Search Results for “Clinical Trial” – Page 22 – media

GSK tees up AstraZeneca rivalry with positive Jemperli-Zejula readout in endometrial cancer

On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. This time, the company is touting results for its PD-1 inhibitor Jemperli and PARP inhibitor Zejula, which could become a threat to a rival therapy at AstraZeneca. Adding Jemperli and Zejula to chemotherapy significantly extended the time before tumor progression or death in patients with primary advanced or recurrent endometrial cancer that’s mismatch repair proficient or microsatellite stable (pMMR/MSS), GSK said Monday. The results came from the second part of the phase 3 RUBY trial. The trial also showed that the Jemperli-Zejula-chemo regimen was better at delaying disease worsening than chemo alone in the overall population, regardless of genetic stability. But GSK appears to think that the combo has more value in the pMMR/MSS subgroup. Patients with pMMR/MSS endometrial cancer have few treatment options, Hesham Abdullah, GSK’s head of oncology R&D, said in ...
- Source: drugdu
- 190
- December 20, 2023
J&J’s Biosense Webster treats first patients in dual-energy AFib ablation trial

BY SEAN WHOOLEY The ThermoCool SmartTouch dual-energy ablation catheter could offer a treatment option for AFib. [Image courtesy of Biosense Webster]Johnson & Johnson’s Biosense Webster today announced the first completed patient cases in a study of its dual-energy ablation catheter. Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib. AFib ablation has become a hotbed for innovation in recent years. Medtronic stands as one competitor after its $1 billion Affera acquisition, plus the FDA yesterday approved its PulseSelect PFA system for treating AFib. Boston Scientific and its Farapulse system represent another exciting option in the space. The company expects FDA approval sometime next year. Dr. David Newton of Memorial Health University Physicians Heart Care and Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, performed ...
- Source: drugdu
- 584
- December 18, 2023
Fosun Pharma’s Global Multicenter Phase III Clinical Program for New Anti-malarial Drugs Receives USD 3.3 Million Investment from GHIT Fund Jointly Enhancing Global Accessibility of Anti-malarial Drugs

(Shanghai, China, December 14, 2023) Japan’s Global Health Innovative Technology Fund (GHIT Fund) announced today that it will invest approximately US$3.3 million (approximately 500 million yen) in a global multicenter Phase III clinical trial project in Africa and Southeast Asia for a new anti-malarial drug, artemether benfluorex amodiaquine triple combination formulation, led by Fosun Pharmaceuticals (“the project “) invests approximately US$3.3 million (approximately JPY500 million1 ) to advance the development and launch of this new drug. The Project will be jointly conducted by Fosun Pharma, Marubeni Corporation of Japan, the Mahidol-Oxford Research Center for Tropical Medicine in Thailand, a division of the University of Oxford (“MORU”), and the Medicines for Malaria Foundation (“MMV”), and this is the first time that the GHIT Fund has invested in a research project led by a According to GHIT, the drug candidate could address the widespread Plasmodium artemisinin partial resistance (ART-R) problem in the ...
- Source: drugdu
- 99
- December 17, 2023
Gracell Biotechnologies Presents Updated Clinical Data from FasTCAR-T GC012F Demonstrating Deep and Durable Responses in Newly Diagnosed Multiple Myeloma at ASH 2023

Minimal residual disease negativity (MRD-) observed in all treated patients in the ongoing study, with 95% (21/22) achieving stringent complete response (sCR) through a median follow-up of 18.8 months GC012F is a FasTCAR-enabled B-cell maturation antigen (BCMA) and CD19 dual-targeting autologous CAR-T therapy being evaluated for hematologic malignancies and autoimmune disease SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 11, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today presented updated results from the clinical investigator-initiated trial (IIT) of GC012F for treatment of newly diagnosed multiple myeloma (NDMM) as an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place in San Diego, California and online. GC012F demonstrated a 100% overall response rate (ORR) and 95% ...
- Source: drugdu
- 149
- December 15, 2023
Merck and Moderna to Launch Trial of mRNA-4157 Plus Keytruda in Non-Small Cell Lung Cancer

Pharmaceutical Executive Editorial Staff Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer. Image credit: Axel Kock | stock.adobe.com Merck and Moderna, Inc., have announced plans to launch the pivotal Phase III INTerpath-002 (NCT06077760) clinical trial of the novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). V940 is comprised of synthetic mRNA coding for up to 34 neoantigens that are designed and produced based on the unique mutational signature of a patient’s tumor. After administration of the drug, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation. “As lung cancer is the leading cause ...
- Source: drugdu
- 95
- December 13, 2023
Lilly’s Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing

