Epidemiology

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Retrieved on: 
Friday, February 16, 2024
BRAF, SAN, Neoplasm, Cohort, Immune system, Kaplan–Meier estimator, Immunotherapy, TIL, Information, FDA, Melanoma, Food, News, Cytopenia, Infection, PD-1, AIM, National Cancer Institute, Respiratory failure, Travel, Epidemiology, Interim, Safety, Physician, BRAF V600, Patient, Journal, RECIST, ATC, Disease, Clinical trial, Kidney failure, MEK, Pharmaceutical industry

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Key Points: 
  • This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response.
  • AMTAGVI is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer.
  • “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.
  • Iovance will host a conference call and live audio webcast today to discuss the FDA approval of AMTAGVI.

New Report Reveals Insights into Prehospital Heat-Related Incidents Attended by EMS

Retrieved on: 
Friday, February 16, 2024
Collaboration, Epidemiology, Public, EMS, Health, Research, Nursing

released the latest report as part of the Collaborate™ research initiative.

Key Points: 
  • released the latest report as part of the Collaborate™ research initiative.
  • The report, " Prehospital Heat Illness-Related Incidents from 2019 to 2023 ," analyzes the characteristics of heat-related incidents attended by EMS in the United States from 2019 to 2023.
  • The research provides insights into the patient needs associated with heat-related incidents, which can help strengthen training, quality of care, resource allocation and alternative healthcare options to support individuals that find themselves sensitive to heat.
  • For more information on the Collaborate program and how to utilize the report findings, please visit www.imagetrend.com/Collaborate .

Alembic Receives $14 Million Series A Funding

Retrieved on: 
Thursday, February 15, 2024
Technology, Professional Services, Digital Marketing, Social Media, Data Analytics, Search Engine Optimization, Search Engine Marketing, Blogging, Content Marketing, Other Communications, Public Relations, Investor Relations, Marketing, Advertising, Communications, Software, Data Management, Artificial Intelligence, Brazing, Acquisition, Engineering, Social media, Fortune 500, AI, Intelligence, ROI, Radio, Mathematics, Liquid, Organization, Texas A&M University, Movement, DreamWorks, Mortality, Epidemiology, MRI, NVIDIA, Cryptocurrency

Alembic , the leading holistic marketing attribution platform for enterprises, today announced it received $14 million in series A funding.

Key Points: 
  • Alembic , the leading holistic marketing attribution platform for enterprises, today announced it received $14 million in series A funding.
  • Alembic analyzes and evaluates unstructured and complex data to predict marketing ROI and future revenue based on the results.
  • Alembic is proud to have Fortune 200 and top brands as customers, including NVIDIA, Texas A&M and North Sails.
  • WndrCo is thrilled to lead the series A round for Alembic and enable the company to introduce its innovative solution to a wider audience.

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on: 
Wednesday, February 14, 2024
Real-World Evidence, ACT, Data science, CMD, Toxicity, Budesonide, Paliperidone palmitate, Drug development, E20, RWE, ETF, Human, Pharmacology, Machine learning, Quantitative systems pharmacology, Register, Radiopharmaceutical, Legislation, QST, M12, CAT, Salt, Pharmacoepidemiology, Dasatinib, Algorithm, M13, Azacitidine, Methylphenidate, Clinical trial, Health, M&S, Methodology, PBPK, HMA, Adverse drug reaction, European, CHMP, HTA, Biomarker, Big data, Digoxin, Betahistine, Multi, Therapy, Medication package insert, Simulation, LALA, ADR, US FDA, Language, RWD, Corr, PBBM, WPS, SAWP, Committee, Pharmacovigilance, Peptide, ICH, CPS, Contribution, Good, QSP, Model, Epidemiology, Artificial intelligence, RPS, Research, Reproduction, PRAC, EMA, Health Canada, AI, Cross, Gastrointestinal tract, Paliperidone, Communication, Risk, Melatonin, MWP, CP, Medicine, Patient, Biostatistics, Pharmacokinetics, Oligonucleotide, E21, M14, Q&A, Drug, M15, Medical device

Industry level .................................................................................................. 13

Key Points: 
    • Industry level .................................................................................................. 13

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 2/14

      1.

    • A reflection paper
      (RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 3/14

      plan, and it is envisaged that something similar may be needed for other emerging treatment
      modalities (e.g., peptides).

    • Guideline work led by other working parties
      ?

      Revision of the guideline on the requirements for clinical documentation for orally inhaled
      products (CPMP/EWP/4151/00 Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 4/14

      The planned concept papers (CPs) will formulate problem statements for potential workshops and
      subsequent guidance documents will be informed and enriched by the outcome of discussions of
      workshops to be held in 2024.

    • Guideline work led by other working parties and committees
      ?

