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Looking ahead, 2025 could represent a major turning point for the pharmaceutical sector. These twins simulate how a patients condition might evolve without treatment, enabling researchers to compare the real-world effects of an experimental therapy against predicted outcomes.
By Leah Eisenstadt July 24, 2025 Credit: CDC/ Frederick A. However, finding those regulators of viral infection using existing methods has been difficult and is especially challenging for the most dangerous viruses like Ebola that require stringent high-containment biosafety protocols. Patten at Boston University.
2024 has been a year of growth and evolution in clinical research. As we look to 2025, Advarra thought leaders have compiled predictions and perspectives on key topics shaping the industry. As AI continues to evolve, its ability to transform the efficiency, quality, and scalability of clinical research will grow exponentially.
Persistent challenges with NHP use Despite their biological relevance, using live NHPs in research poses several major challenges: Ethical concerns NHPs, due to their advanced cognition and social behaviour, are at the centre of ongoing ethical debates. Supply chain disruptions Availability is a critical bottleneck in NHP-based research.
There will also be a poster award for early-career professionals recognising the research that the next generation of scientists bring to drug discovery. After PhD and postdoctoral work in the UK and Singapore, Prof Johnson received a prestigious Ramn y Cajal fellowship at the Centre for Genomic Regulation (Barcelona).
New technology puts a spatial lens on CRISPR screening By Leah Eisenstadt March 12, 2025 Breadcrumb Home New technology puts a spatial lens on CRISPR screening Perturb-FISH reveals impacts of perturbations on gene expression and phenotype with single-cell, spatial resolution, allowing study of effects within and between cells.
Merck, Bristol-Myers Squibb, Amgen, Eli Lilly, and Gilead have all conducted microgravity research in orbit. With respect to the latter, Mercks microgravity research on Keytruda is an informative case study. Despite the progress made, microgravity research projects to date have been exploratory, small-scale one-offs.
Scientists create next generation of tools in battle against brain disease By Corie Lok May 21, 2025 Breadcrumb Home Scientists create next generation of tools in battle against brain disease The findings contained in eight studies could lead to targeted gene therapies for brain disorders. Ben-Simon et al.) and striatum ( Hunker et al.
Current challenges in CNS drug development Drug development for the CNS is particularly challenging and researchers face several hurdles to producing effective and safe treatments, many of which are unique to the CNS. Researchers must carefully select a serotype for AAVs.
Multimodality however can detect and connect trends (and in future generate content) across different modalities and therefore allows for better interpretability, which builds trust between regulators, researchers and industry stakeholders. The Rise of Multimodal Language Models in Drug Development (2025).
In March 2025 , Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. Eastern Time on June 25, 2025. Now that the transaction is finalized, Novartis will begin the process of fully integrating Regulus’ operations, research assets, and staff into its own global structure.
Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
Foundation, explained during the EULAR 2025 presentation: “IgG4-related disease is a progressive, immune-mediated condition with a significant unmet patient need. This design was meant to enable clinician-researchers to gauge the ability of rilzabrutinib to control disease activity after the withdrawal of standard therapy.
Traditionally, CAR T therapy has been confined to large academic or research hospitals due to its complexity. This growing body of evidence has given regulators the confidence to reduce restrictions, a decision that aligns with the evolving standard of care in oncology and cell therapy.
All these features make GPCRs central to regulating many vital biological processes in the body, including immune responses and inflammation, and thus especially attractive for therapeutic intervention. It also holds potential for neuroinflammatory conditions such as certain types of migraine.
The data underscored the significant clinical benefits associated with cystic fibrosis transmembrane conductance regulator (CFTR) modulators—particularly its next-generation triple therapy, ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor).
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).
By Broad Communications June 24, 2025 Credit: Casey Atkins David Liu is a core member at the Broad Institute where he is the Richard Merkin Professor and director of the Merkin Institute for Transformative Technologies in Healthcare. My lab's contribution was developing the base editing technology that made it possible to correct K.J.'s
In 2016, researchers František Baluška and Stefano Mancuso suggested that ocelli could also explain Boquila ’s uncanny shape-shifting ability, positing that these “tiny eyes” may actually be capable of sight. Such vascular differences are governed by auxin, a plant hormone that regulates leaf venation and shape.
Members of the PI3K family regulate cellular processes such as cell growth and proliferation, survival, remodelling, and intracellular transport of organelles. [15] Retrieved 17 April 2025. January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. 3 November 2006. 3 November 2006.
Understanding the Medications Involved: Semaglutide’s Growing Role in Global Health Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) , a class of drugs that has gained substantial popularity over recent years for its efficacy in blood glucose regulation, weight reduction, and cardiovascular risk management.
