United States National Library of Medicine

NIH Selects ICF for $31 Million in Biomedical and Digital Modernization Work

Retrieved on: 
수요일, 11월 1, 2023

RESTON, Va., Nov. 1, 2023 /PRNewswire/ -- The National Institutes of Health (NIH) National Library of Medicine (NLM) recently awarded global consulting and technology services provider ICF (NASDAQ:ICFI) two agreements with a combined value of $31 million to provide biomedical and technical expertise, as well as data management and digital modernization services.

Key Points: 
  • The first agreement is a new multiple-award blanket purchase agreement (BPA) to collect, curate, and enhance access to critical biomedical and public health data.
  • ICF's efforts will improve data delivery to health researchers, professionals and the public so vital health decisions can quickly be made.
  • ICF has also been awarded five new task orders under the BPA with a combined value of $4 million to provide health expertise, systems maintenance and long-range planning support.
  • The second agreement is an 18-month, $27 million recompete contract for the operation, maintenance and modernization of ClinicalTrials.gov, a project ICF has supported since 2009.

Global Virus Network’s Top Virologists Partner with Monaco to Advance Pandemic Preparedness Across EU Countries

Retrieved on: 
금요일, 10월 20, 2023

Prince Albert II of Monaco, among other dignitaries including from the World Health Organization (WHO) and the GVN.

Key Points: 
  • Prince Albert II of Monaco, among other dignitaries including from the World Health Organization (WHO) and the GVN.
  • Prince Albert II of Monaco said, “I am delighted to support and attend this symposium to improve pandemic preparedness here in Monaco and abroad.
  • We have a duty to remain vigilant, strengthen global governance, and strengthen infrastructure and healthcare systems.
  • Studies showed that phone apps tracking COVID cases and notifying those with exposure, significantly impacted hospitalization and death rates.

Mint & Needle Launches Nonprofit Initiative Providing Free Medical Aesthetic Services for Abuse Survivors

Retrieved on: 
목요일, 10월 12, 2023

The organization, in partnership with international pharmaceutical companies, will provide regenerative medical aesthetic services free of charge to survivors of physical abuse and violence in interpersonal relationships.

Key Points: 
  • The organization, in partnership with international pharmaceutical companies, will provide regenerative medical aesthetic services free of charge to survivors of physical abuse and violence in interpersonal relationships.
  • “Empowerment Beyond Scars exists to transform pain into power,” said Brandi Gregge, MSN, FNP-BC, founder of Empowerment Beyond Scars and founder and medical director of Mint & Needle, a medical aesthetics practice based in Middletown, Delaware.
  • Additionally, Empowerment Beyond Scars will partner with local and national healthcare, nonprofit, and government agencies to share information and educational resources about available treatments and services.
  • Founded in 2019, Mint & Needle has long focused on combining medical and aesthetic expertise to help clients feel empowered in their own skin.

Global Peripheral Blood Mononuclear Cells Research Report 2023: Industry Size, Share, Trends, Opportunities, and Forecasts, 2018-2028 - ResearchAndMarkets.com

Retrieved on: 
화요일, 10월 10, 2023

The growth of the peripheral blood mononuclear cells (PBMC) industry is fueled by increasing customer awareness and a rising preference for antibody development.

Key Points: 
  • The growth of the peripheral blood mononuclear cells (PBMC) industry is fueled by increasing customer awareness and a rising preference for antibody development.
  • As demand for PBMCs in immunotoxicity research grows, the global peripheral blood mononuclear cells market continues to expand.
  • This growing awareness and collaborative R&D efforts positively impact the global peripheral blood mononuclear cells market's growth.
  • Company Profiles: Detailed analysis of the major companies present in global peripheral blood mononuclear cells market.

Creative Medical Technology Holdings Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of StemSpine® using AlloStem™ ("CELZ-201-DDT") Novel Cell Therapy to Treat Chronic Lower Back Pain

Retrieved on: 
화요일, 10월 10, 2023

PHOENIX, Oct. 10, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") (NASDAQ: CELZ), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, today announced that it has received Institutional Review Board ("IRB") approval to proceed with its clinical trial for the treatment of chronic lower back pain with its StemSpine® procedure using AlloStem™ ("CELZ-201-DDT") cell therapy.

