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Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
These issues carry substantial personal and societal costs, impacting daily life and productivity. Despite advancements in neuroscience and psychiatry, clinicaltrials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges.
In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinicaltrial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinicaltrial designs.
Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s ClinicalTrials Nexus, I had the privilege of representing Worldwide ClinicalTrials as the sole CRO on a panel discussion: “Reversing the Conversation: What the ClinicalTrial Industry Really Wants from its Service Providers.”
A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinicaltrials.
Regulatory bodies such as the FDA oversee clinicaltrials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. At Worldwide ClinicalTrials, WorldwideEdgeTM is our initiative to embrace efficiency, innovation, and teamwork.
Stephanie Manson Brown, VP & Head of ClinicalDevelopment & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine.
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinicaltrial in China to evaluate SM17’s safety profile.
Pharmaceutical companies often struggle to actively involve patients in the design phase of clinicaltrials but doing so can have huge benefits for the sustainability and success of research. How the NIHR’s Patient Engagement in ClinicalDevelopment service can help.
The therapy showed that it can inhibit the production of cytokine from both CD4+ T cells and ILC2, and completely suppressed skin allergic reactions in a monkey model in pre-clinicaltrials. It targets the human thymic stromal lymphopoietin receptor to inhibit signalling.
Plus Therapeutics has expanded its partnership with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug products. This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinicaltrials that are underway and planned.
This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinicaltrials.
Diversity in clinicaltrials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”? Removing barriers to clinicaltrial participation for underserved groups is an essential part of addressing health inequalities. Clinicaltrial participation, she went on, was vital.
To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinicaltrials. Cohen has more than 30 years of healthcare experience which includes his work on clinicaldevelopment. Cohen to the ClinicalTrial Podcast.
On February 7, at a town hall organised to discuss clinicaltrial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.
In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide ClinicalTrials Early Phase Services, Keith Fern. Keith Fern joins Elligo with a decade of proven leadership in the CRO industry.
Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.
According to the deal, C4XD is entitled to get up to $16m in pre-clinical milestone payments before the commencement of the first clinicaltrial. . on meeting clinicaldevelopment and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product.
Rilzabrutinib joins a wave of innovative ITP therapies , including thrombopoietin-receptor agonists like eltrombopag and romiplostim, which boost platelet production. By inhibiting this protein, the drug disrupts pathways that contribute to platelet destruction and insufficient production.
Leading clinicaltrials technology platform provider Medable announced a new partnership with Nova Scotia Health Innovation Hub for a two-year pilot study to improve oncology trial access for patients in rural Nova Scotia through Medable’s decentralized clinicaltrial (DCT) platform.
The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinicaldevelopment is not only a moral imperative but a strategic necessity in modern medical research.
In clinical research, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products. Access to information: Limited resources and educational materials hinder informed decision-making about trial participation.
Of the 19 products currently in clinicaldevelopment for PPMS (Figure 1), there are three novel agents deemed to be in late-stage development (late-stage Phase IIb and Phase III): AB Sciences’ masitinib, Sanofi’s tolebrutinib, and Roche’s fenebrutinib.
In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinicaltrials. Data security: The clinicaltrial data is backed-up and secure.
During clinicaldevelopment, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide ClinicalTrials.
As a provider of end-to-end clinicaldevelopment solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis. At Worldwide, we deliver full-service clinicaldevelopment to support drug approval and commercialization.
Influenza vaccine 2 is under clinicaldevelopment by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. Attributes of the drug, company and its clinicaltrials play a fundamental role in drug-specific PTSR and likelihood of approval.
Influenza vaccine 2 is under clinicaldevelopment by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. Attributes of the drug, company and its clinicaltrials play a fundamental role in drug-specific PTSR and likelihood of approval.
Myeloid Therapeutics has raised $73m to support the continued clinicaldevelopment of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. The financing will help to fast-track the development of other in vivo programming candidates into clinicaltrials.
Highlights include expansion of biotech operations in Philadelphia, acquisition of a new pharma-device facility near Dublin, Ireland, and a new Center of Excellence for advanced drug delivery and drug-device combination product assembly in Rockford, Illinois.
The latest approval is based on findings from the Phase III clinicaltrials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?
As the strategists for Worldwide ClinicalTrials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. With rare disease studies, we delve into orphan indications using specialized products tailored for these individual cases, often encountering a limited pool of patients.
Patient-centricity isn’t a catchphrase in clinicaltrials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. Meghan Harrington VP, ClinicalTrial Financial Management Medidata Alicia C.
This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”
KFA-115 is under clinicaldevelopment by Novartis and currently in Phase I for Melanoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
The proceeds from the business combination will be utilised to advance the pipeline of Disc to clinicaltrials and offer funding into 2025. Disc focuses on discovering and developing new therapies for patients with serious haematologic ailments. Last year, Disc in-licensed bitopertin from Roche.
P-BCMA-ALLO1 is currently being analysed in a Phase I clinicaltrial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. Roche and Poseida will also partner in a research programme for creating and developing next-generation features and enhancements for allogeneic CAR-T therapies.
PathAI has expanded a multi-year partnership agreement with Bristol Myers Squibb (BMS) to leverage artificial intelligence (AI)-powered pathology in translational research and clinicaltrials. The post PathAI expands AI-driven partnership with BMS appeared first on Pharmaceutical Technology.
Zerion Pharma has entered a partnership with Insud Pharma for the development and marketing of drug products using Zerion Pharma's solubility-boosting Dispersome technology. . Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs.
Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies. Presumably, the difference reflects an anticipated higher volume of regulatory submissions from developers of cell and gene therapies, compared to conventional drug products.
When conducting first-in-human (FIH) clinicaltrials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?
These strategic deals have reshaped the competitive landscape, spurred innovation and enabled companies to diversify their product offerings, expand into new markets and enhance operational efficiencies. This merger aimed to create a broader and more diversified product portfolio in medical devices and therapies. billion in 2021.
(LAI-287 + semaglutide) is under clinicaldevelopment by Novo Nordisk and currently in Phase III for Type 2 Diabetes. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
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