Worldwide Clinical Trials

JANUARY 6, 2025

Through the implementation of full automation in bioanalytical testing PK, immunogenicity, and biomarker assays we streamline trials, reduce costs, save time, and maintain the highest data quality standards. Biomarkers support adaptive trial designs, allowing modifications based on interim results to optimize study outcomes.

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Clinical Trials Clinical Trials Trials Genetics 130

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. Crenessity marks the third approved drug for Neurocrine.

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Genetics Hormones Trials Drugs 116

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 7, 2024

When research tells us that our grandparents’ diets can affect our health decades later, it can be hard to shake the feeling that genetics spells out the trajectory of our wellbeing. But how much of our health is actually determined by our genes, and what effect does our lifestyle have, for better or worse? Can […]

Genetics 245

Genetics Gene Research Clinical Trials 245

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 13, 2023

Now an international team of researchers has discovered a new genetic variant in people of African ancestries that appears to restrict HIV replication after an infection sets in. A tiny fraction of people are naturally resistant to HIV infections, and scientists want to understand why.

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Genetics Scientist Research Clinical Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 21, 2022

Scientists have found an extremely subtle twist in the genetics of aging cells, one that seems to make them increasingly less functional as time goes on.

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Genetics Gene Scientist Research 239

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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Research Clinical Trials Clinical Trials Immune Response 147

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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Research Clinical Trials Clinical Trials Immune Response 130

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.

Genetic Disease 189

Genetic Disease Genetics Gene Editing Medicine 189

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

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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Clinical Trials Clinical Trials Gene Marketing 130

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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Clinical Trials Clinical Trials Trials Dermatology 130

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

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). While the trial waits for approval, patients who are eager for a new treatment face delay. Language relating to the potential cost of participation.

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Clinical Trials Clinical Trials Trials Compliance 52

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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Genetics Drugs Clinical Trials Clinical Trials 188

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!

Genetics 130

Genetics Clinical Trials Clinical Trials Genotype 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

DECEMBER 9, 2024

The new framework allows the FDA to require confirmatory trials to be underway before or shortly after approval, potentially reducing the time to confirm a therapys clinical impact from several years to as little as two or three years.

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Clinical Trials Clinical Trials Compliance Trials 105

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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Genetics Drugs Clinical Trials Clinical Trials 141

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.

Gene Therapy 105

Gene Therapy Protein Genetic Disease Gene 105

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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Gene Therapy Gene Genetics Clinical Trials 80

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

JUNE 25, 2024

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

Gene 245

Gene Genetics Scientist Research 245

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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Vaccine Vaccination Clinical Trials Clinical Trials 263

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

MAY 16, 2023

Clinical trials for pulmonary fibrosis are being conducted to evaluate the effectiveness of novel therapies and interventions, providing hope for improved outcomes in the future. Clinical trials are investigating the use of stem cells in improving lung function and quality of life for pulmonary fibrosis patients.

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Clinical Trials Clinical Trials Trials Research 98

XTalks

JULY 29, 2024

Participant recruitment is challenging, especially in those indications in which there are competing clinical trials necessitating a comprehensive understanding of the disease research ‘landscape’ and targeted outreach and stakeholder collaboration. Read on to learn key lessons in rare disease drug development.

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Clinical Trials Clinical Trials Trials Research 105

XTalks

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio. Of the more than 10,000 rare diseases, more than 80 percent are caused by genetic defects.

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Gene Therapy Clinical Trials Clinical Trials Gene 98

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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Genetics Development Genome Genomics 130

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

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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Vaccine Vaccination Genetic Engineering Clinical Trials 264

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

STAT News

JULY 26, 2022

The Food and Drug Administration has agreed to review a treatment for a rare, genetically defined form of ALS developed by Biogen, even though results from a clinical trial failed to show a definitive benefit for patients. Biogen said Tuesday that U.S.

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Clinical Trials Clinical Trials Trials Genetics 98

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.

Gene Therapy 130

Gene Therapy Genetic Disease Genetics Gene 130

pharmaphorum

SEPTEMBER 7, 2022

Pharma has a great opportunity ahead of it when it comes to conducting representative clinical trials. The processes used are now seeing huge infrastructure commitments, in order to cement their place in the development of future products and trials. But our drug development processes are not perfect.

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Clinical Trials Clinical Trials Trials Genetics 98

FDA Law Blog

NOVEMBER 10, 2024

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. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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Production Clinical Development Development Regulation 69

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