A survey of healthcare and life science companies found that 93% of these companies expect to increase their spend in 2025. These councils bring together diverse expertise from scientists and researchers, data analysts and technology specialists, regulatory compliance experts, as well as commercial operations leaders.
Researchers have since discovered variants of the protein with additional useful qualities. Researchers have also discovered a slew of small Cas9s — some less than half the size of the S. By cutting DNA with CRISPR, researchers can therefore scramble the genetic code in a way that disables the targeted gene.
The data, presented at the annual European Alliance of Associations for Rheumatology (EULAR 2025) congress in Barcelona, Spain, show that dapirolizumab pegol resulted in significant and clinically meaningful improvements in disease activity while addressing a major symptom that profoundly impacts patients’ daily lives — fatigue.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025. This priority review designation reflects the transformative potential of WINREVAIR for patients living with PAH,” said Dr. Joerg Koglin , Senior Vice President of Global Clinical Development at Merck Research Laboratories.
The results of this study were presented at the American Association for Cancer Research (AACR) annual meeting on April 27, 2025, and show a dramatic improvement in event-free survival (EFS) for patients treated with KEYTRUDA alongside standard care. 0.89; p = 0.00140). “As
Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. Its clearance was a milestone, coming after decades of painstaking research, but also controversial, as the evidence Sarepta compiled in support didn’t prove a clear benefit on patients’ motor function.
billion by 2025, growing at a CAGR of 34.2% from 2020 to 2025[1]. Similarly, the European Medicines Agency (EMA) has been at the forefront of biosimilar regulation, with a well-established approval process in place since 2006. billion by 2025, driven by patent expirations and the need for cost-effective treatments.
Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. How regulators will interpret and enforce its provisions may not become clear for some time.
Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co. logo displayed on the exterior of their research facility in San Francisco, Calif., Tsai said he doesn’t expect any risks to the deal from antitrust regulators at the Federal Trade Commission. Alamy Merck & Co.
Our experts are closely monitoring eight healthcare trends that are shaping industry leaders’ strategies in 2025. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. And this year is especially interesting, as 2024’s U.S. billion by 2030.
government could do until the 1938 Federal Food, Drug, and Cosmetic Act gave authority to the FDA to regulate drugs. Researchers have solved cryo-EM structures showing ATP synthase in multiple different conformations. ” Asimov Press (2025). Still, there wasn’t much the U.S. Today, few remember DNP. Cite: Telford, A.
Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. On June 26, 2025, the Food and Drug Administration eased some of the medicines' reporting requirements. BCMA and CD19 are the protein targets of the seven approved CAR-T therapies.
Lenz, Principal Medical Device Regulation Expert & Lisa M. For non-AI-enabled devices, the early feasibility research may not directly affect the development process, i.e., the final, finished device can be fully developed, transferred to a controlled manufacturing environment, and tested under a design controls process.
Senator Dick Durbin (D-IL) expressed concerns over the agencys ability to regulate direct-to-consumer (DTC) prescription drug advertisements following recent workforce reductions. By Charles D. Snow & Dara Katcher Levy In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. Healthier populations are more productive.
Our experts are closely monitoring eight healthcare trends that are shaping industry leaders’ strategies in 2025. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. And this year is especially interesting, as 2024’s U.S. billion by 2030.
On the last day of February every year is Rare Disease Day , a dedicated day to celebrate the rare disease community, including patients, families, caregivers, clinicians, researchers, regulators, and more. The goal is to build community, share ideas and resources, and advance research and innovation.
Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices. By Steven J. Gonzalez & Allyson B.
WHO Maintains Global Health Emergency Status for Mpox Amid 2024 Surge, Issues Strengthened Recommendations In response to the continuing resurgence of mpox across several regions in 2024, the World Health Organization (WHO) convened the fourth meeting of the International Health Regulations (2005) Emergency Committee on 5 June 2025.
The UK’s Advanced Research and Invention Agency (ARIA) is often referred to as a “UK DARPA” While ARIA is no DARPA clone, many features of the agency are admittedly DARPA-inspired, such as the use of term-limited program managers, which ARIA calls program directors. But often, that would be a loss for ARIA.
Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: Whats Next for Retail Pharmacy: Data, Debate, and Disruption This event will be broadcast live on: Friday, June 20, 2025 12:00 p.m. It is part of The Drug Channels 2025 Video Webinar Series.
The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities. Ongoing trials must transition to the EU CTR by Jan.
Published July 22, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds, iTeos Therapeutics and Roche that you may have missed. and European life sciences companies.
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