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Found 248 articles

  • GSK announces major step towards sustainability am

    GSK announces major step towards sustainability ambitions with advancement of low carbon Ventolin programme to Phase III trials

    • 21 Nov 2023
    • Editor

    GSK plc (LSE/NYSE: GSK) today announced it will start Phase III trials of a low carbon version of its metered dose inhaler (MDI), Ventolin (salbutamol), using a next generation propellant, in 2024.

  • UK industry clinical trial performance shows signs

    UK industry clinical trial performance shows signs of improvement, says ABPI report

    • 17 Nov 2023
    • Editor

    The decline in the number of industry clinical trials initiated in the UK shows welcome early signs of recovery. However, progress is not yet enough to restore the UK’s global ranking on trials.

  • Tigerlily Foundation and Labcorp Launch I AM INCLU

    Tigerlily Foundation and Labcorp Launch I AM INCLUDED Framework to Increase Clinical Trial Diversity, Accelerate Delivery of Innovative Cancer Treatments

    • 17 Nov 2023
    • Editor

    Today, the Tigerlily Foundation (Tigerlily), a leading breast cancer patient advocacy organization, and Labcorp, a global leader of innovative and comprehensive laboratory services, announced the launch of I AM INCLUDED, a co-developed, modernized, multi-stakeholder framework for sharing best practices of U.S. diverse clinical trial site leaders for inclusive cancer clinical trials.

  • Truqap (capivasertib) plus Faslodex approved in th

    Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer

    • 17 Nov 2023
    • Editor

    AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN).

  • Results Published in The Lancet Show UBRELVY® (ubr

    Results Published in The Lancet Show UBRELVY® (ubrogepant) Reduces the Headache Phase of a Migraine Attack When Dosed During the Prodrome of Migraine

    • 17 Nov 2023
    • Editor

    AbbVie (NYSE: ABBV) today announced detailed results published in The Lancet evaluating the efficacy, safety, and tolerability of UBRELVY® (ubrogepant) 100 mg for the acute treatment of migraine when administered during the prodrome of a migraine attack.

  • FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plu

    FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

    • 17 Nov 2023
    • Editor

    Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy.

  • Certa Therapeutics presents positive data from a P

    Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma

    • 16 Nov 2023
    • Editor

    Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, announces the presentation of results of its Phase 2 clinical trial of FT011 in patients with scleroderma at ACR Convergence 2023, the annual scientific meeting of the American College of Rheumatology being held in San Diego, California (10 – 15 November 2023).

  • Update on PACIFIC-2 Phase III trial of Imfinzi con

    Update on PACIFIC-2 Phase III trial of Imfinzi concurrently administered with platinum-based chemoradiotherapy in unresectable, Stage III non-small cell lung cancer

    • 14 Nov 2023
    • Editor

    The PACIFIC-2 Phase III trial for Imfinzi (durvalumab) concurrently administered with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of progression-free survival (PFS) versus CRT alone for the treatment of patients with unresectable, Stage III non-small cell lung cancer (NSCLC).

  • New Real-World Data Show TREMFYA® (guselkumab) Was

    New Real-World Data Show TREMFYA® (guselkumab) Was Associated With Clinically Meaningful Improvements in Patient-Reported Outcomes for Adults Living With Active Psoriatic Arthritis

    • 9 Nov 2023
    • Editor

    Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, today announced new data from the CorEvitas Psoriatic Arthritis (PsA) and Spondyloarthritis Registry that showed a substantial proportion of people living with treatment-resistant active PsA and using TREMFYA® (guselkumab) in real-world settings reported meaningful improvements in pain, physical function and fatigue through six months.

  • Imfinzi plus bevacizumab met primary endpoint for

    Imfinzi plus bevacizumab met primary endpoint for progression-free survival in liver cancer eligible for embolisation in EMERALD-1 Phase III trial

    • 9 Nov 2023
    • Editor

    Positive high-level results from the EMERALD-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with transarterial chemoembolisation (TACE) and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolisation.

  • AdvanCell Announces First Patient Dosed in Phase I

    AdvanCell Announces First Patient Dosed in Phase I/II TheraPb Clinical Trial of 212Pb-ADVC001 in Metastatic Prostate Cancer

    • 8 Nov 2023
    • Editor

    AdvanCell, a radiopharmaceutical company developing a pipeline of Targeted Alpha Therapies for cancer patients, today announced the first patient was treated with 212Pb-ADVC001, a Targeted Alpha Therapy in development for the treatment of PSMA-positive metastatic CastrationResistant Prostate Cancer (mCRPC).

