FNIH

Andelyn Biosciences Selected as Viral Vector Manufacturing Partner for the Foundation for the National Institutes of Health (FNIH) Accelerating Medicines Partnership® (AMP®) Bespoke Gene Therapy Consortium (BGTC)

Retrieved on: 
Wednesday, February 28, 2024
Bangladesh Technical Education Board, FNIH, NPHP5, NIH, FDA, Partnership, Food, Bespoke Gene Therapy Consortium, AMP, CDMO, Organization, Associate, Patient, Disease, AAV, Pharmaceutical industry

COLUMBUS, Ohio, Feb. 28, 2024 /PRNewswire/ -- Andelyn Biosciences, Inc. , a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has been selected to manufacture adeno-associated vectors (AAV) therapies in its suspension platform for several programs under the Foundation for the National Institutes of Health (FNIH) Accelerating Medicines Partnership® (AMP®) Bespoke Gene Therapy Consortium (BGTC).

Key Points: 
  • COLUMBUS, Ohio, Feb. 28, 2024 /PRNewswire/ -- Andelyn Biosciences, Inc. , a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has been selected to manufacture adeno-associated vectors (AAV) therapies in its suspension platform for several programs under the Foundation for the National Institutes of Health (FNIH) Accelerating Medicines Partnership® (AMP®) Bespoke Gene Therapy Consortium (BGTC).
  • BGTC has chosen to focus on eight rare disease programs , with Andelyn selected to optimize and scale the AAV therapy processes for the treatments of CNGB1 Retinitis Pigmentosa 45 and NPHP5 retinal degeneration.
  • Matt Niloff, Chief Commercial Officer of Andelyn, commented, "As a long-standing pioneer in AAV gene therapies with a focus on patients, we have great synergies with the BGTC.
  • With exceptional quality and scalable end-to-end development and manufacturing capabilities across its three Columbus, Ohio facilities, Andelyn is enabling the progression of life-altering gene therapies for rare and prevalent diseases.

Enigma Biomedical - USA Announces Appointment of Hartmuth Kolb, PhD as Chief Scientific Officer

Retrieved on: 
Tuesday, February 13, 2024
Research, General Health, Radiology, Pharmaceutical, Biometrics, Medical Devices, Health Technology, Science, Biotechnology, Neurology, Other Science, Health, Organic chemistry, FNIH, Neuroscience, Doctor of Philosophy, Nobel Prize in Chemistry, NIH, Professor, SVP, Johnson & Johnson, Hartmuth C. Kolb, Neurodegenerative disease, Imperial College London, Biomedicine, Biomarker, Siemens Healthineers, Enigma, EB, Scripps Research, CNS, Associate, Disease, CSO, Diagnosis, PET, Click chemistry, Central nervous system disease, Nobel Prize, Management

Enigma Biomedical USA (EB) today announced the appointment of Hartmuth Kolb, PhD as Chief Science Officer (CSO).

Key Points: 
  • Enigma Biomedical USA (EB) today announced the appointment of Hartmuth Kolb, PhD as Chief Science Officer (CSO).
  • Dr. Kolb’s passion for innovation and scientific rigor has driven his extensive career and broad recognition.
  • He will join Enigma at the beginning of March, 2024.
  • In his 10 year tenure at Johnson & Johnson Innovative Medicine, he served as the Vice President, Neuroscience Biomarkers and Global Head of Imaging.

The Foundation for the National Institutes of Health Launches First Public-Private Partnership for Early Detection of Preeclampsia

Retrieved on: 
Monday, February 12, 2024
Health, Family, Consumer, Other Health, Surgery, Other Science, Research, Parenting, Managed Care, General Health, Hospitals, Baby, Maternity, Science, Women, Master of Science, Bangladesh Technical Education Board, FNIH, Merck, Woman, Doctor of Philosophy, NICHD, NIH, Pregnancy, FDA, Partnership, Food, Pre-eclampsia, Mother, Ohio State University, Pappalysin-1, Letter, Risk, Human development, Cedars-Sinai Medical Center, Biomarker, Disorder, Organization, Task force, MPH, Thermo Fisher Scientific, PIGF, Child, Bill, DSM-IV codes, Mortality, George Washington University, Dietary supplement

The Foundation for the National Institutes of Health (FNIH) today announces the launch of a new public-private partnership to develop tools to identify pregnant women at high risk of early-onset preeclampsia.

Key Points: 
  • The Foundation for the National Institutes of Health (FNIH) today announces the launch of a new public-private partnership to develop tools to identify pregnant women at high risk of early-onset preeclampsia.
  • Preeclampsia is a serious pregnancy-related hypertensive disorder that can lead to maternal and neonatal deaths and long-term negative health outcomes.
  • The disorder is becoming more prevalent in the United States, with women of color more likely to be affected and experience poor outcomes.
  • Currently, preeclampsia risk is determined early in pregnancy using a combination of maternal medical history and clinical risk factors.

