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Found 248 articles

  • Survodutide Phase II trial shows 83% of adults tre

    Survodutide Phase II trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis

    • 27 Feb 2024
    • Editor

    Boehringer Ingelheim today announced that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase II trial [response difference: 64.8% (CI 51.1% - 78.6%), p<0.0001].2

  • GSK announces positive headline results from EAGLE

    GSK announces positive headline results from EAGLE-1 phase III trial for gepotidacin in uncomplicated urogenital gonorrhoea (GC)

    • 27 Feb 2024
    • Editor

    GSK plc (LSE/NYSE: GSK) today announced positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea in adolescents and adults.

  • Innovative Trials unveils initiative to boost clin

    Innovative Trials unveils initiative to boost clinical trial patient retention in pediatric studies

    • 21 Feb 2024
    • Editor

    A new initiative designed to boost clinical trial patient retention in pediatric studies has been announced today (19 February) by Innovative Trials, global specialists in clinical trial patient recruitment and retention acceleration.

  • BiVACOR® Receives $13 Million to Support Clinical

    BiVACOR® Receives $13 Million to Support Clinical Trials for the Company’s Total Artificial Heart

    • 21 Feb 2024
    • Editor

    BiVACOR®, a clinical-stage medical device company, today announced $13 million (USD) awarded from the Australian Government’s Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP) to support BiVACOR’s Total Artificial Heart program and future product enhancements.

  • IQVIA Named to Fortune® World's Most Admired Compa

    IQVIA Named to Fortune® World's Most Admired Companies™ List, Ranked #1 in Its Sector for the Third Consecutive Year

    • 7 Feb 2024
    • Editor

    IQVIA™ (NYSE:IQV), a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, has been named to the Fortune® World's Most Admired Companies™ list for the seventh consecutive year.

  • Parexel Appoints Susan R. Salka to Board of Direct

    Parexel Appoints Susan R. Salka to Board of Directors

    • 2 Feb 2024
    • Editor

    Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, today announced the appointment of Susan R. Salka, retired Chief Executive Officer and President of AMN Healthcare Services, Inc., to its Board of Directors. Ms. Salka’s appointment is effective Feb. 1.

  • Merck’s KEYTRUDA® (pembrolizumab) Significantly Im

    Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Disease-Free Survival (DFS) as Adjuvant Therapy Versus Observation in High-Risk Patients With Localized Muscle-Invasive and Locally Advanced Urothelial Carcinoma After Surgery

    • 29 Jan 2024

    Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of high-risk patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced resectable urothelial carcinoma.

  • Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk

    Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Death by 38% Versus Placebo as Adjuvant Therapy for Patients With Renal Cell Carcinoma (RCC) at an Increased Risk of Recurrence Following Nephrectomy

    • 29 Jan 2024
    • Editor

    Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

  • Subcutaneous Nivolumab (nivolumab and hyaluronidas

    Subcutaneous Nivolumab (nivolumab and hyaluronidase) Shows Noninferiority Compared to Intravenous Opdivo (nivolumab) in Advanced or Metastatic Clear Cell Renal Cell Carcinoma in CheckMate -67T Trial

    • 29 Jan 2024
    • Editor

    Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC).

  • Bristol Myers Squibb Receives Positive CHMP Opinio

    Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel)in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

    • 29 Jan 2024
    • Editor

    Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization approval of Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.

  • Positive Phase 1/2 Clinical Trial Data for an Inve

    Positive Phase 1/2 Clinical Trial Data for an Investigational Gene Therapy for Genetic Hearing Loss to be Presented at the Association for Research in Otolaryngology 2024 MidWinter Meeting

    • 24 Jan 2024
    • Editor

    Akouos, Inc., a wholly owned subsidiary of Eli Lilly and Company (NYSE: LLY), today announced positive initial clinical results from the Phase 1/2 AK-OTOF-101 study, which demonstrated pharmacologic hearing restoration within 30 days of AK-OTOF administration in the first participant, an individual with a decade-plus history of profound hearing loss.

  • Biotech companies to increase R&D spend but highli

    Biotech companies to increase R&D spend but highlight complexity of clinical trials - ICON

    • 9 Jan 2024
    • Editor

    ICON plc, (NASDAQ: ICLR) a world-leading healthcare intelligence and clinical research organisation, today launched its “Optimising biotech funding” whitepaper. This provides an overview of the current state of play for biotech companies and the research and development (R&D) strategies they can adopt to attract and best utilise investment funding.

  • Immutep Receives Constructive Regulatory Feedback

    Immutep Receives Constructive Regulatory Feedback on TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

    • 22 Dec 2023
    • Editor

    Immutep Limited today announces constructive feedback has been received from the Paul-Ehrlich-Institut (“PEI”), a German regulatory authority and part of the Committee for Medicinal Products for Human Use (CHMP), regarding the planned TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (NSCLC).

  • Thermo Fisher Scientific’s PPD Clinical Research B

    Thermo Fisher Scientific’s PPD Clinical Research Business Selected by BARDA to Support Phase II Platform Clinical Trial to Treat Acute Respiratory Distress Syndrome (ARDS)

    • 22 Dec 2023
    • Editor

    The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been selected by the Biomedical Advanced Research and Development Authority (BARDA) to implement the first BARDA-supported Phase II platform clinical trial to investigate multiple therapeutic options for the treatment of acute respiratory distress syndrome (ARDS).

  • Levicept Completes Recruitment in Phase II Clinica
  • WuXi Vaccines Wins Second Consecutive “Best Vaccin

    WuXi Vaccines Wins Second Consecutive “Best Vaccine CMO Award” at AVEA 2023

    • 13 Dec 2023
    • PharmiWeb Editor

    WuXi Vaccines, a leading global vaccine Contract Development and Manufacturing Organization (CDMO), was named "Best Vaccine CMO of the Year" for the second consecutive year at the 2023 Asia-Pacific Vaccine Excellence Awards (AVEA) ceremony

  • Yseop Announces Strategic Investment and Celebrate

    Yseop Announces Strategic Investment and Celebrates Milestone of 150 Clinical Trials Powered by Generative AI

    • 7 Dec 2023
    • PharmiWeb Editor

    Yseop, a world-leading Generative AI company for life sciences, today announces the closing of a strategic investment round, with new investor Novartis (dRx Capital),...

  • Lilly to Present Final Overall Survival Analysis f

    Lilly to Present Final Overall Survival Analysis from the MONARCH 3 Study of Verzenio® (abemaciclib) and Additional Results from Its Breast Cancer Portfolio at the 2023 San Antonio Breast Cancer Symposium

    • 6 Dec 2023
    • Editor

    Eli Lilly and Company (NYSE: LLY) today announced results from the MONARCH 3 clinical trial, which will be presented in a late-breaking presentation during the 2023 San Antonio Breast Cancer Symposium (SABCS).

  • Roche announces positive Phase III results for ina

    Roche announces positive Phase III results for inavolisib combination in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

    • 5 Dec 2023
    • Editor

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance®) and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer.

  • Immutep Announces Site Expansion for INSIGHT-003 P

    Immutep Announces Site Expansion for INSIGHT-003 Phase I Trial

    • 23 Nov 2023
    • Editor

    Immutep (Formerly known as Prima Biomed) Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the INSIGHT-003 trial has been expanded to four sites across Germany including the University Clinic of Ruhr Universität Bochum and the Lung Clinic Cologne-Merheim.