      Revision of Guidance on the investigation of medicinal products in the term and preterm
      neonate (EMEA/536810/2008).

    • There is a need for
      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 5/14

      new guidance in these areas to ensure these novel approaches meet the required evidentiary
      standards and facilitate their evaluation.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 6/14

      ?

      Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 7/14

      ?

      Provide appropriate support to the EU network for generic and hybrid medicines including
      product-specific requirements.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 8/14

      2.3.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
      based biopharmaceutics modelling (PBBM).

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 9/14

      ?

      In order to support adequate evaluation of all methodology MWP will aim to facilitate an
      increase in presence and visibility in relevant committees of methodological expertise from
      across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 10/14

      ?

      Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
      2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
      depot) and melatonin have been prioritised as the next in series for drafting.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 11/14

      4.2.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
      assessment.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 12/14

      ?

      To deliver an improved access to raw data (e.g.

    • ?

      Propose regulatory research priorities for funders in across the activities of Methodology
      Working Party, including in the big data area.

    • ?

      Establish key communication points in national competent authorities and build a resource of
      key messages and communication materials on regulation and methodology.

    • The timing of workshops may need to be arranged according to the

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 13/14

      specific needs of the guidance ? either before the guidance is finalised to gather views and
      expertise; or once it is finalised for training purposes.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 14/14

Nomi Health Announces Advisory Board to Guide Integrated Care Programs, Closing Most Care Gaps for Providers and Plans

Retrieved on: 
Tuesday, February 13, 2024
Mental Health, Technology, Electronic Commerce, General Health, Professional Services, Public Policy, Government, Payments, Health, Health Technology, Health Insurance, White House, Federal Government, State, Local, Software, Social Services, Insurance, Practice Management, Fintech, Public policy, Mental health, HEDIS, Friction, Assistant, MD, Drug, Suds, Global health, Partner, Quality assurance, Medicare, Population health, Policy, Health policy, Infection, NCQA, Medicaid, National Committee, Epidemiology, Public, Nursing

Nomi Health announced the formation of an advisory board composed of top policy, executive, medical and legal experts to guide and advise on the development of solutions for its customers, including providers, self-funded employers, governments and their partners.

Key Points: 
  • Nomi Health announced the formation of an advisory board composed of top policy, executive, medical and legal experts to guide and advise on the development of solutions for its customers, including providers, self-funded employers, governments and their partners.
  • Specifically, Nomi’s Integrated Programs give providers and health plans, through a whole-person approach, an end-to-end infrastructure that identifies, closes and monitors gaps in care for populations in need of specific care.
  • His expertise includes population health, value-based payment, social determinants of health and quality measurement.
  • “We are putting the advisory board to work immediately in our program focused on serious issues threatening communities nationwide today.

Chagas Disease (T. cruzi Infection) Market: Comprehensive Global Analysis and Forecast Through 2028 - ResearchAndMarkets.com

Retrieved on: 
Monday, February 12, 2024
Infectious Diseases, Pharmaceutical, Health, Pharmacy, Intelligence, Chagas disease, FDA, Infection, Epidemiology, ESG, Hospital, Health care, Bayer, Child, CDC, Movement, Trypanosoma cruzi, Research report, Nifurtimox, Vaccine

The protozoan Trypanosoma cruzi is the cause of Chagas disease (CD), also known as American trypanosomiasis, a chronic, systemic, parasitic illness with substantial risk factors associated with low socioeconomic status.

Key Points: 
  • The protozoan Trypanosoma cruzi is the cause of Chagas disease (CD), also known as American trypanosomiasis, a chronic, systemic, parasitic illness with substantial risk factors associated with low socioeconomic status.
  • It is widespread throughout 21 American countries, but it can spread to non-endemic nations worldwide through the movement of infected individuals.
  • The research report provides a thorough overview of the Chagas Disease market.
  • This report analyzes CD market trends with epidemiological and regional markets, highlights the current market and offers a detailed competitive environment analysis.

Novotech Publishes Candidiasis and Rheumatoid Arthritis Clinical Trial Landscape Reports to Support Biotech Research Planning

Retrieved on: 
Monday, February 12, 2024
Therapy, Woman, Compound annual growth rate, Gene editing, Rheumatoid arthritis, APA, MicroRNA, Research, Investment, Molecular medicine, Candida albicans, Epidemiology, Geography, Death, Prevalence, Lead, Contract research organization, Joint, Organization, SWOT analysis, Optimism, Clinical trial, Diagnosis, Fungal infection, Disease-modifying antirheumatic drug, Pharmaceutical industry

The Novotech research analyst team provides these expert reports on a monthly basis, completely free of charge.

