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.

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XTalks

DECEMBER 18, 2024

CAH is a group of rare genetic disorders affecting the adrenal glands, which produce essential hormones like cortisol, aldosterone and androgens. In the first trial, 122 adults received Crenessity twice daily and 60 received placebo twice daily for 24 weeks.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 18, 2024

Indian healthcare industry is of the view that emergence of genetic diagnostics will be a paradigm shift towards personalized medicine. Through the ever-evolving landscape of healthcare, the role of genetic diagnostics offers personalized insights and proactive solutions for disease management and prevention.

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Genetics Medicine Development Drugs 189

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 17, 2024

We are witnessing a revolution in healthcare, driven by advances in genetics, Omics, RNA and CRISPR gene-editing technology, to deliver precision and personalised medicine, said Kiran Mazumdar-Shaw, executive chairperson, Biocon and Biocon Biologics. This holds the potential to cure genetic diseases that have plagued families for generations.

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Genetic Disease Genetics Gene Editing Medicine 189

Worldwide Clinical Trials

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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Worldwide Clinical Trials

JANUARY 6, 2025

Biomarkers are indispensable tools in clinical trials, providing critical insights that enhance the efficiency and precision of drug development. Our biomarker testing capabilities, offered across BioA and Clinical Pharmacology Unit (CPU) sites, provide a comprehensive and tailored approach to biomarker analysis.

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Clinical Trials Clinical Trials Trials Genetics 130

Worldwide Clinical Trials

NOVEMBER 12, 2024

CGTs address rare and complex diseases at the root cause with increasing use in cancer, genetic disorders, and autoimmune diseases. Thus, selecting a CRO with global experience managing cell therapy clinical logistics is critical. Contact us today to discuss your cell therapy trials with our cell and gene therapy experts.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 14, 2023

Indian healthcare looks at pharmacogenomics, the study of influence of genetic factors on drug response, in patient care as comprehensive genetic tests gain ground.

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Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Worldwide Clinical Trials

FEBRUARY 6, 2023

When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed. Read the full article!

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Genetics Clinical Trials Clinical Trials Genotype 130

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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STAT News

DECEMBER 10, 2022

NEW ORLEANS — An emerging class of genetically targeted drugs is inducing remissions in about one-third of patients with advanced leukemia, according to updates Saturday from separate clinical trials. Continue to STAT+ to read the full story…

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Pharma Mirror

MAY 7, 2021

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.

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Pharmaceutical Technology

NOVEMBER 8, 2022

Fulgent Genetics has acquired clinical-stage therapeutics development firm Fulgent Pharma for a total deal price of nearly $100m. According to the deal, the purchase price, contingent on adjustments, has to be paid by Fulgent Genetics as a combination of cash on hand and its shares of common stock.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 25, 2024

A woman in Colombia with rare genetic resistance to Alzheimer’s disease may have more company than scientists thought.

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Gene Genetics Scientist Research 245

XTalks

FEBRUARY 4, 2025

Related: FDA Approves New Use for Ozempic to Reduce the Risks of Kidney Disease Maze stands out in the biotech space with its Compass platform, which analyzes genetic data to identify disease-linked variants. For complex diseases like chronic kidney disease (CKD), where genetics play a significant role, such a platform holds promise.

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Clinical Trials Clinical Trials Trials Genetics 66

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 9, 2024

The convergence of gene therapies and clinical research is pushing the boundaries of what’s possible in ophthalmic care, offering hope for more effective treatments and potential cures for a range of vision-threatening conditions.

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Gene Therapy Gene Genetics Clinical Research 244

Advarra

FEBRUARY 4, 2025

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). Advarra convened a panel of experts to discuss practical solutions for balancing compliance with efficiency in clinical trial startups. Age isnt the only factor to consider.

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Clinical Trials Clinical Trials Trials Compliance 52

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

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Pharmaceutical Technology

JUNE 15, 2023

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Pharma R&D teams are solving this problem by leveraging the power of artificial intelligence (AI) in clinical trials to save time and money.

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Clinical Trials Clinical Trials Trials Development 130

Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. Still, the country’s clinical trials sector remains insular. Tracking the news.

