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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, clinical trials and patient outcomes.
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 clinical trial upon successful feedback from the FDA.
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.
Denali’s medicine and a similar one from Calico LifeSciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.
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.
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.
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.
Cloudbyz’s inclusion in this respected benchmark report underscores its dedication to advancing clinical trial management through robust, innovative technology designed to optimize data collection, ensure regulatory compliance, and streamline trial processes. “We
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.
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.
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. These systems must undergo thorough conformity assessments to verify their compliance with safety, transparency, and accountability standards, thereby boosting the reliability and integrity of clinical trial data.
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 clinical trial by Wave, GSK will be in charge of the development and marketing works.
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.
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.
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.
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.
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.
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. Novo shared the latest data from the Phase III REDEFINE 2 trial evaluating the drug in overweight or obese patients with type 2 diabetes.
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.
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.
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.
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.
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.
Dr. Manson Brown’s Clinical Development and Scientific Innovation team are responsible for global clinical trial development strategy for the Aesthetic Medicine portfolio, covering pharmaceuticals and device. Dr. Brown is co-chair of the Aesthetics Pharmaceutical Governance Board at AbbVie and is the co-founder of the Science of Aging.
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.
The growth in sales was driven by all regions and business sectors, particularly LifeScience. to €10.38bn in its LifeScience business during the year. The EBITDA pre of LifeScience grew by 14.4% Merck has reported an increase in group net sales by 12.9% to €22.23bn in fiscal 2022 against €19.68bn in 2021.
VDRs may be used for asset sales, audit tenders, bankruptcies, due diligence processes, mergers & acquisitions, public and private debt and equity capital raising, clinical trials, and organisational restructuring. The post Virtual data room use for lifesciences M&A deals rising appeared first on Pharmaceutical Technology.
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.
The drug is the only natural THC-based investigational drug undergoing FDA trials. Ram and Claudia spoke about the compound, including clinical data from the ongoing trials evaluating it. Subscribe to the Xtalks LifeScience Podcast to never miss a new episode.
The candidate is currently being evaluated in Phase II and Phase III clinical trials. Subscribe to the Xtalks LifeScience Podcast to never miss a new episode. To hear more about ProKidney’s cell therapy for chronic kidney disease, including developmental, manufacturing and regulatory considerations, tune into the episode.
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. Baker McDowell, Head of Regulatory Strategy.
Led by Bain Capital LifeSciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management. It decreased vitamin A dimerization by more than 80% and prevented blindness in a genetic animal model of the disease in preclinical trials.
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.
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.
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.
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.
He is responsible for evidence portfolio across two therapeutic indications, chronic kidney disease and heart failure, encompassing seven active trials and studies and more than 3,000 US patients. Subscribe to the Xtalks LifeScience Podcast to never miss a new episode.
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.
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.
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