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Clinicaltrials are expensive, slow and often limited by outdated design constraints. They offer patient-specific outcome predictions, generated using machine learning models trained on real historical clinical data. Accelerating timelines and de-risking development decisions across the pipeline.”
Discovered by Daiichi Sankyo, I-DXd is being co-developed with Merck (known as MSD outside of North America) as part of a broader strategic collaboration between the two companies. Addressing a Pressing Clinical Need in Prostate Cancer Prostate cancer remains one of the most prevalent malignancies among men worldwide.
By accelerating timelines, anticipating challenges and alleviating bottlenecks, pharmaceutical companies and combined CDMO and CRO partners together can help ensure those potential treatments reach the patients who need them as efficiently as possible.
Clinical genomics, powered by NGS, enables more precise target validation, improved patient stratification and optimised trial design, ultimately aiming to increase PoS. For example, MLMs can simultaneously explore genetic sequences and clinical data to improve crucial characteristics such as efficacy, safety and bioavailability.
“Protocol development can be a complex and meticulous process,” he explains, “as it’s crucial to ensure that trial candidates meet the necessary inclusion criteria.” Prior treatments and patient histories often introduce variables that can affect outcomes, making thoughtful trial design essential for generating reliable data.
This study explored the effects of beginning treatment with lower starting doses of MariTide to improve tolerability while maintaining clinical benefit. Both data sets now provide foundational insight into the design and direction of Amgen’s upcoming Phase 3 MARITIME clinicaldevelopment program.
Ionis Begins Pivotal Phase 3 REVEAL Study of ION582 in Angelman Syndrome, Dosing First Patient in Global Trial Ionis Pharmaceuticals , Inc. This trial will build on previous positive data from the earlier Phase 1/2 HALOS study and is designed to rigorously assess the potential of ION582 as a disease-modifying therapy. “We
Novartis Finalizes Acquisition of Regulus Therapeutics, Strengthening Its Renal Disease Portfolio with Promising ADPKD Therapy Novartis AG, a leading global pharmaceutical company, has officially completed its acquisition of Regulus Therapeutics Inc. , a biotechnology firm known for its expertise in microRNA-targeting therapies.
Effective financial management is a cornerstone in the success of clinicaltrials, which are integral to the advancement of drug discovery. As the pharmaceutical and biotech industries continue to evolve, clinicaltrials become more complex, and the importance of robust financial oversight has never been clearer.
Arrowhead’s Subsidiary Visirna Transfers Greater China Rights to Plozasiran to Sanofi in Strategic $395 Million Deal Amid Regulatory Milestone in Hypertriglyceridemia In a move poised to reshape the therapeutic landscape for patients with severe lipid disorders in China, Arrowhead Pharmaceuticals , Inc. President and CEO of Arrowhead. “We
In just two years, CTMC has advanced eight therapies into clinicaltrials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies.
This partnership brings together Altasciences’ extensive expertise in preclinical research and early clinicaldevelopment with VoxCell’s groundbreaking tissue engineering technology, promising to deliver a more human-relevant, predictive, and efficient drug development paradigm.
Each target and each therapeutic modality induce varying degrees of clinical efficacy, as well as causing toxicities. Finally, while there are clear front runners among the pharmaceutical companies developing targeted therapeutics for these antigens there are also emerging biotechs aggressively pursuing these targets.
The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C., The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C.,
DT-7012 retains its depletion activity even in high CCL1-concentrated environments – an essential property not shared by most competitor antibodies currently in clinicaldevelopment.” The preclinical characterisation of DT-7012 has provided a strong foundation for its clinicaldevelopment,” says Schann.
This dual-pronged approach allows Revolution Medicines to access capital tailored to its evolving needs without relinquishing equity or ceding commercial rights to a larger pharmaceutical partner. Early data has demonstrated encouraging signs of efficacy and safety, and the company is planning to initiate pivotal trials in the near term.
Bayer and Tsinghua University Deepen Strategic Alliance to Advance Pharmaceutical Innovation in China Bayer and Tsinghua University (THU), two powerhouses in global pharmaceutical innovation and academic research, have announced a renewed commitment to their long-standing partnership.
This significant financial infusion is designed to fuel Revolution Medicines’ ambitious clinicaldevelopment and commercialization plans, with a particular focus on its groundbreaking RAS(ON) inhibitor programs for patients with RAS-addicted cancers.
Tom joined Abzena in 2023 and works within the protein engineering department working on pre-clinicaldevelopment of Antibody drug candidates. Dr Petra Dieterich Dr Petra has 30 years’ experience of drug development in the pharmaceutical industry with a focus on supporting CMC activities.
