Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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Trials Clinical Trials Clinical Trials Development 242

Worldwide Clinical Trials

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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Genetics Trials Clinical Trials Clinical Trials 189

Worldwide Clinical Trials

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

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Trials Clinical Trials Clinical Trials Clinical Development 189

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”

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Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research. Integrating DHTs Across Drug Development Phases Dr.

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Clinical Development Development Clinical Trials Clinical Trials 116

Pharmaceutical Technology

JUNE 9, 2023

Upstream Bio will use the funds to advance its UPB-101 into Phase II trials to treat asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). It is also preparing for a swift transition to Phase III development. It targets the human thymic stromal lymphopoietin receptor to inhibit signalling.

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Clinical Development Development Life Science Clinical Trials 147

XTalks

NOVEMBER 1, 2023

Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. She also spoke about clinical trials in the space, including Allergan Aesthetics’ commitment to increasing diversity in trials and developing products that do not cater to any one beauty standard.

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Life Science Clinical Trials Clinical Trials Clinical Development 105

Medical Xpress

APRIL 26, 2023

A successful gene therapy trialed at Michigan State University in dogs with an inherited eye disease is ready to be developed for clinical use in human patients with a rare condition called retinitis pigmentosa.

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Clinical Development Gene Therapy Development Gene 133

Pharmaceutical Technology

JULY 1, 2022

The latest filing is based on non-clinical and clinical data for Paxlovid and also comprised data from the Phase II/III EPIC-HR clinical trial. Furthermore, findings from the final trial report showed a relative risk decline of 86%.

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HR Clinical Development Trials Vaccine 264

Worldwide Clinical Trials

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

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Clinical Trials Clinical Trials Trials Clinical Development 130

Pharmaceutical Technology

DECEMBER 1, 2022

Rebyota’s safety and efficacy were analysed in the largest trial programme in the microbiome-based therapeutics field, including five trials enrolling over 1,000 subjects. The latest development is based on the findings from the clinical programme including the double-blind, randomised, placebo-controlled Phase III PUNCH CD3 trial.

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FDA Approval Trials Clinical Development Development 264

Pharmaceutical Technology

JUNE 6, 2023

Gildeuretinol is the first and only medicine in clinical development to treat Stargardt disease by reducing vitamin A dimerization in the eye, without affecting normal vision. It decreased vitamin A dimerization by more than 80% and prevented blindness in a genetic animal model of the disease in preclinical trials.

Genetics 279

Genetics Life Science Trials Clinical Development 279

Pharmaceutical Technology

MARCH 23, 2023

BHV-8000’s mechanistic proof of concept was showed in several pre-clinical models. This year, Biohaven is expecting to advance the TYK2/JAK1 inhibitor into a Phase I trial. Hangzhou Highlightll will also receive up to $950m in development and commercial milestone payments and tiered royalties.

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Licensing Licensing Clinical Development Development 263

Pharma Mirror

JUNE 8, 2022

The post Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China appeared first on Pharma Mirror Magazine. According to the Endpoints ASCO session: “China and the US are the world’s largest oncology research destinations, and the.

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Clinical Trials Clinical Trials Trials Clinical Development 130

XTalks

DECEMBER 10, 2024

In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Participants received either rilzabrutinib or placebo for 24 weeks, followed by an open-label extension.

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Trials Protein Clinical Development Drugs 104

Worldwide Clinical Trials

JUNE 13, 2024

The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

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Trials Clinical Trials Clinical Trials Clinical Development 130

Pharmaceutical Technology

MARCH 10, 2023

It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulations. The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials.

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FDA Approval Pharmacy Trials Clinical Development 246

Pharmaceutical Technology

OCTOBER 14, 2022

It is currently being assessed in combination with Merck’s anti-PD-1 therapy, Keytruda, as an adjuvant treatment for high-risk melanoma patients in a Phase II clinical trial being conducted by Moderna. The company said that the data from the ongoing Phase II trial will be reported in the fourth quarter of this year.

