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

Pharmaceutical Technology

JUNE 2, 2023

Anavex Life Sciences has secured new US intellectual property compositions patent for its ANAVEX 2-73 (blarcamesine). Anavex’s orally available drug candidate restores cellular homeostasis by targeting sigma-1 and M1 muscarinic receptors.

Life Science 130

Life Science Clinical Trials Clinical Trials Trials 130

Pharmaceutical Technology

DECEMBER 14, 2022

GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. On completion of the first-in-patient clinical trial by Wave, GSK will be in charge of the development and marketing works.

Life Science 162

Life Science Development Gene Therapy Genetics 162

Velocity Clinical Research

MARCH 23, 2025

Clinical trials have been steadily leaving the UK for years. of patients recruited to global trials were from the UK. Thats not to say we dont still have some clout (the UK ranks fourth globally for Phase II trials ), but the trending outflow needs to be addressed. In 2021, just 2.2% Whats Causing the Outflow?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

XTalks

FEBRUARY 14, 2023

The life science industry is constantly evolving, making it difficult to stay ahead of the curve. There’s no doubt that pharmaceutical and biotechnology organizations are utilizing innovative technology solutions across all sectors of drug development, research and development, supply chain, manufacturing and more.

Life Science 98

Life Science Clinical Trials Clinical Trials Development 98

Camargo

NOVEMBER 22, 2021

This year, Camargo is highlighting one of our own, Manager of Life Science Solutions Andrea Miller, who cared for her husband Tom throughout his battle with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. We wanted to participate in a clinical trial. And I started researching trials.

Clinical Trials 198

Clinical Trials Clinical Trials Trials Research 198

XTalks

DECEMBER 20, 2023

As we step into 2024, the life sciences continue to evolve at an unprecedented pace, driven by technological innovation, a deeper understanding of human biology and the application of new technologies in areas like drug development and health wearables.

Life Science 119

Life Science Gene Editing Development Clinical Trials 119

XTalks

MARCH 14, 2025

Novo Nordisks investigational obesity combination drug, CagriSema (a fixed dose combination of cagrilintide 2.4 mg), underperformed in its latest clinical trial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. mg and semaglutide 2.4

Trials 89

Trials Drugs Clinical Trials Clinical Trials 89

XTalks

DECEMBER 4, 2024

In this episode, Ayesha spoke with John Yu, MD, CEO of Kairos Pharma , a company advancing therapies to overcome challenges in cancer drug resistance and immune suppression. Kairos is developing therapeutics that reverse cancer drug resistance in cancers such as prostate and lung cancer. Dr. Yu has also led numerous clinical trials.

Drugs 59

Drugs Life Science Clinical Trials Clinical Trials 59

Cloudbyz

MARCH 17, 2024

In the dynamic world of life sciences, where innovation is paramount, the integration of cutting-edge technologies is crucial for accelerating clinical operations and driving breakthroughs in healthcare. Salesforce’s recent announcement of its Life Sciences Cloud marks a significant stride towards this goal.

Life Science 81

Life Science Clinical Trials Clinical Trials Trials 81

Pharmaceutical Technology

JANUARY 22, 2023

However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. Major pharmaceutical acquisitions have taken place in recent months in the rare disease space, as the number of orphan drug approvals continues to grow. This was not always the case. “Up

Drugs 317

Drugs Gene Hormones Clinical Trials 317

Pharmaceutical Technology

APRIL 14, 2023

The first-in-class, clinical-stage antibody-drug conjugate (ADC) targeting Claudin 6 (CLDN 6), TORL-1-23 is being developed to treat patients across several cancer types. The lead drug programmes of the company target CLDN 6 and Claudin 18.2 CLDN 18.2). It intends to advance one or two new compounds each year.

Development 264

Development Clinical Trials Clinical Trials Life Science 264

Pharmaceutical Technology

JUNE 20, 2023

Most of us have heard of ChatGPT and AI but where and how do they fit into the life sciences ecosystem? AI-powered solutions in healthcare While the impact of AI will be far-reaching, its pattern-matching abilities and processing speed means AI has the potential to revolutionise the field of life sciences and medicine, in particular.

Life Science 130

Life Science Clinical Trials Clinical Trials Regulation 130

XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

XTalks

JUNE 14, 2023

The FNIH recently announced that the AMP Bespoke Gene Therapy Consortium has selected eight rare diseases for its clinical trial portfolio. Xtalks spoke with Dr. Silverthorm about the consortium’s new rare disease clinical trial portfolio. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Gene Therapy 98

Gene Therapy Life Science Gene Clinical Trials 98

XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. It’s very positive and it’s going to help move forward the pathway for new drugs.”

