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Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s
AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinicaltrials. By leveraging AI technologies, we could create a more accessible and equitable approach to clinicaltrials, breaking down barriers to participation and ensuring diverse representation among participants.
“James’ proven leadership skills, and deep knowledge of all phases of clinicalresearch, will be invaluable in delivering expert guidance for our clients along their early-phase clinical journey,” said Ingrid Holmes, Vice President, Clinical Operations, Altasciences.
One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinicaltrial and assigning patients to placebo may be unethical.
Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinicalpharmacology units. Clinical Supply Manufacturing Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.
Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to extend through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis. CESTidentified through 52 weeks of knowledge.
This is another study that is strongly supportive of replication and further development, including clinicaltrial development. In both newly diagnosed and recurrent PDX models the drug was shown to be non-toxic and to have meaningful anti-GBM activity - including a survival benefit.
12/29/2023 FDORA, Section 3602 ClinicalTrials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinicaltrials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.
District Court March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinicaltrials of products intended to treat the disease expires. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing.
How Improving Diversity Can Benefit ClinicalTrials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinicaltrials, which is expected to become a final guidance by June 2025.
EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinicaltrials of products intended to treat the disease expires.
These advances are reshaping how pharmaceutical and biotechnology companies approach clinicaltrial design, with a focus on patient-centric dosing strategies. This article explores how innovations in precision medicine are reshaping clinicaltrials, followed by a discussion on Project Optimus and its impact on dose optimisation.
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