Pharmaceutical Technology

FEBRUARY 17, 2023

The agency proposes that pharma move away from the common maximum tolerated dose (MTD) to trial designs that prioritise drug dosage optimisation at different stages. In clinical trials, dose-ranging is testing different drug doses against each other to establish which works best.

Clinical Trials 289

Clinical Trials Clinical Trials Trials Drugs 289

Pharmaceutical Technology

DECEMBER 13, 2022

Now, forward-thinking clinical technology providers are seeing an opportunity to apply these back-end approaches to advance software in the healthcare industry. We have a powerful product suite centered around our proven IRT technology,” says McVeigh. Mission accepted.

Clinical Trials 261

Clinical Trials Clinical Trials Trials Production 261

Worldwide Clinical Trials

APRIL 15, 2025

Early Phase Unit, Worldwide Clinical Trials Neurodegenerative diseases represent a diverse group of progressive disorders characterized by the loss of structure and function of neurons. Integration of fluid biomarkers, imaging, and genetic profiling enhances diagnostic precision and provides valuable tools for clinical trials in ALS.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Protein 100

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.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Production 64

Velocity Clinical Research

JANUARY 30, 2025

Velocity Clinical Research, the leading multi-specialty clinical research organization, has partnered with Verified Clinical Trials (VCT) to set a new benchmark for patient safety and data quality in clinical trials through a new technological implementation at Velocitys 80+ global sites.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Pharmaceutical Technology

MAY 20, 2024

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

Contamination 325

Contamination Clinical Trials Clinical Trials Production 325

Rethinking Clinical Trials

JANUARY 6, 2025

Fritz is the principal investigator of BeatPain Utah , an NIH Collaboratory Trial, and is a distinguished professor of physical therapy and athletic training and the associate dean for research in the University of Utah’s College of Health.

Clinical Trials 173

Clinical Trials Clinical Trials Trials Research 173

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.”

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Development 130

Bio Pharma Dive

APRIL 29, 2024

Applying a systems thinking framework to clinical trial design prompts purposeful and productive collaboration among stakeholders.

Clinical Trials 144

Clinical Trials Clinical Trials Trials Production 144

Camargo

NOVEMBER 22, 2021

In this Q&A, Andrea discusses their experience, especially as it relates to the two clinical trials Tom participated in. We wanted to participate in a clinical trial. But our original doctor doesn’t work with clinical trials—it’s just not his thing. You aren’t thinking about treatments and trials.

Clinical Trials 198

Clinical Trials Clinical Trials Trials Research 198

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.

Production 69

Production Clinical Development Development Regulation 69

Worldwide Clinical Trials

APRIL 8, 2025

Challenges in PD Clinical Trial Design One of the primary challenges in clinical trial design for PD is the imprecise understanding of the diseases pathogenesis. Using these indicators to diagnose early is key in PD treatment.

Research 124

Research Clinical Trials Clinical Trials Trials 124

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

Trials 189

Trials Clinical Trials Clinical Trials Drugs 189

XTalks

OCTOBER 23, 2024

Oxford Medical Products has shared promising safety data from a first-in-human study for its ‘mechanical’ weight loss pill. In Oxford Medical’s first-in-human trials, conducted in a diverse patient group, data shows that the pill is well-tolerated, with no significant adverse events reported.

Production 104

Production Hormones Drugs Trials 104

Worldwide Clinical Trials

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Any delays or missteps in bioanalysis during a Phase I trial can derail the trajectory of a promising drug.

Clinical Trials 195

Clinical Trials Clinical Trials Drugs Trials 195

Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

Clinical Trials 147

Clinical Trials Clinical Trials Regulation Trials 147

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 29, 2024

Click here Diagnostics + Font Resize – NABL launches comprehensive training programme to enhance competence in reference material production Shardul Nautiyal, […]

Production 246

Production Clinical Trials Clinical Trials Clinical Research 246

Pharmaceutical Technology

FEBRUARY 19, 2025

Clinical trial complexity has significantly increased in the past decade. How can the industry adapt and innovate to remain productive?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

CTTI (Clinical Trials Transformation Initiative)

OCTOBER 17, 2024

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 clinical trials.

Clinical Trials 81

Clinical Trials Clinical Trials Trials Production 81

Imperical Blog

JANUARY 9, 2025

Clinical trial ancillary equipment and supplies encompass an astonishing variety of products and categories. This includes everything one might need to conduct a clinical trial, from IV bags to centrifuges, blood pressure monitors to syringes, refrigerators, and everything in between.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 21, 2024

Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.

Manufacturing 189

Manufacturing Development Compliance Drugs 189

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial 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.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

Pharmaceutical Technology

OCTOBER 3, 2024

Eli Lilly has announced a $4.5bn investment to establish the Lilly Medicine Foundry for drug production and manufacturing medicines for clinical trials.

Manufacturing 130

Manufacturing Medicine Production Trials 130

Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

Trials 69

Trials Clinical Trials Clinical Trials Production 69

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 3, 2024

Evidence does not support the use of cannabidiol (CBD) products as a treatment for chronic pain, a new review found.

Production 246

Production Packaging Packaging Clinical Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller.

Production 188

Production Clinical Trials Clinical Trials Compliance 188

Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials 200

Trials Clinical Trials Clinical Trials Regulation 200

Pharmaceutical Technology

MARCH 6, 2023

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. It will also be potentially used for wider commercial use or supply as a cGMP pharmaceutical-grade product.

Manufacturing 264

Manufacturing Clinical Trials Clinical Trials Production 264

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 9, 2024

Exports of Ayush (Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy) drugs and herbal products from the country have reported 1.65 per cent growth during the first ten months of the current fiscal year. The growth in the month of January stood at 14.54

Production 246

Production Drugs Clinical Trials Clinical Trials 246

Bio Pharma Dive

SEPTEMBER 13, 2021

The CGT industry is expected to grow 30% between 2019 and 2025, and the transition from clinical trials to commercial-scale production is now seen as inevitable.

Gene Therapy 246

Gene Therapy Clinical Trials Clinical Trials Gene 246

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 7, 2024

The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) (..)

Production 245

Production Drugs Clinical Trials Clinical Trials 245

Drug Patent Watch

DECEMBER 9, 2024

This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.

Clinical Trials 97

Clinical Trials Clinical Trials Immune Response Production 97

XTalks

DECEMBER 10, 2024

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.

Trials 104

Trials Protein Clinical Development Drugs 104

Pharmaceutical Technology

MARCH 28, 2023

In December 2022, BioNTech initiated a Phase I clinical trial of BNT163 – an HSV vaccine candidate. In the same month, BioNTech also initiated a Phase I clinical trial (NCT05581641) of the multi-antigen malaria vaccine BNT165b1— the first candidate from the company’s BNT165 program.

Vaccine 276

Vaccine Vaccination Development Clinical Trials 276

Worldwide Clinical Trials

MAY 1, 2024

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 clinical trials.

Clinical Research 173

Clinical Research Trials Research Clinical Trials 173

Pharmaceutical Technology

JANUARY 6, 2023

Currently, there is a range of cell therapies and gene-modified cell therapies in development, from the discovery stage to Phase II clinical trials, with six different cell therapies in Phase II development. For example, this trend can be seen for ATA-188.

Clinical Trials 289

Clinical Trials Clinical Trials Trials Development 289

XTalks

APRIL 15, 2025

The landscape of rare disease clinical trials has seen significant transformation over the past decade. However, many challenges remain in ensuring patient access, optimizing trial design and leveraging technological advancements to improve outcomes.

Trials 52

Trials Clinical Trials Clinical Trials Gene Therapy 52