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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. One of the main challenges lies in defining and selecting appropriate trial populations.
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.
Two drugs developed by Wave LifeSciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.
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 […]
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 clinical trial data readouts in 2025.In The acquisition was one of the largest research investments in a Canadian biotech firm.
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.”
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 clinical trial. The clinical advancement follows a thorough review of Phase I trial data under the FDAs Regenerative Medicine Advanced Therapy (RMAT) designation.
Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis.
Global rare disease clinical trials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. Clinical Trial Manager/Sr. These measures enhance recruitment, retention and overall trial success.
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.
This Act is poised to significantly change the clinical trials 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.
GSK has entered a strategic partnership with Wave LifeSciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. The discovery alliance, with a preliminary research period of four years, will aid GSK in progressing up to eight programmes and Wave to develop up to three programmes.
The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Nicola Owen, PhD, MBBS, Medical Directorthey shared insights into the operational and medical strategies that support the design and conduct of MASH clinical trials.
The same is true in lifesciences. As the technology develops, however, it will offer more opportunities to expedite drug discovery processes, streamline clinical trials, and speed up regulatory approvals. A Blueprint for Adoption in Clinical Trials That’s where large integrated site organizations come in.
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
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.
LifeSciences Council. Do you know about the LifeSciences Council (LSC)? The LSC has a website on Gov.uk, but the page says LifeSciences Council. A post from the director of health and lifesciences at Innovate UK, Richard J Hebdon, also bigged up the news before the Council met about four health missions.
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.
From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables lifesciences teams to collaborate efficiently and effectively in 2023. Patient choice will push sponsors toward operational excellence.
In this episode, Vera spoke with Morgan Hanger, Executive Director of the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinical trials, with an ambitious “Transforming Trials 2030” vision.
The lifescience 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.
Optum LifeSciences expert provides insights on the latest trends. Optum LifeSciencesresearchers stay up-to-date on the latest in research and how it may affect access for patients. Given the population level impact, what are researchers studying now?
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.
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 clinical trials.
Most of us have heard of ChatGPT and AI but where and how do they fit into the lifesciences ecosystem? Over the next two years, GlobalData’s thematic research unit shows further advancements in machine learning, falling into three main categories: technology, macroeconomic, and regulatory. Can AI transform document translation?
OncoImmune was founded in 2000 based on the scientific discoveries of the company’s founders who moved their lead product from a basic concept into clinical trials for multiple indications. Subscribe to the Xtalks LifeScience Podcast to never miss a new episode.
With just under a week left before Theranos founder Elizabeth Holmes is set to begin her 11-year prison sentence, the former CEO has appealed her conviction, calling it ‘unjust,’ asking for a new trial or a reduced prison term. Holmes founded healthcare startup Theranos in 2003.
This includes new Phase III trial data for Kerendia (finerenone) in patients with heart failure that was presented recently at this year’s European Society of Cardiology (ESC) Congress 2024. Tune into the episode to hear more about the latest trial data for finerenone in heart failure and the landscape of heart failure research.
Courtney Silverthorn PhD, the associate vice president of translational sciences at the FNIH, said that the BGTC plans to “bring some more standardisation and clarity to the pathway of how you get an AAV gene therapy into a first-in-human clinical trial [for rare diseases].”
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 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. The UK lifesciences industry is clearly in need of support.
The company plans to use these funds to advance its groundbreaking research in small molecule precision medicines, targeting renal, cardiovascular and metabolic diseases, including obesity. The Phase I trial showed promising safety and pharmacokinetics. Maze initiated the Phase I trial in 2024, with results expected in 2025.
Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinical trials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.
Aviceda Therapeutics (Aviceda) has entered into a strategic partnership with the Patrick G Johnston Centre for Cancer Research at Queen’s University Belfast (QUB) for the development of next-generation glyco-immune therapeutics. The company strengthens the translational research collaboration between the US and Ireland.
The landscape of rare disease clinical trials 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. Improving diversity in clinical trials has become a key priority in recent years.
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 clinical trial. You aren’t thinking about treatments and trials.
Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. The 400 mg dose was the highest lepodisiran dose in the trial.
Although some lifesciences companies are starting to shift to incorporate human-centered design practices, it is often coming late in the drug development process – well into the commercialisation efforts of launch planning, if not post-launch. gain insights to inform trial design and optimal target product profiles.
This variability not only poses challenges for diagnosis but also stresses the need for targeted research and innovative therapeutic approaches. By exploring rare diseases and focusing on HPP, we can better understand the complexities of genetic disorders and the need for patient-centric research and collaboration.
In this interview, Craig Lipset, Co-Founder of the Decentralized Trials & Research Alliance, discusses the Alliance’s new glossary for industry and more. The global virtual clinical trials market is valued at $8.3 Today organizations have been stabilizing their approaches for decentralized research. billion by 2030.
XTALKS WEBINAR: Redefining Womens Cancer Care: Delivering Smarter, Safer Clinical Trials Live and On-Demand: Thursday, April 10, 2025, at 11am EDT (4pm BST/UK) Register for this free webinar to explore innovative approaches to enhancing clinical trials for breast and gynecological cancers.
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Building on this history of success, Novocure recently revealed promising Phase III results from the PANOVA-3 clinical trial, marking a significant milestone in pancreatic cancer treatment. Novocure’s broader pipeline underscores the versatility of TTFields therapy.
Despite its potential to slow cognitive decline, the delays highlight the challenges of timely drug approval for life-threatening conditions. Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits.
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