Clinical research - Today Stories

DeepHow has introduced PharmaCloud, a cloud-based platform designed specifically for pharmaceutical and medical device manufacturers to improve training, execution, and verification on the factory floor. PharmaCloud provides a GMP-compliant environment that helps teams standardize procedures across sites so operators follow approved methods with greater consistency and fewer errors than traditional training. The platform unifies training content, guided step-by-step execution, and AI-powered verification to ensure critical process steps are completed correctly and according to validated procedures. PharmaCloud also tracks changes and training records so teams always work with current, approved instructions and maintain full audit trails. By bringing visual guidance and AI feedback into dai…

Sanofi has secured European Union approval for Teizeild (teplizumab), a new disease-modifying therapy for people aged eight years and older with stage 2 type 1 diabetes. This decision by the European Commission follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and makes Teizeild the first treatment in the EU shown to delay the onset of stage 3 clinical type 1 diabetes. The approval is based on positive results from the TN-10 phase II study, where Teizeild significantly extended the time patients remained in the presymptomatic stage compared with placebo, effectively slowing progression of the autoimmune attack on insulin-producing cells. Sanofi says the drug offers patients and families a chance to postpone the need for insulin t…

QPS Holdings, LLC, an award-winning contract research organisation focused on clinical trials and bioanalysis, has implemented the Oracle Argus Safety Database to elevate its pharmacovigilance capabilities. This industry-leading safety case management system will support QPS in capturing, managing and reporting adverse event data across clinical trials with greater efficiency and compliance. By adopting Argus, QPS aims to improve patient safety oversight, strengthen regulatory compliance and streamline safety reporting workflows for sponsors. The move reflects QPS’s commitment to operational excellence and advanced technology integration as drug development becomes increasingly complex and data-intensive. Oracle Argus is widely recognised as a comprehensive pharmacovigilance solution that…

PSI CRO has broadened its footprint in Canada by opening a new office in the Toronto area and naming an experienced industry leader to guide its operations there. The office, located in Mississauga, Ontario, builds on the company’s established Canadian presence and commitment to clinical research excellence. PSI CRO has been active in Canada for over a decade, supporting complex clinical trials with a focus on dependable delivery and strong relationships with research sites. As part of this expansion, David Allen, MBA, has been appointed as Country Manager for Canada. Allen brings more than 30 years of experience in clinical research from both sponsor and CRO environments. In his new role, he will lead efforts to enhance the company’s operational capabilities in the local market and ensure…

GlaxoSmithKline announced that the US Food and Drug Administration has approved its twice-annual asthma therapy Exdensur, offering a new option for patients aged 12 and older with severe eosinophilic asthma inadequately controlled by standard treatment. Exdensur, known by its active ingredient depemokimab, is designed as an add-on maintenance treatment that can be administered just twice a year, potentially improving convenience and adherence for patients living with persistent symptoms. The decision follows positive clinical evidence showing significant reductions in asthma exacerbations and hospital visits when added to existing therapies, underscoring its potential impact on this patient population. GSK expects Exdensur to complement current biologics and become an important part of its…

The Publishing group behind the science magazine New Scientist, has closed its dedicated job portal New Scientist Jobs. The site, once a key place for employers to post science and research-oriented vacancies is no longer operating. This however cements PharmiWeb.jobs position as the primary dedicated job board for Life Sciences in Europe. Recruiters and Hiring Managers   Any organisations looking to promote their vacancies with the broadest reach to Life Science professionals across Europe, the USA and Australasia can reach out to PharmiWeb here - https://phrmwb.com/exnewscientistjobs  Job Seekers If you're a job seekers looking for your next Life Science role, PharmiWeb.jobs remains the best place to look - So if if you've not already, register and upload your CV for the best roles. www.…

The Swiss drugmaker Novartis has secured U.S. regulatory approval for Itvisma (onasemnogene abeparvovec-brve), a gene replacement therapy for individuals aged two years and older with Spinal Muscular Atrophy (SMA) and a confirmed SMN1 mutation. Itvisma represents the first one-time gene therapy available for a broader SMA population beyond infants. The treatment delivers a functional copy of the SMN1 gene via an injection into the spinal fluid, eliminating the need for weight-based dosing. Clinical trials demonstrated statistically significant improvements in motor function and stabilization of disease progression. Novartis emphasises that this approval could reduce or even eliminate the requirement for chronic therapy in older patients. With this milestone, Itvisma becomes a major extensi…

