Production and Trials - Clinical Research Informer

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

Gene Therapy

Gene Therapy Clinical Supply Trials Gene

[Podcast] The Power of Persistence: From Biotech Incubator to Product Launch

Bio Pharma Dive

JUNE 5, 2024

How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.

Production

Production Clinical Trials Clinical Trials Trials

Strategies for effective biosimilar clinical trial design and execution

Drug Patent Watch

JANUARY 23, 2025

One key aspect of this journey is the clinical trial design and execution process a critical step that can make or break the success of a biosimilar product. When it comes to designing clinical trials for biosimilars, there are several key considerations to keep in mind. What are your thoughts on the future of biosimilars?

Clinical Trials

Clinical Trials Clinical Trials Trials Production

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

MORE WEBINARS

New ‘Mechanical’ Weight Loss Pill from Oxford Medical Products Shows Positive Safety Data

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

Production Hormones Drugs Trials

Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors successfully navigate these challenges.

Clinical Trials

New Publication Shares Insights on Decentralized Clinical Trial Elements in Cancer Trials During the COVID-19 Pandemic

CTTI (Clinical Trials Transformation Initiative)

MARCH 19, 2025

A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinical trial (DCT) elements were used in cancer trials leading to FDA approval during the COVID-19 pandemic.

Clinical Trials

Clinical Trials Clinical Trials Trials FDA Approval

NABL launches comprehensive training programme to enhance competence in reference material production

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

Production Clinical Trials Clinical Trials Clinical Research

Psychiatry Clinical Trials: Inclusive, Patient-Centric Approaches for Mental Health Research

XTalks

DECEMBER 19, 2024

These issues carry substantial personal and societal costs, impacting daily life and productivity. Despite advancements in neuroscience and psychiatry, clinical trials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Export of Ayush and herbal products registers 1.65% growth in first 10 months

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

Production Drugs Clinical Trials Clinical Trials

Large Review Finds CBD Products Don’t Relieve Chronic Pain After All

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

Production Packaging Packaging Clinical Trials

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

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

Production Clinical Development Development Regulation

Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials

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

Trials Protein Clinical Development Drugs

Regulatory considerations for biosimilar clinical efficacy trials

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

Trials Clinical Trials Clinical Trials Production

Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production

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

Manufacturing Medicine Production Trials

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

Clinical Trials

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain

CDSCO issues draft revised guidance on quality & safety documents for post approval changes in biological products

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

Production Drugs Clinical Trials Clinical Trials

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

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

Manufacturing Development Compliance Drugs

FDA suggests ways to curb constraints with rare disease gene therapy trials

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

Gene Therapy Gene Trials Clinical Trials

Ayush and herbal products exports grow over 20% in April

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 27, 2024

Exports of Ayush and herbal products have reported a growth of 20.33 per cent during the first month of the current fiscal year, at $51.44 million as compared to $42.75 million during the same month of previous fiscal year. Exports during the month of April, in Rupee terms, have reported a 21 per cent growth, […]

Production

Production Clinical Trials Clinical Trials Clinical Research

Final report says UK infected blood scandal “should have been avoided”

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

Contamination Clinical Trials Clinical Trials Production

Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

Worldwide Clinical Trials

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. But how do they work, and when are they appropriate? What Are Master Protocols?

Trials

Trials Production Development Clinical Trials

CDSCO releases updated version of guidance for PAC in biological products

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 2, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released an updated version of the guidance for Post Approval Changes in Biological Products, regarding the quality, safety and efficacy documents in order to align with the updated standards and digital formats developed after the previous version was rolled out. of […]

Production

Production Development Drugs Clinical Trials

Eli Lilly's Zepbound defeats Novo Nordisk's Wegovy in head-to-head weight loss trial

Fierce Pharma

DECEMBER 3, 2024

Over the last two-plus years, as Eli Lilly and Novo Nordisk have battled for their share of the massive weight loss market and patients wondered which company’s products were more effective, there | Eli Lilly revealed results from a study that showed its obesity drug Zepbound was 47% more effective than Novo’s Wegovy in helping patients lose weight. (..)