Key Points: 
  • The study will enroll 30 individuals suffering from chronic lower back pain caused by Degenerative Disc Disease.
  • An IRB is an FDA-registered consortium that has been formally designated to review and monitor biomedical research involving human subjects.
  • "We are pleased to announce the expeditious receipt of this vital next step in commencing the clinical trial for CELZ-201-DDT," said Timothy Warbington, CEO of Creative Medical Technology.
  • "Studies show that 8% of all adults in the United States, approximately 16 million people, experience chronic lower back pain.

NordicNeuroLab Selects USound as A MEMS Speaker Supplier for Its New MRI-Compatible Headphones

Retrieved on: 
목요일, 9월 28, 2023

The medical headphones will significantly reduce MRI noise and provide patient comfort as well as improving patient - operator communication during MRI examinations.

Key Points: 
  • The medical headphones will significantly reduce MRI noise and provide patient comfort as well as improving patient - operator communication during MRI examinations.
  • (Photo: Business Wire)
    “At NordicNeuroLab we are very pleased to have selected USound as our supplier for MEMS loudspeakers to our new MRI compatible nordicAudioSystem.
  • The technology USound provides allow NordicNeuroLab to bring a state of the art audio system to patients undergoing MRI scans.”
    “We are delighted to announce another important milestone for USound.
  • Our patient-safe MEMS speaker from the Ganymede series, Achelous UT-P2016, has been selected for the production of NordicNeuroLab’s state-of-the-art headphones for MRI screenings.

Allsup Highlights Importance Of Suicide Prevention Awareness, National 988 Hotline This September

Retrieved on: 
수요일, 9월 27, 2023

Allsup , a nationwide provider of Social Security disability, veterans disability appeal, return to work, and healthcare benefits services, joins organizations nationwide in raising awareness and celebrating the first anniversary of the 988 national suicide prevention and mental health crisis hotline.

Key Points: 
  • Allsup , a nationwide provider of Social Security disability, veterans disability appeal, return to work, and healthcare benefits services, joins organizations nationwide in raising awareness and celebrating the first anniversary of the 988 national suicide prevention and mental health crisis hotline.
  • “Our services at Allsup are designed to assist individuals in securing the necessary support, potentially serving as a financial lifeline during their most vulnerable moments.
  • As the nation commemorates Suicide Prevention Month, Allsup encourages everyone to educate themselves and others about suicide awareness and prevention, and the resources available for help.
  • If you or someone you know is in crisis, please call or text the National Suicide Prevention Lifeline at 988 or visit 988lifeline.org for support.

Oxford Biodynamics Announces US Launch of its 94% Accurate EpiSwitch® Prostate Screening Blood Test to Men With Prostate Cancer Risk

Retrieved on: 
화요일, 9월 26, 2023

The current blood screening test, the PSA test, is only 55% accurate, and is considered an unreliable test by many doctors, including the NHS in the UK2.

Key Points: 
  • The current blood screening test, the PSA test, is only 55% accurate, and is considered an unreliable test by many doctors, including the NHS in the UK2.
  • It feels wholly appropriate that the early launch of the test coincides with Prostate Cancer Awareness month," said Dr Jon Burrows, OBD's Chief Executive Officer.
  • Reducing Unnecessary Biopsy During Prostate Cancer Screening Using a Four-Kallikrein Panel: An Independent Replication, Journal of Clinical Oncology [online], 28:15.
  • Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study.