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Vaccine Vaccination Development Immune Response 289

BioPharma Reporter

DECEMBER 13, 2021

Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.

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Antibody Clinical Trials Clinical Trials Clinical Development 140

XTalks

DECEMBER 10, 2024

The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

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Immune Response Clinical Trials Clinical Trials Antibody 273

Pharmaceutical Technology

APRIL 3, 2023

The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China. It is based on RayzeBio’s specialisation in targeted radiotherapy (TRT) discovery and Ablaze’s know-how in therapeutic product clinical development, as well as on the radiopharmaceutical infrastructure in China.

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Development Drugs Clinical Development Licensing 246

Outsourcing Pharma

DECEMBER 15, 2021

The artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.

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Trials Medicine Drugs Clinical Development 141

XTalks

JANUARY 17, 2024

Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

Pharmaceutical Technology

AUGUST 25, 2022

The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial.

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Gene Therapy Gene Clinical Trials Clinical Trials 264

Worldwide Clinical Trials

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. This philosophy is encapsulated in our belief: “If you’ve seen one trial for a rare indication, you’ve seen one trial.”

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Trials Clinical Trials Clinical Trials Research 204

Pharmaceutical Technology

MAY 17, 2023

TAK-755 is the first and only treatment in clinical development that provides targeted replacement of ADAMTS13, addressing the underlying cause of the disease. “We The Phase III trial assessed TAK-755’s clinical benefit across several clinically relevant endpoints, against plasma-based therapies, in a randomised cross-over study.

Genetics 242

Genetics Clinical Development Trials Drugs 242

Worldwide Clinical Trials

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” Umbrella Trial: Examines numerous drugs administered as individual drugs or combinations in a single tumor type.

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Trials Clinical Trials Clinical Trials Drugs 208

Pharmaceutical Technology

FEBRUARY 22, 2023

Biohaven Clinical Development vice-president Lindsey Lee Lair said: “We are very pleased the FDA granted Fast Track designation for taldefgrobep alfa for the treatment of SMA. Currently, the company is enrolling participants in a Phase III clinical trial of taldefgrobep to treat SMA.

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Clinical Trials Clinical Trials Genetics Protein 246

Pharmaceutical Technology

NOVEMBER 30, 2022

The latest development is based on data obtained from an open-label clinical trial of Biktarvy. According to the trial findings, the treatment was demonstrated to be effective and well-tolerated through 24 weeks in adolescents who are virologically suppressed and children with HIV infection.

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Marketing FDA Approval Clinical Trials Clinical Trials 246

Pharmaceutical Technology

NOVEMBER 30, 2022

Of the 19 products currently in clinical development 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.

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Development Clinical Trials Clinical Trials Trials 246

Pharmaceutical Technology

MAY 19, 2023

Myeloid Therapeutics has raised $73m to support the continued clinical development 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 clinical trials.

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Outsourcing Pharma

JANUARY 9, 2024

has announced a new intelligent automation technology applied across its clinical trials platform it hopes will cut standard trial build timelines by at least half. Medable Inc.

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Clinical Trials Clinical Trials Trials Clinical Development 102

XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

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Clinical Trials Clinical Trials Trials Clinical Research 97

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 3, 2023

The Institute is now looking for partners in pharma companies to pursue further clinical development of the findings. Researchers at the Indian Institute of Science (IISc) have found that picolinic acid, a natural compound produced by mammalian cells, can block several disease-causing viruses such as SARS-CoV-2 and influenza A viruses.

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Pharma Companies Research Clinical Development Development 188

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. The Phase III VISIONARY trial enrolled 530 adults aged 18 to 65, with varying degrees of kidney function, and most were at risk of progressing to end-stage kidney disease.

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Trials Clinical Trials Clinical Trials Antibody 101

FDA Law Blog

NOVEMBER 10, 2024

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 clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Production Clinical Development Development Regulation 69