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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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. And that has a lot of downstream consequences.”

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Outsourcing Pharma

JANUARY 9, 2024

Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

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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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XTalks

OCTOBER 4, 2024

The push to increase diversity in clinical trials has gained momentum, but true progress requires more than regulatory mandates. In this webinar, industry leaders and patient advocates discussed how authenticity and the patient voice can be leveraged to enhance diversity in clinical trials.

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XTalks

NOVEMBER 19, 2024

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 clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2024

Under […]

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CTTI (Clinical Trials Transformation Initiative)

OCTOBER 15, 2024

The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making The post The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making appeared first on CTTI.

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Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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Outsourcing Pharma

OCTOBER 10, 2024

The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.

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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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ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. MGI puts the value of this contribution to clinical development at $15 billion to $25 b illion.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

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Clinical Trials Clinical Trials Regulation Trials 96

XTalks

SEPTEMBER 25, 2024

Patient-centricity isn’t a catchphrase in clinical trials—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, Clinical Trial Financial Management Medidata Alicia C.

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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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Pharmaceutical Technology

OCTOBER 14, 2022

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs.

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Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

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STAT News

OCTOBER 13, 2022

Relmada Therapeutics said Thursday that its experimental treatment for depression failed to achieve the primary goals of a large clinical trial, a significant setback for the company’s only medicine in clinical development.

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Pharmaceutical Technology

NOVEMBER 28, 2022

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. This includes an upfront payment of $2m from AstraZeneca.

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Pharmaceutical Technology

MAY 26, 2023

HanAll Biopharma and Daewoong Pharmaceutical have entered into a co-development deal with NurrOn Pharmaceuticals to develop therapy for Parkinson’s disease (PD) and other neurodegenerative disorders. Nurr1 is a class of proteins important for the development and maintenance of dopamine in the brain.

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Outsourcing Pharma

JULY 2, 2024

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Development 95

XTalks

JULY 29, 2024

Orphan drug development poses many challenges that are unique to rare diseases, including recruitment in small patient populations, variable progression with heterogenous clinical manifestations and limited understanding of disease progression and natural history. Read on to learn key lessons in rare disease drug development.

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XTalks

SEPTEMBER 12, 2024

Ryan Brown Regional Vice President Sales-Trial Landscape H1 Diversity in clinical trials is not just a regulatory box to check — it’s an ethical imperative and a scientific necessity. For instance, one common barrier is language.

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Pharmaceutical Technology

NOVEMBER 30, 2022

However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development. Nonetheless, the increased focus on the development of PPMS treatment is a welcome game-changer for patients.

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Clinical Trial Podcast

SEPTEMBER 26, 2022

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. Cohen to the Clinical Trial Podcast.

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XTalks

AUGUST 19, 2024

The synergy between clinical trial quality and operations teams is vital for delivering value to sponsors. Clinical trial sponsors often face the challenge of managing complex projects with multiple stakeholders, each with their own priorities and workflows.

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Outsourcing Pharma

MARCH 13, 2024

In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes.

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Outsourcing Pharma

JUNE 19, 2024

During a panel discussion held at DIA Global in San Diego this week, which was moderated by Peter Wahl, industry experts delved into the integration of real-world (RW) data and advanced technologies to accelerate drug development.

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Outsourcing Pharma

JULY 2, 2024

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

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XTalks

AUGUST 16, 2024

The effectiveness of clinical trials often depends on the quality and depth of the data utilized. This rich data resource has significant potential to innovate clinical trials, providing real-world, timely insights that can enhance success and streamline trial processes.

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BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

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Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

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Clinical Trials Clinical Trials Regulation Trials 52

pharmaphorum

AUGUST 24, 2022

Diversity in clinical trials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”? Removing barriers to clinical trial participation for underserved groups is an essential part of addressing health inequalities. Clinical trial participation, she went on, was vital.

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Outsourcing Pharma

JULY 12, 2023

Ora, a clinical research organization (CRO) for ophthalmology pharmaceutical and device development, has partnered the North West London Clinical Trials Alliance, to improve the quality and access to clinical research in the region.

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Clinical Trials Clinical Trials Trials Clinical Research 91

Outsourcing Pharma

JULY 12, 2023

The Israeli company Galmed Pharmaceuticals is deploying artificial intelligence (AI) tools developed by the U.S. company OnKai to help carry out clinical trials of a rare disease treatment in communities that have low access to healthcare.

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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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