The UK government has announced a sweeping package of reforms and investment designed to put artificial intelligence at the centre of the country’s economic renewal. The measures include billions of pounds in additional funding and new initiatives aimed at supporting UK businesses, researchers and workers. Key elements of the plan include the creation of new “AI Growth Zones” such as one in South Wales which is expected to bring in more than 5 000 jobs over the next decade, including roles from construction to long-term AI research. Free access to computing resources will be expanded so British researchers and start-ups can train new AI models and deliver breakthroughs in science and industry. A dedicated “Sovereign AI Unit” will be backed with nearly £500 million to support high-potential…

Global life sciences company Bayer has unveiled its new “Science Delivers” campaign, designed to highlight how science shapes everyday life and fosters progress across society. Launched on World Science Day, the initiative includes a wide-reaching advertising push, a public “Declaration on Science,” and interactive experiences that invite people to share personal stories of how science has made a difference in their lives. A central video montage showcases individuals in diverse settings while a voiceover narrates how scientific discovery powers medical breakthroughs, cleaner water, sustainable agriculture, and better energy solutions. The message is clear: for every community and for every tomorrow, science truly delivers. The campaign also features installations and a digital hub where p…

Thermo Fisher Scientific has entered into a definitive agreement to acquire Clario Holdings, Inc., a leader in endpoint data solutions for clinical trials, in a transaction valuing Clario at approximately US$8.9 billion in cash, with additional performance-based payments possible. The acquisition is expected to close by mid-2026, subject to regulatory approvals and customary closing conditions. Clario’s platform collects and analyzes clinical trial data from devices, sites and patients thereby enabling sponsors to derive deeper insights and make faster decisions.  Thermo Fisher says the move will strengthen its offerings for pharmaceutical and biotech customers seeking to accelerate drug development and bring therapies to patients more efficiently.  In financial terms the deal is expecte…

Novartis has announced that its oral complement-factor B inhibitor Fabhalta® (iptacopan) has met the primary endpoint of the Phase III APPLAUSE‑IgAN study in adults with IgA nephropathy (IgAN). In the final analysis of the trial, patients receiving Fabhalta showed a statistically significant improvement in the annualised slope of estimated glomerular filtration rate (eGFR) decline compared with placebo over two years, indicating slowed kidney-function deterioration. According to Novartis, Fabhalta is the first and only approved complement inhibitor for adult IgAN and the new data support its potential to delay disease progression. The study included adults with biopsy-confirmed primary IgAN who had proteinuria and were on maximally tolerated renin-angiotensin system inhibitors with or with…

Innovative technology platform reshapes how sponsors, CRO, and clinical sites manage complex clinical trials at scale   Almac Group has today announced a $48 million investment in eClinical technologies that includes the launch of Almac Trial Coordinator™ – a first-in-class interoperable clinical trial technology platform, enhancements to its eClinical ecosystem capabilities, and creation of over 100 advanced technology roles globally. This investment addresses the top technology challenges facing sponsors, CROs, and clinical sites through the solution’s market-disrupting and interoperable approach to integration, enabling high-quality, efficient trials with full visibility, reduced risk, and enhanced patient engagement.   Almac Trial Coordinator™ is purpose-built to unify operational proc…

Discovery Park in Sandwich, Kent, has announced the launch of a new specialist sixth form for science-focused students aged 16 to 18. Named Carbon 6 Academy of Science, the school will open in September 2026 and will deliver a dedicated STEM curriculum. Located within the Discovery Park innovation campus, Carbon 6 will give students direct access to professional laboratories and real-world scientific environments. The academy will offer A-levels in Biology, Chemistry, Physics and Mathematics, with options for Further Maths and an Extended Project Qualification. Students will benefit from close connections to the science and pharmaceutical companies based at Discovery Park, gaining opportunities for mentoring, guest lectures, and research placements. The programme is designed to prepare lea…

AI-native biotech startup expands to Oxford to develop predictive models for safer, faster drug discovery Fukuoka, Japan – October 3, 2025 – Tres Alchemix, a cutting-edge biotechnology company applying artificial intelligence (AI) to drug discovery, has closed a $4.4 million Series A funding round (approx. ¥650 million JPY), led by DNX Ventures, with support from Waseda University Ventures. The funding will fuel the development of Tres Alchemix’s human in silico drug-design platform, a technology that integrates multi-omic datasets, quantum-chemical calculations, and AI modeling to simulate drug interactions in the human body. This enables direct predictions of both therapeutic effects and potential adverse reactions, dramatically improving the speed and safety of early drug discovery. The…