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Clinical Trials Clinical Trials Trials Vaccine 306

XTalks

JANUARY 6, 2025

CF is a progressive genetic disease caused by defective CFTR proteins, which are crucial for regulating salt and water movement in cells. In clinical trials, Alyftrek demonstrated non-inferiority to Trikafta, showing similar improvements in lung function and a reduction in sweat chloride levels.

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Pharma Mirror

APRIL 28, 2021

Catalent will provide process development and CGMP manufacturing of AavantiBio’s adeno-associated viral (AAV) vector-based therapeutic candidate for use in clinical trials in the U.S. and Europe. Catalent will further support process optimization and look to reduce material.

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Pharmaceutical Technology

NOVEMBER 8, 2022

Cyagen and Neurophth Therapeutics have entered a strategic partnership to jointly develop next-generation AAV gene therapy vectors for specific kinds of genetic ophthalmic ailments. Additionally, Neurophth will oversee the clinical trials and marketing of gene therapy products developed leveraging the new AAV capsids of Cyagen.

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Gene Therapy Gene Development Genetics 305

Pharmaceutical Technology

MARCH 14, 2023

Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these. The vaccine has received approval for preventing dengue disease in people aged four years to 60 years.

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Vaccine Vaccination Clinical Trials Clinical Trials 286

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

A unique genetic mutation in two siblings – that has never been seen in anyone else – has been discovered by UK researchers at the University of Exeter, pointing the way towards new treatment options for type 1 diabetes. The mutation is in the gene for a protein called programmed death-ligand 1 (PD-L1), and a […]

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Gene Genetics Protein Research 243

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 22, 2024

Cancer is typically triggered by some kind of change to our genetic coding that interferes with a cell’s ability to manage its growth. (Richard Jones/Science Photo Library/Getty Images) Scientists have discovered hundreds of genes that could potentially promote cancer, new research shows.

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World of DTC Marketing

DECEMBER 29, 2020

These vaccines were developed using different “platform technologies” that involve slotting genetic material from the virus into a tried and tested delivery package. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. However, this is time-consuming.

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Vaccine Vaccination Development Clinical Trials 307

XTalks

MARCH 19, 2025

Elevidys is the first FDA-approved gene therapy for DMD a rare genetic disorder characterized by progressive muscle degeneration. To date, over 800 patients have received the therapy in clinical trials and real-world settings. It will update Elevidys prescribing information and adjust monitoring protocols as necessary.

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XTalks

DECEMBER 9, 2024

This initiative is particularly impactful for rare diseases and genetic disorders, where traditional endpoints may be infeasible. This shift not only prioritizes patient safety but also ensures that ineffective treatments are identified more quickly.

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Clinical Trials Clinical Trials Compliance Trials 105

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 25, 2024

Nature, 2024) Aging brings two opposing trends in cancer risk: first, the risk climbs in our 60s and 70s, as decades of genetic mutations build up in our bodies. Researchers studied cancer growth in mice. Zhuang et al., But then, past the age of around 80, the risk drops again and a new study […]

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Genetics Research Clinical Trials Clinical Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 16, 2024

(juanma hache/Getty Images) When we start to go gray depends a lot on genetics. Your first gray hairs usually appear anywhere between your twenties and fifties. For men, gray hairs normally start at the temples and sideburns. Women tend to start graying on the hairline, especially at the front.

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Genetics Clinical Trials Clinical Trials Trials 246

Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

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Gene Therapy Gene Development Genetics 264

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 1, 2024

While a domino effect of immunological reactions can be traced back to their genetic roots, a number of contributing factors are also involved, making it difficult to map the precise chain of […]

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Pharmaceutical Technology

SEPTEMBER 5, 2022

In March last year, CanSinoBIO obtained approval for the clinical trial application to analyse Convidecia Air. Administered as a single dose, the genetically engineered vaccine has the replication-defective adenovirus type 5 vector that expresses the spike S protein of the SARS-CoV-2 virus.

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Pharmaceutical Technology

JUNE 24, 2022

The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. The totality of preclinical, manufacturing and clinical trial findings that were submitted for analysis formed the basis for the EUA. The vaccine showed an encouraging safety and tolerability profile in both trials.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 7, 2023

New research from ETH Zürich in Switzerland could see future wearable devices (with perhaps a few implants and a touch of genetic engineering) boost our health directly. Fitness trackers help you stay healthy by keeping count of your steps and monitoring your heart rate, driving you on to hit those cardio goals.

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