A growing chorus of experts agree: 2025 signals a year when AI and its generative variants (genAI) move beyond early experimentation into a period of tangible, large-scale impact — including in the life sciences. While challenges remain as EY recently noted, the future will likely be one where the focus shifts from anticipating breakthrough genAI…
FDA drug approvals holding steady at 44 YTD in 2024
YTD 2024 FDA approvals: By the numbers 44 Novel Drug Approvals As of December 5, 2024, the FDA had approved a total of 44 novel drugs, spanning a diverse array of therapeutic areas and patient populations. These new treatments address both widespread public health concerns, such as cardiovascular disease and COPD, and more narrowly defined…
Biotech in 2025: Precision medicine, smarter investments, and more emphasis on RWD in clinical trials
In 2025, genetic validation is poised to emerge as a high-stakes litmus test in cardiovascular R&D, investors will continue to get better at funneling cash into proven science, and patients will continue their evolution to become more-active partners shaping their healthcare. To hear more about each of these trends, we considered feedback from three industry…
External comparator studies: What researchers need to know to minimize bias
Randomized controlled trials (RCTs) are the gold standard design for studies supporting drug approvals, but they are not always feasible, due to factors such as ethical concerns or very small patient populations. When an RCT is not possible, researchers may opt for a single-arm trial (SAT), which does not include an internal control group, but…
Genomics in 2025: How $500 whole genome sequencing could democratize genomic data
As we edge closer to 2025, advances in long-read sequencing technologies, increasing biobank participation, and a growing emphasis on pharmacogenomics are all set to transform how we diagnose, treat, and prevent diseases. Below, Neil Ward, VP of Pacific Biosciences (PacBio) EMEA, offers insights on what’s happening now—and what’s next—as genomics and precision medicine finally deliver on their promise…
Tiny breaths, big impacts: Bridging the gap between laboratory discoveries and clinical applications in breath research with mouse models
The understanding that there is a connection between breath and diseases can date back to over two thousand years ago, when Hippocrates described fetor oris and fetor hepaticus in his report on breath aroma (1). Since then, research into volatile organic compounds (VOCs) exhaled in breath and their involvement in disease physiology has led to…
PROTACs in focus: Navigating the complexities of preclinical development
The development of Proteolysis Targeting Chimeras, or “PROTACs*,” has garnered significant attention in the pharmaceutical industry due to their potential to target and degrade disease-causing proteins previously considered undruggable. As a novel therapeutic modality, PROTACs offer a promising alternative to traditional small-molecule inhibitors and biologics. However, despite the excitement around these therapies, preclinical evaluations of…
Xaira Therapeutics bolsters leadership team and relocates headquarters to fuel AI-powered drug discovery
Xaira Therapeutics, an AI-driven biotechnology startup that emerged earlier this year with a $1 billion funding round, continues to demonstrate its ambitions and staying power. Despite recent biotech industry turbulence, with some AI-focused biotech firms announcing layoffs and restructuring, Xaira has doubled down on growth. The firm is bolstering its leadership roster while announcing a…
Tirzepatide shows 47% greater weight loss than semaglutide in 72-week phase 3b study
A phase 3b open-label randomized clinical trial (SURMOUNT-5) has shown that tirzepatide leads to greater weight reduction compared to semaglutide in adults with obesity or overweight conditions. The study from Eli Lilly demonstrated a mean weight loss of 20.2% with tirzepatide (Zepbound) versus 13.7% with semaglutide (Wegovy) over a 72-week period. Last year, a pre-print…
Why FSP outsourcing of clinical operations roles is surging—and how to optimize your partnership
As the complexity, sophistication, and size of clinical trials have grown exponentially, the need for specialized expertise—often spanning various regions around the globe—has also expanded, along with the demand for flexible staff allocation. Consequently, clinical operations staffing has undergone significant transformations in recent years. The trend has shifted from relying on direct internal hires, to…
Transforming pharmacovigilance with GenAI for faster, safer drug approval
As we approach the second quarter of the 21st century, speed is a driving force in the pharmaceutical environment. The industry currently faces a critical challenge in drug lifecycle management: how to accelerate drug safety monitoring while sticking to stringent safety and regulatory standards. Traditional methods of processing safety cases—essential for tracking adverse effects and…
From biology-first AI to structured digital twin adoption, 4 shifts coming to biopharma R&D in 2025
In 2023, the composite success rate for clinical development in biopharma hit its highest level since 2018 thanks to the adoption of novel trial designs, predictive biomarkers, and digital methodologies, according to IQVIA. But waning R&D productivity is a significant industry concern. A substantial number of life science executives believe their organizations need to rethink…
Beckman Coulter debuts automated clone screening system claiming 90% reduction in manual steps