University College London is leading a new clinical trial called ADAPT (Alzheimer’s Disease Diagnosis and Plasma p-tau217) that could transform how Alzheimer’s is diagnosed in the UK. The trial centres on a blood test that detects a protein marker p-tau217, which reflects the build-up of amyloid and tau proteins in the brain, two key hallmarks of Alzheimer’s disease. The goal is to see whether this test can increase diagnostic accuracy from around 70 percent with current clinical assessments to over 90 percent. Over 1,000 people with suspected dementia will be recruited from about 20 NHS memory clinics. Participants will be randomised into two groups: half will receive results within three months, the other half after 12 months. Researchers will examine whether earlier feedback improves di…

Novartis announced it will acquire Tourmaline Bio for approximately $1.4 billion, offering $48 per share, a significant premium over recent stock prices. The acquisition will provide Novartis access to pacibekitug, a promising anti-inflammatory drug candidate nearing Phase III trials for atherosclerotic cardiovascular disease. Both companies’ boards have approved the deal, and Novartis will initiate a tender offer to acquire all outstanding shares. The acquisition is expected to close in the fourth quarter of 2025, after which Tourmaline will become an indirect, wholly owned subsidiary of Novartis. The move bolsters Novartis’ growing cardiovascular disease portfolio and aligns with its broader strategic focus. Analysts see the timing as logical, given recent strong Phase 2 data for pacibek…

Clerkenwell Health has launched the UK’s first fully NHS‑embedded commercial research site dedicated to brain and mental health, in partnership with Rotherham Doncaster and South Humber NHS Foundation Trust (RDaSH). Located within an existing NHS facility in Doncaster, the site serves over 1.3 million people across South Yorkshire. This initiative offers NHS patients quicker access to cutting‑edge investigational treatments while addressing long‑standing delays that have discouraged global sponsors from conducting trials in the UK. By utilising underused NHS infrastructure and collaborating closely with NHS clinicians, the site also creates local jobs, enhances research capability through upskilling, and boosts workforce development. Rather than a pilot, it is the first in a planned nation…

United Therapeutics recently announced that its pivotal TETON-2 clinical trial of nebulized Tyvaso (treprostinil) inhalation solution for idiopathic pulmonary fibrosis achieved its primary endpoint. The study revealed a significant improvement in absolute forced vital capacity compared with placebo. Encouraging results were also seen across most secondary endpoints, such as time to first clinical worsening and quality of life measures. Strong outcomes from TETON-2 are intended to support a supplemental New Drug Application to the US Food and Drug Administration for an expanded indication in IPF. The company also intends to consult with the FDA later this year to explore opportunities to accelerate regulatory review. Additionally, more detailed findings are expected to be shared at the upco…

The National Institute for Health and Care Excellence has approved a novel first‑line treatment for adults with unresectable or metastatic urothelial cancer who are eligible for platinum-based chemotherapy. The regimen combines enfortumab vedotin (Padcev) with pembrolizumab (Keytruda) and is now available on the NHS in England and Wales. Clinical trials revealed that the new combination nearly doubled progression‑free survival—from 6.3 to 12.5 months—and extended overall survival dramatically, with median overall survival reaching 33.8 months compared to 15.9 months with chemotherapy alone. Around 30 percent of patients had no detectable cancer after treatment, markedly higher than rates seen with traditional chemotherapy. Oncology experts have hailed the development as a transformational…

Roche, together with its partner Alnylam, is propelling the RNA interference therapy zilebesiran into a Phase III cardiovascular outcomes trial following compelling Phase II results. At the European Society of Cardiology Congress 2025, data from the KARDIA‑3 study were presented. While the trial did not meet its primary endpoint due to statistical constraints, the 300 mg dose achieved a placebo‑adjusted systolic blood pressure reduction of 5 mmHg at Month 3 (p = 0.0431), with sustained benefits through Month 6. Safety data were encouraging, and subgroup analysis suggested enhanced benefit when zilebesiran was combined with a diuretic. The comprehensive insights from the KARDIA‑1 through KARDIA‑3 studies guided the decision to launch a global Phase III cardiovascular outcomes trial, targete…