Atossa Therapeutics Announces Full Enrollment of (Z)-Endoxifen Arm of I-SPY 2 Clinical Trial

Retrieved on: 
Wednesday, February 7, 2024
Biomarker, Enzyme inhibitor, Breast cancer, Clinical trial, Patient, Incidence, Recurrence, Food, Therapy, EOP, FNIH, Neoplasm, Bangladesh Technical Education Board, Doctor of Philosophy, Woman, Medical imaging

SEATTLE, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that the (Z)-endoxifen arm of the ongoing Phase 2 I-SPY 2 clinical trial has fully enrolled.

Key Points: 
  • SEATTLE, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that the (Z)-endoxifen arm of the ongoing Phase 2 I-SPY 2 clinical trial has fully enrolled.
  • In the study, (Z)-endoxifen, Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), is being evaluated as a neoadjuvant treatment for newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer.
  • “Estrogen receptor positive breast cancer accounts for over 80% of all breast cancer diagnoses and unfortunately, the current neoadjuvant treatment options for these patients are sub-optimal.
  • The (Z)-endoxifen treatment arm, which enrolled 20 patients, is part of the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP).

The Foundation for the National Institutes of Health Announces Publication of Regulatory Playbook to Advance AAV Gene Therapies for Rare Diseases

Retrieved on: 
Tuesday, February 6, 2024
Health, General Health, Partnership, AMP, Playbook, Knowledge, Investigational New Drug, Research, NIH, Government, Clinical trial, Bespoke Gene Therapy Consortium, Patient, IND, Patient safety, FDA, Publication, Investment, MPH, Food, AAV, Disease, Drug development, FNIH, Associate, Bangladesh Technical Education Board, Doctor of Philosophy, Organization, Pharmaceutical industry

The Foundation for the National Institutes of Health (FNIH) today announces the online publication of the first “playbook” designed to help accelerate the development of adeno-associated virus (AAV) gene therapies for rare diseases.

Key Points: 
  • The Foundation for the National Institutes of Health (FNIH) today announces the online publication of the first “playbook” designed to help accelerate the development of adeno-associated virus (AAV) gene therapies for rare diseases.
  • AMP BGTC is a public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), life science companies, and patient foundations.
  • “Gene therapies offer promise to thousands of patients with rare diseases, but progress is slowed by uncertainties about manufacturing and a clear regulatory path.
  • The playbook was created as a “one-stop-shop guide” for clinical and drug development researchers who are working to bring AAV gene therapies to rare disease patients.

The Foundation for the National Institutes of Health Announces Appointment of Nina Kjellson and Charles Reinhart III to the Board of Directors

Retrieved on: 
Thursday, January 18, 2024
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, FNIH, Woman, Stanford University, Biology, Lehigh University, Accounting, Neuroscience, Biomedical Research, University, Government, CPA, MBA, Entrepreneurship, Acquisition, General partnership, MPH, Bangladesh Technical Education Board, Management

The Foundation for the National Institutes of Health (FNIH) announces two new additions to the FNIH Board of Directors, Nina Kjellson, General Partner at Canaan, and Charles Reinhart III, Chief Financial Officer at Pacira BioSciences, Inc.

Key Points: 
  • The Foundation for the National Institutes of Health (FNIH) announces two new additions to the FNIH Board of Directors, Nina Kjellson, General Partner at Canaan, and Charles Reinhart III, Chief Financial Officer at Pacira BioSciences, Inc.
  • The new directors bring decades of collective expertise and entrepreneurship in finance, biopharma, and digital health to the Board.
  • “We are honored to welcome Nina and Charles to the FNIH Board,” said Steve Paul, MD, Board Chairman.
  • As a leader of Canaan’s Women of Venture program, Ms. Kjellson is a vocal advocate for women entrepreneurs and investors.

Xtalks Life Science Podcast: 2023 Year in Review and Outlook for 2024

Retrieved on: 
Tuesday, January 2, 2024
Knowledge, Atmosphere, Food, Food and Drug Administration, NASH, Biotechnology, Tune, FDA, Vaccination, Apple, News, Bangladesh Technical Education Board, Merck, FNIH, Pharmaceutical industry

TORONTO, Jan. 2, 2024 /PRNewswire-PRWeb/ -- The Xtalks editorial team is celebrating nearly three years of the Xtalks Life Science Podcast. Hosted by Ayesha Rashid, Senior Life Science Journalist at Xtalks and fellow editorial team members Sydney Perelmutter and Vera Kovacevic, the podcast features weekly discussions on the latest news, trends and insights from experts across the pharmaceutical, biotechnology and medical device industries.

