The FDA has approved zoliflodacin, a single-dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older, Innoviva announced on Tuesday. The oral antibiotic inhibits type II topoisomerase, a bacterial enzyme crucial to bacterial function and reproduction. What laid the groundwork for FDA’s zoliflodacin approval The FDA…
FDA approved ENFLONSIA for the prevention of RSV in Infants
Merck announced yesterday that the FDA has approved ENFLONSIA (clesrovimab-cfor), a preventive monoclonal antibody, for the prevention of RSV lower respiratory tract disease in newborns and infants entering their first RSV season. ENFLONSIA is the only RSV preventative option that is administered with the same 105 mg dose regardless of the patient’s weight. It is…
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones
Just over three-quarters, 76%, of patients receiving Sanofi and Regeneron’s Dupixent (dupilumab) achieved at least a 75% improvement in overall disease severity (EASI-75), the primary endpoint of the DISCOVER Phase 4 study. The study, presented at the Revolutionizing Atopic Dermatitis Conference in Nashville, focused on patients with moderate-to-severe atopic dermatitis with skin of color. Unmet…
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
Labcorp says it can now move tumor slides at internet speed instead of parcel speed. The diagnostics giant today rolled out a Leica-scanner–based digital-pathology network across its central labs and paired it with new next-generation-sequencing panels and homologous-recombination-deficiency (HRD) testing, a package the company claims will dramatically accelerate biomarker screening for oncology studies, with the potential to significantly…
Lokavant’s Spectrum v15 uses AI to cut trial-feasibility modeling from weeks to minutes
In an industry where each lost day can drain roughly $40,000 in direct clinical-trial costs, Lokavant says its newly launched Spectrum v15 can crunch data from 500,000 past studies and deliver enrollment forecasts in five minutes, work that typically takes study teams five weeks. The company claims that the platform boasts 80+% confidence. The company,…
Unlocking ‘bench-to-bedside’ discoveries requires better data sharing and collaboration
One of the biggest frustrations for anyone involved in clinical research or patient care is the continued challenges of advancing pre-clinical research into a clinical trial. Likewise, finding and recruiting ideal clinical trial participants for each trial phase, such as those with rare conditions or whose current health condition matches stringent clinical trial inclusion criteria,…
How biosimulation and virtual trials can bust through clinical trial roadblocks
Over 300 million people worldwide live with a rare disease, yet roughly 95% of these conditions lack an FDA-approved treatment. Traditional clinical trials face significant challenges in this segment. Barriers include small patient populations with correspondingly limited statistical power. Yet emerging biosimulation and virtual trial methods offer a promising path forward., says Oxana Iliach, vice-chair…
Complexity’s counterpoint: Understanding protocol optimization
In recent years, the clinical research landscape has been marked by a steady rise in protocol complexity with more endpoints and procedures across all trial phases and therapeutic areas. This trend, driven by the increasing sophistication of trial designs, is evident across trial phases and major therapeutic areas. Resulting in more endpoints and procedures on…
How an engineered algae-based biologic aims to break the annual $5B cycle of c. diff reinfection
Imagine a shape-shifting pathogen invisible to the naked eye, armed with toxin-laced barbs that rupture human cells. This isn’t fiction—it’s Clostridioides difficile, a superbug causing 29,000 U.S. deaths annually through severe diarrhea and colitis. After an initial infection, up to 35% of patients experience recurrence, with subsequent episodes becoming increasingly likely—up to 60% of these…
NVIDIA allies with IQVIA, Mayo Clinic and Illumina on healthcare AI
NVIDIA today announced at JP Morgan partnerships with IQVIA, Illumina, Mayo Clinic and Arc Institute that center on accelerating biomedical AI across genomics, drug development, and clinical diagnostics. The collaborations aim to tap advanced computing across the healthcare sector, with IQVIA deploying AI agents for clinical trials, Illumina integrating genomic analysis tools, Mayo Clinic developing…
QuantHealth bolsters leadership to accelerate enterprise-grade clinical AI
Tel Aviv-based QuantHealth is on a roll. In August 2024, it surpasses the 100th mark in simulated clinical trials with an 85% accuracy rate and reported cost savings upwards of $215 million for one major pharmaceutical partner. In March of the same year, Fast Company recognized QuantHealth as one of the most innovative companies in…
Merck taps Atropos Health to accelerate real-world evidence generation
Building on existing integrations with cloud leaders AWS and Google Cloud and collaborations with Arcadia and TD2, Atropos Health is now partnering with Merck. This new collaboration will tap Atropos Health’s GENEVA OS (Generative Evidence Acceleration Operating System) and related tools with the aim of speeding the generation of real-world evidence. Under the agreement, Merck’s…
Oracle exec maps data integration strategy for modern clinical trials in 2025 and beyond
From FHIR-based APIs to “hybrid data models” and blockchain-enabled audit trails, biopharma companies are exploring a range of strategies in their quest to incorporate Real World Data (RWD) into clinical trials. But technology alone won’t resolve the deeper issues at play. From bridging disparate data sources to safeguarding patient privacy under evolving regulations, sponsors face…
How a ‘rising tide’ of inclusivity is transforming clinical trials
Let’s say there’s a Black female patient with an aggressive form of breast cancer. She meets with her oncologist to discuss a promising targeted therapy that recently won FDA approval. The drug showed strong efficacy in clinical trials, with a 65% response rate. Yet when she asks about efficacy data specific to Black women, she…
TAK-279, an oral small-molecule TYK2 inhibitor offering the convenience of a once-daily pill and biologic-like clinical responses
To the untrained eye, psoriasis might look like a simple skin condition, marked by itching, scaly patches. Yet psoriasis is an immune-mediated disease with systemic consequences. As Dr. Graham Heap, vice president and global program leader at Takeda, explained during a recent interview, “Psoriasis might manifest as plaques on the skin, but it’s an immune…
By 2025, clinical research and patient care converge: Data integration, validation, and evolving markets
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…
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…
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…
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…
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…
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…
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…
Unlearn on shaving millions off clinical trial budgets with digital twins
Clinical trials are notoriously expensive, with Phase 3 studies costing upwards of around $55,000 per day and completed trials routinely costing in the tens of millions of dollars. The startup Unlearn aims to chip away at those costs using digital twin technology, a concept pioneered by NASA during the Apollo era to create ‘living models’…