News and Press Releases

ASH: Sarclisa combinations demonstrated significant benefits in newly diagnosed multiple myeloma patients

New analysis from the IMROZ phase 3 study of Sarclisa-VRd demonstrated higher and sustained MRD negativity rates in transplant-ineligible NDMM patients versus VRd alone New detailed results from the GMMG-HD7...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 9, 2024

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DARZALEX® (daratumumab) subcutaneous formulation shows 51 percent reduction in risk of progression to active multiple myeloma for patients with high-risk smouldering multiple myeloma

First subcutaneous anti-CD38 therapy to demonstrate potential to prevent end-organ damage, and extendprogression-free survival and overall survival based on findings from Phase 3 AQUILA study 8 December 2024 – BEERSE,...

Category: Clinical Trials
Posted: December 9, 2024

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Puma Biotechnology Announces Initiation of ALISCATM-Breast1 Phase II Trial of Alisertib in Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer

20 November 2024 -- California, US -- Puma Biotechnology, Inc, a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCATM-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 20, 2024

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CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer

The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations...

Category: Clinical Trials
Posted: November 20, 2024

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Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO®/DARZALEX® (daratumumab) as subcutaneous monotherapy for high-risk smouldering multiple myeloma

If approved, daratumumab will become the first treatment option for patients with smouldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: November 8, 2024

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Galapagos to Present Results of Pioneering Innovation in Cancer Cell Therapy at ASH 2024 

New Phase 1/2 data support the potential of our CAR T-cell therapy candidates, GLPG5101 and GLPG5201, in addressing unmet needs for patients with poor prognoses Our innovative decentralized cell therapy...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 5, 2024

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Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer

If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant...

Category: Clinical Trials, Drug Discovery
Posted: October 24, 2024

DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible

Phase 3 PERSEUS study of daratumumab subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone induction and consolidation, followed by daratumumab SC and lenalidomide maintenance showed a 58 percent...

Category: Drug Discovery
Posted: October 23, 2024

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STERILINE ASIA IS RETURNING TO CPHI & PMEC INDIA, FOCUSING ON TECHNLOGY AND PROCESS ADVANCEMENTS FOR THE LOCAL MARKET

The “Quality by Design” approach and close collaboration with regulatory bodies drive sustainable innovation in a fast-paced market 21 October 2024 – Delhi, India – Steriline Asia, the Indian subsidiary...

Category: Manufacturing and Packing
Posted: October 21, 2024

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Publication Demonstrates Potential for Multi-Marker CTC Profiling in Early Prostate Cancer

Parsortix enriched CTCs detected at high rates in localised disease Multi-marker profiling of CTCs could support development of targeted therapies and help stratify patients in clinical trials 17 October 2024...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 17, 2024

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HUTCHMED Announces that TAGRISSO plus ORPATHYS demonstrated high,clinically meaningful response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial

New data demonstrate efficacy for the oral treatment combination to address MET-driven resistance in EGFR-mutated lung cancer MET is a common biomarker in this setting for patients who develop resistance...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 16, 2024

Nipocalimab demonstrates sustained disease control in adolescents living with generalised myasthenia gravis in the Phase 2/3 study

First FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adolescents aged 12 – 17 years, broadening the population in which nipocalimab has been studied 15...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 15, 2024

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Mosaic Therapeutics appoints Dr Barry Davies as CSO

Former AstraZeneca Senior Director, Global Project Leader adds significant experience and expertise to leadership team Appointment will drive further development of Mosaic’s targeted oncology combination therapies pipeline and platform. 7...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 7, 2024

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Scotland first in the UK to recommend a new treatment option for lung cancer, which could help lower the risk of cancer returning

7 October 2024 -- Scotland, UK -- the Scottish Medicines Consortium has recommended MSD's KEYTRUDA® (pembrolizumab) as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma (NSCLC)...

Category: Other, Pharmaceutical
Posted: October 7, 2024

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CARVYKTI® ▼ (ciltacabtagene autoleucel; cilta-cel) is the first cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line

45 percent reduction in risk of death achieved with cilta-cel versus standard therapies after threeyear follow-up in landmark CARTITUDE-4 study Data featured in a late-breaking oral presentation at the 2024...

Category:
Posted: October 1, 2024

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