Beckman Coulter Life Sciences has announced a new automated clone screening platform for biologic drug development. The Cydem VT system integrates several established technologies — microbioreactor arrays, liquid handling, and analytical measurements — into a single platform capable of monitoring up to 96 parallel bioreactors. The system provides continuous monitoring of pH, dissolved oxygen, and…
Navigating the landscape of cell and gene therapy development: Insights from the FDA’s new FAQ
The U.S. Food and Drug Administration (FDA) recently released a draft guidance titled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” This 40-page document, while not legally binding, offers insights into best practices for common questions received by the Office of Therapeutic Products (OTP). While each question is answered in brief, the…
Why scientific AI needs clear lines of sight — especially for fields like drug development
Today’s large language models can be as unreliable as they are eloquent. Their tendency to fabricate facts and lose the thread makes them risky tools for scientific research, especially in highly regulated industries like pharmaceuticals and chemistry. They also struggle to provide sources and will fabricate a bogus academic journal without batting an eye. Speaking…
Sanofi commits €1 billion to build new insulin site in Beijing
Sanofi announced its largest-ever investment in China, committing €1 billion ($1.04 billion) to establish a new insulin production facility in the Beijing Economic and Technological Development Zone. This strategic manufacturing expansion represents a calculated response to China’s growing diabetes crisis, with recent data indicating 140 million adults living with diabetes as of 2021. The new…
Fulfilling the promise of genetic medicine: New approaches to overcoming old challenges
The field of gene therapy has seen unprecedented growth in recent years, with 20 approved indications in the U.S., a record number of approvals in 2023, and a rapid expansion of investigational trials across various diseases. Great strides have been made in potential treatments for inherited and acquired genetic diseases, including hemophilia B, sickle cell…
2024: The year AI drug discovery and protein structure prediction took center stage—2025 set to amplify growth
The global AI drug discovery market, valued around $1 to $1.7 billion in 2023, will be worth a multiple of that by the decade’s end. Analysts project the sector could be worth $9 billion or more. 2024 Nobel Prize in Chemistry Recipients: David Baker Demis Hassabis John Jumper Achievement: Computational protein design and structure prediction…
Drug development in 2025: 5 expert predictions cover synthetic data, hybrid trials and more
In 2024, we saw the expanded use of synthetic data and natural language processing transform drug discovery and development. In a batch of predictions published in December of 2023, one expert predicted that synthetic data was set to “take off” in drug research. In 2025, the pendulum could begin swinging back the other way, according…
PathAI launches AI tool for analyzing fibrosis in cancer tissue samples
The digital pathology firm PathAI has released PathExplore Fibrosis, an AI-based tool that analyzes fibrosis and collagen structures from H&E-stained whole-slide tissue images. The software quantifies fibrotic areas and collagen fibers from standard pathology slides, replacing specialized staining techniques and microscopy equipment. The tool processes large datasets of tissue images, designed to work with existing…
Projecting the top 20 Big Pharma firms of FY2024
The pharmaceutical industry’s traditional hierarchy continues to face dynamic shifts among the leaders. While Merck ($63.9B) and Pfizer ($62.5B) hold the top spots, double-digit growth from AstraZeneca (~18%), Eli Lilly (~34%), Novo Nordisk (~26%), and Amgen (~18%) signals an accelerating transformation in the sector’s competitive landscape. The continued strength of the GLP-1 market continues to…
Optimizing Data Pipelines in Life Sciences with AI-Driven Integration and FHIR
Sponsored by Infor. Data management in life sciences is inherently complex. Data is fragmented across multiple systems — such as clinical trials, lab systems, regulatory databases, and electronic health records (EHRs) — in inconsistent formats. For example, patient information in the EHR is typically transferred using legacy technology. Additional data streams from wearable devices,…
Accelerating life sciences with AI
This case study is sponsored by Infor. Artificial intelligence can revolutionize clinical interoperability by building bridges across data silos. Machine learning’s vast analytical capabilities enable the comprehensive analysis of large volumes of historical data from multiple sources, providing a more holistic view of patients’ overall health. Its ability to uncover patterns and anticipate future needs…
Advancing Clinical Trials and Research
This case study is sponsored by Infor. In the complex landscape of clinical trials and medical research, data fragmentation remains a major obstacle, hindering progress and patient outcomes. The case study “Advancing Clinical Trials and Research with Cloverleaf” showcases how Infor Cloverleaf significantly enhances clinical trials by integrating Real-World Evidence (RWE) to overcome data fragmentation.…
3-year study: Tirzepatide prevents diabetes in almost 99% of prediabetic adults
Although Lilly has shared the topline results of the SURMOUNT-1 trial, now, the full data from the three-year study have been published in the New England Journal of Medicine. The company also recently presented the data at ObesityWeek in San Antonio. The biggest conclusion was that 98.7% (752 of 762) of participants who received tirzepatide…