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Digital transformation has much to offer lifesciences as well as healthcare — and the synergies between the two can further optimize the power of digital health, clinicaltrials and patient outcomes.
Despite advancements in neuroscience and psychiatry, clinicaltrials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges. One of the main challenges lies in defining and selecting appropriate trial populations.
Global rare disease clinicaltrials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. ClinicalTrial Manager/Sr. These measures enhance recruitment, retention and overall trial success.
The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinicaltrials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinicaltrials.
Biotechnology company Tiziana LifeSciences has revealed plans to assess intranasal foralumab as a potential treatment for long Covid. Tiziana LifeSciences chief medical officer Matthew Davis said: “We anticipate entering into a Phase 2a placebo-controlled clinicaltrial upon successful feedback from the FDA.
The same is true in lifesciences. As the technology develops, however, it will offer more opportunities to expedite drug discovery processes, streamline clinicaltrials, and speed up regulatory approvals. MGI puts the value of this contribution to clinical development at $15 billion to $25 b illion.
Federation of Asian Biotech Associations’ (FABA) LifeSciences Innovation Cluster is now working to strengthen the global partnerships to propel an ecosystem for novel biologics and diagnostics.
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 clinicaltrials holding great hope for the treatment of challenging and uncurable diseases.
The Indian lifesciences sector is making strides by integrating quantum computing, artificial intelligence (AI), machine learning (ML), advanced analytics, big data, internet of things (IoT) and blockchain into their research and development efforts.
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 clinicaltrial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinicaltrial designs.
BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinicaltrial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7
As the Union Budget approaches, the lifesciences sector anticipates substantial support to enhance innovation and investment in the development of new chemical entities (NCEs) and new biological entities (NBEs). The lifesciences sector in India has shown remarkable resilience […]
This Act is poised to significantly change the clinicaltrials landscape within the lifesciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.
This year, Camargo is highlighting one of our own, Manager of LifeScience 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 clinicaltrial. And I started researching trials.
This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”
The expansion will also contribute to building the province of Ontarios position as a global hub for lifesciences and biotechnology. Additionally, AstraZeneca anticipates seven first Phase III clinicaltrial data readouts in 2025.In The acquisition was one of the largest research investments in a Canadian biotech firm.
Clinicaltrials 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%
Experts in the life-sciences industry are of the view that doing away with human studies for new drugs in India is unscientific and risky as patients here have different anthropometry.
mg), underperformed in its latest clinicaltrial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. Novo shared the latest data from the Phase III REDEFINE 2 trial evaluating the drug in overweight or obese patients with type 2 diabetes.
Changes taking place in the United States and internationally may affect the clinicaltrials landscape in the months and even years to come. … The post Keeping ClinicalTrials on Track: Navigating Supply Chains, Tariffs, and Regulatory Shifts. appeared first on Imperial Clinical Research Services Blog.
Anavex LifeSciences has secured new US intellectual property compositions patent for its ANAVEX 2-73 (blarcamesine). The patent number 11,661,405 has been issued by the US Patent and Trademark Office (USPTO) and is expected to remain effective until October 2036.
Current Share Price: The announcement follows a $115 million Series D financing in December 2024, co-led by Frazier LifeSciences and Deep Track Capital, with participation from Janus Henderson Investors and Logos Capital. The Phase I trial showed promising safety and pharmacokinetics. for an upfront payment of $150 million.
Dr. Manson Brown’s Clinical Development and Scientific Innovation team are responsible for global clinicaltrial development strategy for the Aesthetic Medicine portfolio, covering pharmaceuticals and device. Subscribe to the Xtalks LifeScience Podcast to never miss a new episode.
Stay up to date with the latest news in the lifesciences industry with highlights from clinicaltrials involving CSL, Arcturus, Sanofi, Nexviazyme, and REGENXBIO from the week of 5th to 9th February 2024.
Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinicaltrial complexity. It’s important to make sure that with this increase in clinicaltrial complexity, we don’t make our trials overly burdensome to sites or patients,” says Markham.
In this episode, Vera spoke with Morgan Hanger, Executive Director of the ClinicalTrials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinicaltrials, with an ambitious “Transforming Trials 2030” vision.
In the lifesciences sector, one country is significantly outstripping others for FDI. Data shows that almost 40% of all lifesciences subsidiaries are located in the US. After all, around a third of the world’s leading lifesciences corporations have their headquarters in the country. Industry clusters.
GSK has entered a strategic partnership with Wave LifeSciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. On completion of the first-in-patient clinicaltrial by Wave, GSK will be in charge of the development and marketing works.
Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8
As advancements in research forge ahead, it is imperative to ensure patients are informed about and can access potentially life-saving clinicaltrials. Tell us about your recent work regarding colorectal cancer clinicaltrials. How does the Colorectal Cancer Alliance support clinicaltrials for colorectal cancer?
Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinicaltrials or need to start planning to include.
Recruiting participants is perhaps the most challenging aspect of any clinicaltrial, 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 ClinicalTrials For All?
In the dynamic world of lifesciences, 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 LifeSciences Cloud marks a significant stride towards this goal.
The landscape of rare disease clinicaltrials 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.
The push to increase diversity in clinicaltrials has gained momentum, but true progress requires more than regulatory mandates. In this webinar, industry leaders and patient advocates discussed how authenticity and the patient voice can be leveraged to enhance diversity in clinicaltrials.
Clinicaltrial manager jobs are vital for the development and execution of clinicaltrials, 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 clinicaltrial managers.
The FNIH recently announced that the AMP Bespoke Gene Therapy Consortium has selected eight rare diseases for its clinicaltrial portfolio. Xtalks spoke with Dr. Silverthorm about the consortium’s new rare disease clinicaltrial portfolio. Subscribe to the Xtalks LifeScience Podcast to never miss a new episode.
Most of us have heard of ChatGPT and AI but where and how do they fit into the lifesciences 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 lifesciences and medicine, in particular.
In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Participants received either rilzabrutinib or placebo for 24 weeks, followed by an open-label extension.
Over the next 12 months, the company expects to transition two or three other compounds into clinicaltrials. As part of Series B financing, Goldman Sachs Asset Management LifeSciences Investment head Amit Sinha and Lyell Immunopharma president and CEO Lynn Seely will join the board of managers of TORL BioTherapeutics.
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 clinicaltrial portfolio. As such, rare disease patients and their families often face little hope for effective treatments.
As we step into 2024, the lifesciences 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. These companies are at various stages of research and clinicaltrials.
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