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

XTalks

AUGUST 23, 2023

BriaCell is developing cell therapies for the treatment of advanced breast cancer and has promising compounds, including Bria-IMT, that are currently being evaluated in clinical trials. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 98

Life Science Clinical Trials Clinical Trials FDA Approval 98

XTalks

JANUARY 8, 2024

Getting a drug to market used to be a relatively simple and straightforward affair. Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. That’s just not the case anymore.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Gene Therapy 105

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Regulation 100

pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Data will unlock clinical and economic value in Europe’s challenging landscape.

Life Science 111

Life Science Development Research Production 111

XTalks

NOVEMBER 28, 2024

Axsome Therapeutics has released findings from its ENCORE Phase III trial, demonstrating that their investigational drug AXS-12 (reboxetine) significantly reduces cataplexy attacks, improves excessive daytime sleepiness and enhances overall functioning in individuals with narcolepsy. weekly cataplexy attacks compared to 10.29

Clinical Trials 103

Clinical Trials Clinical Trials Trials Regulation 103

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?

Clinical Trials 97

Clinical Trials Clinical Trials Trials Clinical Research 97

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.

Gene Therapy 98

Gene Therapy Clinical Trials Clinical Trials Gene 98

XTalks

NOVEMBER 14, 2024

PTC Therapeutics has gained US Food and Drug Administration (FDA) approval for its new gene therapy, Kebilidi (eladocagene exuparvovec), for treating aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi has a known safety profile from clinical trials. for this purpose.

Gene Therapy 105

Gene Therapy FDA Approval Gene Clinical Trials 105

Pharmaceutical Technology

APRIL 10, 2023

The HALOS platform is built using an invention from the research team led by Professor Chris Scott, who is the scientific co-founder and chief scientific officer of Aviceda and interim dean of research, faculty of medicine, health, and life sciences, at Queen’s.

Development 259

Development Life Science Clinical Trials Clinical Trials 259

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

Pharmaceutical Technology

APRIL 18, 2023

Acadia Pharmaceuticals has announced the commercial launch of its Rett Syndrome drug Daybue (trofinetide). The FDA approved the drug based on positive Phase III data from the Lavender trial. Daybue is an oral innovator drug that is a synthetic analogue of IGF-1, a growth factor produced in the brain.

Drugs 255

Drugs FDA Approval Clinical Trials Clinical Trials 255

XTalks

JULY 28, 2022

July is Disability Pride Month in the US and Bristol Myers Squibb has teamed up with the non-profit Disability Solutions to improve disability diversity in clinical trials. This initiative can pave the way for better accessibility and inclusion of people with disabilities in clinical trials.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

pharmaphorum

OCTOBER 28, 2022

The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. Could this candidate demonstrate clinical efficacy?

Life Science 105

Life Science Production Development Drugs 105

XTalks

DECEMBER 20, 2022

While clinical trials are becoming more complex, oncology trials have generally had a greater level of complexity than trials in many other disease spaces. Despite this, the number of oncology trials worldwide has increased dramatically over the past two decades. Regulatory Considerations.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Regulation 97

Cloudbyz

MARCH 1, 2023

Clinical trials are a critical component of drug development in the life sciences industry. Conducting clinical trials requires significant investments of time and resources, including the management of budgets and payments.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

XTalks

DECEMBER 22, 2022

Neilan has contributed to the rare disease community through his comprehensive work in the rare disease space that has included research, academia, medical practice and clinical trial design and execution. Can you tell us a bit about the work you are doing at NORD and how it impacts clinical trials for rare diseases?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

Gene Therapy 105

Gene Therapy Protein Genetic Disease Gene 105

Pharmaceutical Technology

NOVEMBER 3, 2022

Emalex Biosciences has raised Series D funds worth $250m led by Bain Capital Life Sciences to progress the development of an investigational new drug for Tourette syndrome. Headache, somnolence, fatigue, insomnia and restlessness were found to be the most common adverse events linked to ecopipam in the trial.

Development 130

Development Drugs Clinical Trials Clinical Trials 130

XTalks

APRIL 11, 2025

By preventing VEGF from binding its receptors on blood vessel linings, the drug cuts off tumors oxygen and nutrient supply. Clinical trials further demonstrated Jobevnes comparable performance in treating glioblastoma, renal cell carcinoma and advanced cervical and ovarian cancers. CAGR through 2033.

Antibody 104

Antibody Marketing Clinical Trials Clinical Trials 104

pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. How can this data be incorporated into clinical trials?”. He explains that there existed an unmet need to bolster the data sets for drug development.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Development 111

XTalks

DECEMBER 3, 2024

This technology, already approved by the US Food and Drug Administration (FDA) for glioblastoma and mesothelioma , and most recently for metastatic non-small cell lung cancer (NSCLC), harnesses electric fields to disrupt cancer cell division.

Trials 105

Trials Immune Response Clinical Trials Clinical Trials 105