Office (PMO).
  • Vistant (formerly PM Consulting Group) will provide expertise in credentialing and privileging, patient safety, and infection control to support the DHA Clinical Operations PMO.
  • The company will be responsible for offering data-driven guidance and sound recommendations to improve patient safety and clinical operations across military health services.
  • In addition to the clinical operations work, the company was awarded an expansion of its contract with the DHA Department of Paralegal at Walter Reed National Military Medical Center (WRNMMC) and Fort Belvoir.

Results of Pre-MEASURE Study By NMDP/Be The Match, CIBMTR, and the NHLBI Published in JAMA

Retrieved on: 
Tuesday, March 7, 2023

It provides valuable insight into MRD as a predictive tool to inform HCT decisions and individualize treatment to improve outcomes.

Key Points: 
  • It provides valuable insight into MRD as a predictive tool to inform HCT decisions and individualize treatment to improve outcomes.
  • Unlocking the potential of precision medicine to improve it further will require a firm foundation of evidence.
  • The Pre-MEASURE study is the largest cohort of next-generation sequencing-based MRD testing (NGS-MRD) prior to allogeneic HCT for AML to date.
  • This content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Recovery Centers of America Becomes a Humana Military Participating Provider

Retrieved on: 
Wednesday, March 1, 2023

King of Prussia, PA, March 01, 2023 (GLOBE NEWSWIRE) -- Recovery Centers of America (RCA), a healthcare network of substance use disorder treatment facilities on the East Coast and in the Midwest, today announced an agreement to become a Humana Military participating provider.

Key Points: 
  • King of Prussia, PA, March 01, 2023 (GLOBE NEWSWIRE) -- Recovery Centers of America (RCA), a healthcare network of substance use disorder treatment facilities on the East Coast and in the Midwest, today announced an agreement to become a Humana Military participating provider.
  • Humana Military offers healthcare services to more than six million active duty and retired military personnel and their families in the eastern United States.
  • “Recovery Centers of America is excited and honored to be selected as a participating provider with Humana Military, bringing vital, evidence-based addiction treatment services to our military community,” said J. Brian O’Neill, Chief Executive Officer of RCA.
  • If you or your loved one are struggling with drug or alcohol addiction and need help, the staff at Recovery Centers of America is here to help.