As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. On Friday, Dec.1, the FDA granted accelerated approval to Lilly’s Jaypirca for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. Jaypirca, which is itself a BTK inhibitor, is now allowed following treatment with a BTK inhibitor and a BCL-2 inhibitor. The ability to help patients who have failed on a BTK inhibitor makes Jaypirca unique. The Lilly med is a non-covalent BTK inhibitor that binds to BTK by a mechanism different from existing covalent agents, namely AbbVie/J&J’s Imbruvica, AZ’s Calquence and BeiGene’s Brukinsa. “Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be ...
- Source: drugdu
- 95
- December 6, 2023
EU’s IVD guidelines continue affecting early clinical work

The implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Union (EU) continues to be a disadvantage for companies looking to start their clinical trials in the EU, said Malte Oppermann, senior director of clinical operations at Medigene. Oppermann spoke at a session of the Clinical Trials in Oncology (CTO) Europe 2023 conference in Munich, Germany, which took place 28 – 29 November. The session focused on the impact of IVD regulation changes on early-stage clinical trials and the challenges that come with clinical trials that incorporate IVDs. In a nutshell, IVDs are tests carried out on patient samples that can be used to prevent and treat diseases. In oncology, IVDs are used to detect biomarkers, which have become increasingly important in precision medicine. Examples of established biomarkers with approved therapies include the prognostic biomarkers HER2 and BRCA1. The IVDR came into effect on 26 May ...
- Source: drugdu
- 95
- December 4, 2023
Phase 3 Trial for GSK’s Blenrep Yields Positive Results in Relapsed or Refractory Multiple Myeloma

Don Tracy, Associate Editor Blenrep significantly extended the time to disease progression or death against existing care methods as a second-line treatment for relapsed or refractory multiple myeloma. GSK announced positive results from an interim analysis of its DREAMM-7 head-to-head Phase 3 trial evaluating belantamab mafodotin (Blenrep) as a second-line treatment for relapsed or refractory multiple myeloma. According to a company press release, the trial met its primary endpoint of progression-free survival (PFS) and showed that Blenrep when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma.1 “Patients with multiple myeloma need treatment options after first relapse that are efficacious, readily accessible and have novel mechanisms of action,” said Hesham Abdullah, SVP, global head, oncology, R&D, GSK, in a press release.1 “We are particularly encouraged by the potential for belantamab mafodotin ...
- Source: drugdu
- 102
- December 2, 2023
Bayer’s stock drops to new 18-year low after asundexian trial termination

Bayer’s stock price has plummeted to its lowest since 2005 after a clinical trial investigating the anti-coagulant drug asundexian was stopped early due to lack of efficacy. The Phase III OCEANIC-AF trial (NCT05643573) aimed to determine asundexian’s use as a treatment for people living with atrial fibrillation in a bid to prevent strokes or systemic embolisms. The Independent Data Monitoring Committee (IDMC) found that asundexian was inferior in terms of efficacy when compared to the control arm of the trial. The OCEAN-AF trial was a part of the overall OCEAN Phase III programme. However, the committee recommended continuing another Phase III OCEANIC-STROKE trial (NCT05686070) examining the use of the drug in stroke patients. Following the announcement on 19 November 2023, the German pharmaceutical firm’s stock value dropped from €41.45 ($45.38) per share down to €30.77 ($33.68), as of 28 November. It is the lowest price in 18 years. The last ...
- Source: drugdu
- 107
- November 30, 2023
Acelyrin claims errors by CRO Fortrea led to late-stage trial downfall

Immunology biotech Acelyrin has determined that its CRO partner Fortrea is responsible for the late-stage failure of its immunotherapeutic drug candidate for moderate to severe hidradenitis suppurativa (HS). The company says a programming blunder by a vendor recruited by the CRO resulted in two erroneously treated patient arms going undetected through the testing processes. Los Angeles-based Acelyrin was aiming to make waves in a fiercely competitive psoriasis market with a breakout $540m IPO in May and a steady stream of clinical data and patient enrolment updates on its izokibep clinical program. But in September, when the Phase IIb/III study (NCT05355805) failed to meet its endpoint of achieving a 75% reduction in total abscesses and inflammatory nodules, the company’s stock more than halved overnight and has not yet recovered to the levels seen before 11 September. While a press release issued by Acelyrin outlining the error did not identify Fortrea as ...
- Source: drugdu
- 232
- November 30, 2023

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