Key Points: 
  • The Novotech research analyst team provides these expert reports on a monthly basis, completely free of charge.
  • These reports offer current insights into global clinical trial activity, revealing which regions experience the highest trial volumes and the factors behind these trends.
  • The Rheumatoid Arthritis (RA)– Global Clinical Trial Landscape report looks at the prevalence globally and identifies the key factors driving this condition.
  • Overall, this report provides vital insights into the global clinical trial landscape, detailing ongoing developments in RA research.

EQS-News: Abivax appoints Ana Sharma as Vice President, Global Head of Quality

Retrieved on: 
Wednesday, February 7, 2024
Biostatistics, Research, Novartis, GxP, Therapy, Gastroenterology, Patient, Patient safety, Boston University, Public health, Euronext Paris, Epidemiology, Dana–Farber Cancer Institute, Amgen, Management

Abivax appoints Ana Sharma as Vice President, Global Head of Quality

Key Points: 
  • Abivax appoints Ana Sharma as Vice President, Global Head of Quality
    The issuer is solely responsible for the content of this announcement.
  • Abivax appoints Ana Sharma as Vice President, Global Head of Quality
    PARIS, France, February 7, 2024, 8:30 a.m. CET – Abivax SA (Euronext Paris and Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced the appointment of Ana Sharma as Vice President, Global Head of Quality.
  • Ms. Sharma brings over 20 years of experience in the biopharmaceutical industry and has a strong track record in quality and GxP compliance.
  • If approved, it would be available to many patients who are in need of safe and long-term efficacious therapeutic options for chronic inflammatory diseases.”
    Ana Sharma joined Abivax from Takeda, where she held the position of Vice President, Global Head of Research and Development Clinical Quality Assurance.

Abivax appoints Ana Sharma as Vice President, Global Head of Quality

Retrieved on: 
Wednesday, February 7, 2024
Biostatistics, Research, Novartis, GxP, Therapy, Gastroenterology, Patient, Patient safety, Boston University, Public health, Euronext Paris, Epidemiology, Dana–Farber Cancer Institute, Amgen

Abivax appoints Ana Sharma as Vice President, Global Head of Quality

Key Points: 
  • Abivax appoints Ana Sharma as Vice President, Global Head of Quality
    PARIS, France, February 7, 2024, 8:30 a.m. CET – Abivax SA (Euronext Paris and Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced the appointment of Ana Sharma as Vice President, Global Head of Quality.
  • Ms. Sharma brings over 20 years of experience in the biopharmaceutical industry and has a strong track record in quality and GxP compliance.
  • Marc de Garidel, Chief Executive Officer of Abivax, says: “I am glad Ana joins our team with her extensive experience in research and development quality assurance in the biopharmaceutical sector.
  • If approved, it would be available to many patients who are in need of safe and long-term efficacious therapeutic options for chronic inflammatory diseases.”
    Ana Sharma joined Abivax from Takeda, where she held the position of Vice President, Global Head of Research and Development Clinical Quality Assurance.

PHYSICIAN-SCIENTISTS UNDERREPRESENTED IN MEDICINE TO CONDUCT HEALTH EQUITY RESEARCH AT MONTEFIORE AND EINSTEIN

Retrieved on: 
Tuesday, February 6, 2024
Mortality, Hospital, Research, Obesity, Emotional intelligence, Montefiore Medical Center, HIV/AIDS, Pediatrics, Albert Einstein, Blood, Infant, Lung, Diversity, Epidemiology, National Institutes of Health, Sleep, Inclusion, Diabetes, Bangladesh Technical Education Board, Medicine, Health, Asthma, Montefiore, T32, Nursing

NEW YORK, Feb. 6, 2024 /PRNewswire/ -- Montefiore Health System and Albert Einstein College of Medicine have been awarded a $1.5 million National Institutes of Health grant to provide advanced research training to post-graduate trainees from groups that are underrepresented in medicine and have research interests in heart, lung, blood, and sleep disorders. Over five years, nine researchers will receive intense research training and robust mentorship from almost 30 established, senior investigators across Montefiore and Einstein.

Key Points: 
  • Over five years, nine researchers will receive intense research training and robust mentorship from almost 30 established, senior investigators across Montefiore and Einstein.
  • , principal investigator, vice chair for clinical and community-based research at the Children's Hospital at Montefiore and professor of pediatrics at Albert Einstein College of Medicine .
  • The research projects conducted by the nine investigators will aim to understand and reduce these inequities.
  • The T32 Training Program is titled "Purposeful Outreach for Diversity and Inclusion of Underrepresented in Medicine (PODIUM) Physician-Scientists" (1T32HL172255-01) and is intended to support training of postdoctoral trainees at Montefiore and Einstein, institutions uniquely positioned to engage minority and other health disparity populations in research, translation, and implementation of research advances that impact health outcomes, as well as provide health care for these populations.