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Gerresheimer Presents its New Clinical Trial Kit to Accelerate Drug Development February 1, 2023
Gerresheimer presents its new Clinical Trial Kit at Pharmapack in Paris. This kit consists of sterile Gx RTF vials in...SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector January 17, 2023
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
CLINICAL TRIALS - Historical Controls in Rare Disease Drug Development: Using RWE to Overcome Key Challenges January 16, 2023
William Maier, MD, PhD, says the utility of HCs based on RWE should be evaluated for potential applications to increase speed of product approval, reimbursement, and clinical practice adoption.
CLINICAL TRIALS - The Mission to Increase Diverse Clinical Trial Participation January 16, 2023
Lauren Chazal, MBA, and Keidra Gaston, MBA, believe clinical trials are critical to advancing medical knowledge and new therapeutics; however, it is important that participants in clinical trials represent their entire communities and the potential recipients of new treatments.
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial December 27, 2022
DBV Technologies recently announced that the US FDA has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut...Assembly Biosciences Announces Promising Interim Results from Two Clinical Trials Evaluating Highly Potent Next-Generation Core Inhibitor Candidates December 19, 2022
Assembly Biosciences, Inc. recently announced promising interim efficacy, safety and pharmacokinetic (PK) results from two ongoing clinical studies of its...Indaptus Therapeutics Announces Initiation of First-In-Human, Open Label, Dose Escalation & Expansion Multicenter Phase 1 Clinical Trial of Decoy20 in Patients With Advanced Solid Tumors December 13, 2022
Indaptus Therapeutics, Inc. recently announced the initiation of INDP-D101, its first-in-human, open-label, dose escalation and expansion, multicenter Phase 1 clinical...RespireRx Enters Collaboration With National Institute for Neurological Disorders & Stroke to Advance its Lead GABAkine Toward Clinical Development December 5, 2022
RespireRx Pharmaceuticals Inc. recently announced it has been accepted into the NIH HEAL Initiative NINDS Preclinical Screening Platform for Pain...Monopar Announces Encouraging Clinical Data From Ongoing Camsirubicin Phase 1b Trial November 16, 2022
Monopar Therapeutics Inc. recently released encouraging data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft...ExCellThera Announces Completion of Phase 2 clinical Trials for UM171-Expanded Cell Therapy in High-Risk Blood Cancers November 15, 2022
ExCellThera Inc. recently announced the completion of patient enrollment in its initial Phase 2 studies for high-risk leukemias and myelodysplastic...Panoramic Health Launches Clinical Research Division to Drive Discovery of Novel Kidney Disease Therapies October 26, 2022
Panoramic Health recently announced the launch of its clinical research division dedicated to advancing kidney care innovation and improving patient outcomes….
George Clinical Recruits More than 5,000 Patients in the Global Kidney Patient Trials Network October 25, 2022
George Clinical, in close collaboration with The George Institute for Global Health, recently announced the recruitment of more than 5,000...Pistoia Alliance Launches Global Community of Interest to Assess the Environmental Impact of Clinical Trials October 13, 2022
The Pistoia Alliance recently announced the launch of the Clinical Trials Environmental Impact Community of Interest (CoI) to measure and compare the carbon footprint of centralized (traditional site-based) and decentralized clinical trials…..
Forge Biologics Announces Updated Positive Clinical Data in RESKUE, a Novel Phase 1/2 Gene Therapy Trial for Patients With Krabbe Disease October 11, 2022
Forge Biologics recently announced Chief Medical Officer Maria Escolar, MD, MS, presented updated clinical data from the RESKUE Phase 1/2...Silo Pharma Initiates Toxicity Study of its Proprietary Ketamine Formulation for Treatment of Fibromyalgia October 10, 2022
Silo Pharma, Inc. recently announced it has initiated a preclinical toxicity study of its novel time-released, dosage controlled formulation of ketamine, designated as….
CLINICAL TRIALS - Quality Matters in an Evolving Clinical Trial Landscape October 3, 2022
John Buchan reviews best practices for achieving quality by addressing challenges focused on the all-important but growing complexity of managing the distribution of critical safety documents and the processing of Individual Case Study Reports and aggregate reports to sites, Ethic Committees (ECs), IRBs, and others in the reporting chain.
Thermo Fisher Scientific’s PPD Clinical Research Business Selected to Support National Cancer Institute’s Cancer Trials Support Unit September 15, 2022
The PPD clinical research business of Thermo Fisher Scientific Inc. has been awarded a 10-year Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract by...Context Therapeutics & The Menarini Group Announce Clinical Trial Collaboration & Supply Agreement August 2, 2022
Context Therapeutics Inc. and The Menarini Group recently announced a clinical trial collaboration and supply agreement for Menarini’s oral selective...SciSparc Signs Clinical Trial Agreement With Yale University to Conduct Phase 2b Trial in Tourette Syndrome August 1, 2022
SciSparc Ltd. recently announced the addition of another site of excellence, the Yale Child Study Center at Yale University, to...Insilico Medicine Identified Multiple New Targets for ALS Using its AI-Driven Target Discovery Engine July 7, 2022
Insilico Medicine recently announced the company has identified multiple unreported potential therapeutic targets for amyotrophic lateral sclerosis (ALS), using its proprietary AI-driven target discovery engine….