  • Gilead and Arcus Announce New Data Showing Encoura

    Gilead and Arcus Announce New Data Showing Encouraging Clinical Activity of Anti-TIGIT Domvanalimab-Containing Regimen as First-line Treatment for Upper GI Cancers

    • 7 Nov 2023
    • Editor

    Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced that domvanalimab plus zimberelimab and chemotherapy showed encouraging overall response rate (ORR) and six-month progression-free survival (PFS) rate results in a preliminary analysis from Arm A1 of the EDGE-Gastric study.

  • Immutep Announces Completion of the Safety Lead-In

    Immutep Announces Completion of the Safety Lead-In and Opening of the Randomized Phase II of the AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer

    • 7 Nov 2023
    • Editor

    Immutep 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 the open-label safety lead-in of its integrated AIPAC-003 Phase II/III trial evaluating for the very first time 90mg of eftilagimod alpha (efti) in combination with paclitaxel has been completed with no safety or tolerability issues.

  • Syneos Health Signs Agreement with P3 Research Ltd

    Syneos Health Signs Agreement with P3 Research Ltd Network to Support Clinical Trials in New Zealand

    • 6 Nov 2023
    • Editor

    Syneos Health®, a leading fully integrated biopharmaceutical solutions organization, has signed an agreement with P3 Research Ltd Network. The agreement further expands the Company’s clinical trial capabilities across a broader range of therapeutic areas in New Zealand (NZ).

  • Chimeric Therapeutics Announces FDA Clearance of I

    Chimeric Therapeutics Announces FDA Clearance of IND Application for CHM 2101, a Novel CDH17 CAR T Cell Therapy for Advanced Gastrointestinal Cancers

    • 1 Nov 2023
    • Editor

    Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), an Australian leader in cell therapy, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of CHM 2101, Chimeric's first in class CDH17 CAR T cell therapy for gastrointestinal cancers.

  • LEO Pharma announces positive outcome of DELTA 3 o

    LEO Pharma announces positive outcome of DELTA 3 open-label extension trial of delgocitinib cream in the treatment of adults with moderate to severe chronic hand eczema (CHE)

    • 31 Oct 2023
    • PharmiWeb Editor

    LEO Pharma's DELTA 3 trial on delgocitinib cream for chronic hand eczema (CHE) shows positive long-term safety & efficacy. Continuity in symptom relief and treatment success observed for up to 36 weeks, promising for CHE patients.

  • European Medicines Agency Validates Bristol Myers

    European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

    • 31 Oct 2023
    • Editor

    Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial.

  • Phase III RUBY trial of Jemperli (dostarlimab) plu

    Phase III RUBY trial of Jemperli (dostarlimab) plus chemotherapy meets endpoint of overall survival in patients with primary advanced or recurrent endometrial cancer

    • 30 Oct 2023
    • Editor

    GSK plc (LSE/NYSE: GSK) today announced positive headline results from a planned analysis of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin and paclitaxel), followed by dostarlimab as a single agent, compared to placebo plus chemotherapy followed by placebo in adult patients with primary advanced or recurrent endometrial cancer.

  • Clarity and PSI kick off SAR-bisPSMA Phase III

    Clarity and PSI kick off SAR-bisPSMA Phase III

    • 27 Oct 2023
    • Editor

    Clarity Pharmaceuticals and PSI CRO AG (“PSI”) have entered into an agreement and have commenced work towards Clarity’s Phase III diagnostic trial of SAR-bisPSMA in prostate cancer participants, CLARIFY (NCT06056830)1.

  • Moderna Announces First Participant Dosed in Phase

    Moderna Announces First Participant Dosed in Phase 3 Study of mRNA-1083, a Combination Vaccine Against Influenza and COVID-19

    • 25 Oct 2023
    • Editor

    Moderna, Inc. (NASDAQ:MRNA) today announced that the first participant has been dosed in a Phase 3 study of the Company's combination vaccine candidate against influenza and COVID-19 (mRNA-1083) in the U.S. The trial is expected to enroll approximately 8,000 adults in the Northern Hemisphere.