Trials

Trials Production Marketing Drugs

Ayush and herbal products exports register 3.6% growth in 2023-24

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 9, 2024

India’s export of Ayush and herbal products has reported a growth of 3.6 per cent during the fiscal year 2023-24, at $651.17 million as compared to the same period of previous year, registering a below-five per cent growth for the second consecutive year. The country reported exports of 10.63

Production

Production Clinical Trials Clinical Trials Trials

January 6, 2025: Fritz and Rhon to Present Strategies for Pain Management in the Military Health System

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

Clinical Trials Clinical Trials Trials Research

Diversity Action Plans (DAPs) in Clinical Trials Are No Longer a “Nice-to-Have” — Are You Ready?

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. Baker McDowell, Head of Regulatory Strategy.

Clinical Trials

Clinical Trials Clinical Trials Trials Production

SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver

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

Trials Clinical Trials Clinical Trials Drugs

Bluebird says gene therapy 'very unlikely' cause of cancer case in trial

Bio Pharma Dive

MARCH 10, 2021

and European regulators in hopes of resuming study of the treatment as well as sales of a related product. The biotech is discussing its findings with U.S.

Gene Therapy

Gene Therapy Gene Sales Regulation

Exports of Ayush related products grew 53% in five years till FY 21

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 24, 2023

Exports of Ayush related products from the country have gone up around 53 per cent in five years from the financial year 2016-17 to 2020-21, according to the Ministry of Ayush. The imports, on the other hand, has increased around 42 per cent during the period, with a majority of the products based on the […]

Production

Production Clinical Trials Clinical Trials Clinical Research

Optimizing Research Productivity Using Data-Driven Protocol Feasibility

ACRP blog

FEBRUARY 5, 2025

As many as 20% to 50% of clinical trials do not accrue participants at the site level, leading to wasted time and financial resources. This waste can be minimized by early selection of trials most likely to succeed. Clinical research is a business that should focus on viable studies.

Production

Production Research Clinical Trials Clinical Trials

DCGI issues alert on suspected falsified GLP-1-RA products in the market

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 23, 2023

The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. GLP-1-RA […]

Production

Production Marketing Regulation Drugs

IPC introduces draft amendment to microbial contamination in non-sterile products in IP 2022

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 3, 2022

In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022.

Contamination

Contamination Production Clinical Trials Clinical Trials

Top 10 countries accounted for India’s 63% of Ayush and herbal products export in 2023-24

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 16, 2024

per cent of India’s Ayush and herbal products during the fiscal year 2023-24. The top 10 destinations led by USA, Germany and Italy accounted for almost 63.3 Exports to these 10 countries together stood at $412 million, with a growth of 5.10 per cent compared to the $392 million exports to top 10 destinations during […]

Production

Production Clinical Trials Clinical Trials Clinical Research

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

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

Trials Clinical Trials Clinical Trials Regulation

Agilent Technologies wins two scientists’ choice awards for drug discovery and development products

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 15, 2024

a global leader in analytical and clinical laboratory technologies, announced that it has received two prestigious awards from SelectScience: Best New Drug Discovery & Development Product of 2023 and Drug Discovery & Development Webinar of the Year. Agilent Technologies Inc.,

Production

Production Development Scientist Drugs

Indian medical devices cos to invest in innovation for products minimizing environmental footprint

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 3, 2023

Indian medical devices companies are increasingly looking to invest in innovation for developing products that help to minimize environmental footprint.

Production

Production Genome Genomics Development

Biopharmaceutical drugs’ affordability driven by R&D cost and production complexity: Dr Tumbagi

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

Production Clinical Trials Clinical Trials Compliance

Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations

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

Clinical Trials Clinical Trials Drugs Trials

Navigating Varying Regulatory Feedback in Clinical Oncology Trials: A Guide for Clinical Research Professionals

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

Clinical Research Trials Research Clinical Trials

Recent CTTI Publication Reviews Current Applications and Future Opportunities for Disease Progression Modeling

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

Clinical Trials Clinical Trials Trials Production

PAN-TB’s Phase II trials take a shot at shorter TB regimens

Pharmaceutical Technology

AUGUST 26, 2022

Last week, the collaborative announced that it is executing a joint development agreement (JDA) to advance two novel drug regimens to Phase II clinical trials by 2023. Each trial will recruit approximately 500 patients. According to GlobalData, there are only two TB drugs that are currently in Phase III clinical trials.