Pathways to Progress: How Orphan Drug Designation Sparks Biotech Transformation

Retrieved on: 
수요일, 9월 20, 2023

NEW YORK, Sept. 20, 2023 /PRNewswire/ -- More than 30 million people in the United States suffer with a rare disease; most of them are receiving no current treatment. Supporting the development and evaluation of new treatments, particularly for rare diseases, is a key priority for the U.S. Food & Drug Administration. As part of that process, the agency can grant Orphan Drug Designation (ODD) to a drug or biological product being developed to prevent, diagnose or treat a rare disease or condition. This designation is intended to spark innovation among biotech companies that are developing treatments for these patient populations, which by definition affect fewer than 200,000 people in the U.S., by providing incentives such as tax credits, user-fee exemptions and up to seven years of market exclusivity after FDA approval. Last month, Genprex Inc. (NASDAQ: GNPX) (Profile) was granted FDA orphan drug designation for its REQORSA(R) immunogene therapy in development for the treatment of small cell lung cancer (SCLC). The Phase 1/2 clinical trial, expected to dose the first patient in the fourth quarter of 2023, uses a combination of REQORSA and Genentech Inc.'s Tecentriq(R) as maintenance therapy in patients with extensive stage small cell lung cancer ("ES-SCLC") who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Genprex joins other companies — including Roche Holding AG ADR (OTCQX: RHHBY), Jazz Pharmaceuticals PLC (NASDAQ: JAZZ), ALX Oncology Holdings Inc. (NASDAQ: ALXO) and Achilles Therapeutics PLC (NASDAQ: ACHL) — that have been granted ODD status or may seek ODD status as they work to develop treatments for rare diseases.

Key Points: 
  • Four decades after the Orphan Drug Act was passed, hundreds of 'orphan' drugs have been approved for use.
  • Genprex's REQORSA Immunogene Therapy has gained both Orphan Drug Designation and Fast Track Designation.
  • Specifically, the report noted that 6,340 orphan drug designations were granted, representing drug development for 1,079 rare diseases.
  • For companies looking to help those in the underserved rare-disease space, an Orphan Drug Designation is the ideal pathway to progress.

Pathways to Progress: How Orphan Drug Designation Sparks Biotech Transformation

Retrieved on: 
수요일, 9월 20, 2023

NEW YORK, Sept. 20, 2023 /PRNewswire/ -- More than 30 million people in the United States suffer with a rare disease; most of them are receiving no current treatment. Supporting the development and evaluation of new treatments, particularly for rare diseases, is a key priority for the U.S. Food & Drug Administration. As part of that process, the agency can grant Orphan Drug Designation (ODD) to a drug or biological product being developed to prevent, diagnose or treat a rare disease or condition. This designation is intended to spark innovation among biotech companies that are developing treatments for these patient populations, which by definition affect fewer than 200,000 people in the U.S., by providing incentives such as tax credits, user-fee exemptions and up to seven years of market exclusivity after FDA approval. Last month, Genprex Inc. (NASDAQ: GNPX) (Profile) was granted FDA orphan drug designation for its REQORSA(R) immunogene therapy in development for the treatment of small cell lung cancer (SCLC). The Phase 1/2 clinical trial, expected to dose the first patient in the fourth quarter of 2023, uses a combination of REQORSA and Genentech Inc.'s Tecentriq(R) as maintenance therapy in patients with extensive stage small cell lung cancer ("ES-SCLC") who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Genprex joins other companies — including Roche Holding AG ADR (OTCQX: RHHBY), Jazz Pharmaceuticals PLC (NASDAQ: JAZZ), ALX Oncology Holdings Inc. (NASDAQ: ALXO) and Achilles Therapeutics PLC (NASDAQ: ACHL) — that have been granted ODD status or may seek ODD status as they work to develop treatments for rare diseases.

Key Points: 
  • Four decades after the Orphan Drug Act was passed, hundreds of 'orphan' drugs have been approved for use.
  • Genprex's REQORSA Immunogene Therapy has gained both Orphan Drug Designation and Fast Track Designation.
  • Specifically, the report noted that 6,340 orphan drug designations were granted, representing drug development for 1,079 rare diseases.
  • For companies looking to help those in the underserved rare-disease space, an Orphan Drug Designation is the ideal pathway to progress.