News and Press Releases
Novo Nordisk to present new data from sickle cell disease and haemophilia trials at the 66th American Society of Hematology (ASH) annual meeting
HIBISCUS phase 2 data evaluating the safety profile and efficacy of etavopivat in adult and adolescent patients with sickle cell disease FRONTIER4 interim phase 3 results evaluating safety profile and...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 3, 2024
HUTCHMED and Innovent Jointly Announce NMPA Conditional Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Advanced Endometrial Cancer
First regulatory approval for fruquintinib combination therapy with an immune checkpoint inhibitor 3 December 2024 -- Hong Kong, Shanghai and New Jersey, US — HUTCHMED (China) and Innovent Biologics, Inc...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 3, 2024
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
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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Barinthus Bio Announces Results From Ongoing Phase 2b Chronic Hepatitis B Trial, Including Achievement of Functional Cure and HBsAb Seroconversion
Eight participants achieved HBsAg loss at any time Two participants met criteria for functional cure Two participants who discontinued NUC therapy seroconverted to HBsAb positivity. 15 November 2024 -- Oxford,...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: November 15, 2024
French Biotech Company AdipoPharma Secures Funding to Initiate Clinical Trials for its first-in-class compound for Insulin Resistance
Global Investments Pave Way for Breakthrough Treatment for Type 2 Diabetes 11 November 2024 -- Strasbourg, France -- AdipoPharma, a biotech company headquartered in France with offices in the US...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 11, 2024
MMS Named a Finalist in the 2024 Fierce CRO Awards for Leadership in Regulatory Compliance
Zero refusals to file and a SOUL mindset helped solidify the honor 8 November 2024 -- Michigan, US -- MMS, a leading data and regulatory focused clinical research organization (CRO),...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 8, 2024
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
NorthWest EHealth (NWEH) announces a pilot to test a new model for finding and recruiting participants for clinical trials using the Clinical Practice Research Datalink
The pilot aims to speed up the process for safely and securely finding participants for UK clinical trials, improving efficiencies and opportunities for people to take part in research and...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 5, 2024
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Loftware and Signant Health Announce Availability of Integrated Clinical Supplies Labeling Solution
Automates to improve speed, enable compliance, and support scalability 31 October 2024 -- New Hampshire, US -- Loftware, the global leader in Enterprise Labeling and Artwork Management solutions, and Signant Health, the leader in...
Category: Clinical Trials, Logistics, Manufacturing and Packing, Pharmaceutical
Posted: October 31, 2024
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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BioPharma Industry Excited about the early use of AI in clinical trials
Experts discuss the long road for complete AI-led transformation at Indegene Digital Summit 202421 October 2024 -- New Jersey, US, and London, UK -- Clinical development experts from Novartis, GSK,...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 21, 2024
SciRhom Initiates Dosing in First-in-Man Clinical Study Evaluating the Company’s Lead Development Program SR-878
Transition into clinical-stage development marks a significant corporate and R&D milestone 17 October 2024 -- Munich, Germany -- SciRhom GmbH, a biopharmaceutical company pioneering the development of first-in-class therapeutic iRhom2...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 17, 2024