Trials

Trials Clinical Trials Clinical Trials Drugs

Cabinet approves signing of MoUs between India and Suriname in the field of medical products regulation

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 24, 2023

An MoU […]

Regulation

Regulation Production Drugs Clinical Trials

Grand Rounds January 24, 2025: The HEALing Communities Study – 10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths (Jeffrey H. Samet, MD, MA, MPH)

Rethinking Clinical Trials

JANUARY 30, 2025

The research team conducted the cluster randomized trial in 67 communities across Ohio, Kentucky, New York, and Massachusetts a total study population of about 10 million. This was partially a product of the stakes; the death toll of the opioid epidemic was high and the team was motivated to make quick progress.

Trials

Trials Contamination Medicine Clinical Trials

Roche trial confirms Vabysmo efficacy in minorities

pharmaphorum

OCTOBER 21, 2024

billion in the first half of the year.

Trials

Trials Sales Production

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

[Podcast] The Power of Persistence: From Biotech Incubator to Product Launch

Webinars

Trending Sources

Strategies for effective biosimilar clinical trial design and execution

Webinars

New ‘Mechanical’ Weight Loss Pill from Oxford Medical Products Shows Positive Safety Data

Commercial Drug Sourcing for Clinical Trials

New Publication Shares Insights on Decentralized Clinical Trial Elements in Cancer Trials During the COVID-19 Pandemic

NABL launches comprehensive training programme to enhance competence in reference material production

Psychiatry Clinical Trials: Inclusive, Patient-Centric Approaches for Mental Health Research

Export of Ayush and herbal products registers 1.65% growth in first 10 months

Large Review Finds CBD Products Don’t Relieve Chronic Pain After All

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials

Regulatory considerations for biosimilar clinical efficacy trials

Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

CDSCO issues draft revised guidance on quality & safety documents for post approval changes in biological products

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

FDA suggests ways to curb constraints with rare disease gene therapy trials

Ayush and herbal products exports grow over 20% in April

Final report says UK infected blood scandal “should have been avoided”

Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

CDSCO releases updated version of guidance for PAC in biological products

Eli Lilly's Zepbound defeats Novo Nordisk's Wegovy in head-to-head weight loss trial

Ayush and herbal products exports register 3.6% growth in 2023-24

January 6, 2025: Fritz and Rhon to Present Strategies for Pain Management in the Military Health System

Diversity Action Plans (DAPs) in Clinical Trials Are No Longer a “Nice-to-Have” — Are You Ready?

SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver

Bluebird says gene therapy 'very unlikely' cause of cancer case in trial

Exports of Ayush related products grew 53% in five years till FY 21

Optimizing Research Productivity Using Data-Driven Protocol Feasibility

DCGI issues alert on suspected falsified GLP-1-RA products in the market

IPC introduces draft amendment to microbial contamination in non-sterile products in IP 2022

Top 10 countries accounted for India’s 63% of Ayush and herbal products export in 2023-24

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Agilent Technologies wins two scientists’ choice awards for drug discovery and development products

Indian medical devices cos to invest in innovation for products minimizing environmental footprint

Biopharmaceutical drugs’ affordability driven by R&D cost and production complexity: Dr Tumbagi

Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations

Navigating Varying Regulatory Feedback in Clinical Oncology Trials: A Guide for Clinical Research Professionals

Recent CTTI Publication Reviews Current Applications and Future Opportunities for Disease Progression Modeling

PAN-TB’s Phase II trials take a shot at shorter TB regimens

Cabinet approves signing of MoUs between India and Suriname in the field of medical products regulation

Grand Rounds January 24, 2025: The HEALing Communities Study – 10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths (Jeffrey H. Samet, MD, MA, MPH)

Roche trial confirms Vabysmo efficacy in minorities

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