While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. Developing a new drug takes an average of 10–15 years and costs upwards of $2 billion, yet the majority of drug candidates fail before reaching regulatory approval.
JCR Pharmaceuticals Celebrates 50 Years of Innovation with Global Website Launch That Reflects Its Expanding Reach and Human-Centric Mission As JCR Pharmaceuticals commemorates its 50th anniversary, the global specialty biopharmaceutical company is marking this major milestone with the launch of a newly designed global website.
Drug-drug interactions (DDI) are a significant concern in clinicaltrials, where the safe and effective administration of drugs to patients is crucial. Challenges in Managing Drug-Drug Interactions in ClinicalDevelopment Predicting and managing DDI in clinicaltrials is one of the most complex challenges in drug development.
Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. This has sparked the development of a new approach to treating neuropsychiatric disorders.
Ibtrozi was approved based on a pair of trials showing response rates of 90% and 85%, respectively, in patients who hadn’t previously received another tyrosine kinase inhibitor. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG.
Each target and each therapeutic modality induces varying degrees of clinical efficacy, as well as causing toxicities. Finally, while there are clear front runners among the pharmaceutical companies developing targeted therapeutics for these antigens there are also emerging biotechs aggressively pursuing these targets.
ClinicalTrials: Pritelivir is currently in phase II clinicaltrials, with ongoing research into its effectiveness and safety. Pritelivir (development codes AIC316 or BAY 57-1293 ) is a direct-acting antiviral drug in development for the treatment of herpes simplex virus infections (HSV).
Groundbreaking Data from the Phase III ARANOTE Trial The CHMP’s recommendation is founded on data from the pivotal Phase III ARANOTE clinicaltrial, which demonstrated that darolutamide, when used in combination with ADT, significantly reduced the risk of radiological progression or death in patients with mHSPC.
A final lipophilicity adjustment led to the discovery of CDZ173 (leniolisib), a potent PI3K selective inhibitor with suitable properties and efficacy for clinicaldevelopment as an anti-inflammatory therapeutic. 2] [5] It is a kinase inhibitor [2] [6] that is taken by mouth. [2] mmol) in CH 2 CI 2 (100 mL), was added TFA (41.8
Daniel Galbraith, Chief Scientific Officer at Solvias , brings extensive expertise in the pharmaceutical and biotechnology sectors. In his role, he provides both strategic and technical guidance to Solvias, a global Contract Research Organisation (CRO) that offers critical analytical services to the pharmaceutical industry.
We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. Converting these challenges into opportunities, we must embrace new clinicaldevelopment strategies that promote agility, efficiency and effectiveness.
The drug’s clearance came after an unusual clinicaldevelopment journey and, in the ensuing months, has swelled Soleno’s market value past $4 billion amid optimism about the drug’s sales prospects. This database now covers the 50 best-selling pharmaceutical products and has been updated to reflect current patent expiry expectations.
Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. This expansion is creating opportunities for clinicaltrials related to a range of new therapy areas and their subpopulations.
Dive Insight: Lexeo is developing treatments for heart conditions, such as cardiomyopathy associated with Friedreich’s ataxia and plakophilin-2 arrhythmia. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.
Drug patents are a form of intellectual property protection that grants pharmaceutical companies exclusive rights to manufacture, sell, and profit from their innovations for a set period. Types of Patents in the Pharmaceutical Industry Not all patents are created equal.
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As clinicaldevelopment of an investigational product proceeds, Sponsors often conduct global clinicaltrials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region.
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Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.
This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinicaltrials.
Dr. Ken Kobayashi, CMO, ASLAN Pharmaceuticals, commented: “The emerging safety profile of ASLAN004 has allowed us to move directly into the expansion cohort at the highest dose, 600mg weekly, based on blinded safety data, accelerating the completion of the study.
SINGAPORE, Jan. Media and IR contacts. Forward looking statements.
Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s ClinicalTrials Nexus, I had the privilege of representing Worldwide ClinicalTrials as the sole CRO on a panel discussion: “Reversing the Conversation: What the ClinicalTrial Industry Really Wants from its Service Providers.”
The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinicaldevelopment should emphasize sensitivity over specificity in CNS effects. Tags ClinicalTrials Weight 12 View the Driving Simulation Fact Sheet for more information.
With significant validation of our platform in hand, we are now rapidly advancing towards the clinic with our lead therapeutic, OSK. We hope to initiate the first human clinicaltrials with our lead indications in 2025, which would represent a monumental step forward for the field of cellular rejuvenation.
Prior to joining Gannex, Dr. Palmer was Head of Liver Disease ClinicalDevelopment at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs.
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