Key Points: 
  • TORONTO, Jan. 2, 2024 /PRNewswire-PRWeb/ -- The Xtalks editorial team is celebrating nearly three years of the Xtalks Life Science Podcast .
  • There is a lot planned for the Xtalks Life Science Podcast in 2024 so stay tuned!
  • Tune into the Xtalks Life Science Podcast, which will resume on Wednesday, January 10, 2024, for continued news, conversations and insights!
  • Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

The FNIH Awards 2023 Charles A. Sanders, M.D., Partnership Award to NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, GSK, and the O’Neill Family

Retrieved on: 
Monday, September 18, 2023
Children, Biotechnology, Baby, Maternity, Other Health, Health, Women, Pharmaceutical, Research, Consumer, Science, Clinical Trials, GSK, DNA, The New England Journal of Medicine, FNIH, Prevalence, Awards ceremony, Kidney cancer, Molina Healthcare, Clinical trial, Global Smoke-Free Partnership Award, Dean, Woman, Biomedical sciences, PRIORITY, Biomarker, NICHD, Lung, Doctor of Philosophy, Bill & Melinda Gates Foundation, Person, Bangladesh Technical Education Board, National Institutes of Health Clinical Center, Organization, NHLBI, Azithromycin, Charles, MD, Patient, Tuberculosis, World Cultural Council 29th Award Ceremony, Child, Anemia, Human development, Bill, Edmond, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Transplant, Death, NIH, National Heart, Lung, and Blood Institute, Renal cell carcinoma, Nursing, Pharmaceutical industry

The Foundation for the National Institutes of Health (FNIH) has named the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, GSK, and the O’Neill Family as recipients of the 2023 Charles A. Sanders, M.D., Partnership Award .

Key Points: 
  • The Foundation for the National Institutes of Health (FNIH) has named the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, GSK, and the O’Neill Family as recipients of the 2023 Charles A. Sanders, M.D., Partnership Award .
  • The Partnership Award recognizes persons or organizations that have made significant contributions to the FNIH’s work in support of the mission of the National Institutes of Health (NIH).
  • The Azithromycin Prevention in Labor Use Study (A-PLUS) assessed low-cost, sustainable interventions to improve maternal and child health.
  • The Charles A. Sanders, M.D., Partnership Award is named for the former Chairman of the FNIH Board of Directors.

The FNIH Announces Study Results Published in Nature Medicine Showing That Liver Disease Can Be Diagnosed Using Noninvasive Blood Tests

Retrieved on: 
Thursday, September 7, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Knowledge, FNIH, Partnership, Drug development, Therapy, NASH, Liver disease, Research fellow, AUROC, Non-alcoholic fatty liver disease, Biomarker, Doctor of Philosophy, Bangladesh Technical Education Board, DSM-IV codes, Patient engagement in Canada, Liver cancer, Foundation for the National Institutes of Health, Kidney, Patient, Risk, Blood, Liver, Fatty liver disease, Mortality, United, Digestive, FDA, MPH, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cirrhosis, Food, Safety, Biopsy, Medical imaging, Nature Medicine, MD

The research is part of the Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project, a public-private partnership bringing together the FDA, academic researchers, and industry partners to rigorously evaluate blood and imaging tests to measure the presence of liver disease.

Key Points: 
  • The research is part of the Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project, a public-private partnership bringing together the FDA, academic researchers, and industry partners to rigorously evaluate blood and imaging tests to measure the presence of liver disease.
  • Although several companies have developed such tests, none have met the burden of proof needed for FDA regulatory approval.
  • This lack of approval limits the use of these tests for diagnosing NASH and recruiting patients into studies to develop therapies.
  • For more information, visit Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) | FNIH .

The FNIH Awards 2023 Trailblazer Prize for Clinician-Scientists to Vinod Balachandran, M.D., from Memorial Sloan Kettering Cancer Center for Pancreatic Cancer Research

Retrieved on: 
Thursday, August 24, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Memorial Sloan Kettering Cancer Center, Pancreatic cancer, American Society for Clinical Investigation, GSK, Survivor, Trailblazer, FNIH, University, Awards ceremony, Disability, Neoplasm, Physician, Cancer, University of Iowa, American Physician Scientists Association, Biomedical sciences, AAP, Research, Bangladesh Technical Education Board, Messenger, Association of American Physicians, Charles, Global Smoke-Free Partnership Award, Patient, World Cultural Council 31st Award Ceremony, MSK, Edmond, Society, Pharmaceutical industry, Vaccine

The Foundation for the National Institutes of Health (FNIH) has awarded its sixth annual Trailblazer Prize for Clinician-Scientists to Vinod Balachandran, M.D.

Key Points: 
  • The Foundation for the National Institutes of Health (FNIH) has awarded its sixth annual Trailblazer Prize for Clinician-Scientists to Vinod Balachandran, M.D.
  • , at Memorial Sloan Kettering Cancer Center (MSK), for his groundbreaking research on immunotherapies for pancreatic cancer.
  • This pioneering work has the potential to transform the treatment of pancreatic cancer, one of the deadliest malignancies, and provide proof of concept for future cancer vaccines.
  • He is also immunology group leader in the David M. Rubenstein Center for Pancreatic Cancer Research at MSK.