clinical trials

Lilly announced results from its Phase 3 TRIUMPH-4 trial of retatrutide, a first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, on Thursday. In the efficacy-estimand analysis, participants taking the highest dose (12 mg) lost an average of 28.7% of their body weight at 68 weeks, about 71.2 pounds from a baseline of 248.5 pounds.…

In June 2025, the Food and Drug Administration rolled out Elsa, an agency-wide generative AI assistant that officials say is already helping to speed the review of new drugs and devices and shrink weeks of paperwork into minutes. It is a vision that could reshape how lifesaving therapies reach patients, but Elsa’s first six months…

Investors are pouring money into medical outpatient buildings just as pharma races to decentralize clinical research. The overlap is starting to look less like coincidence. When you look at the latest U.S. office numbers, it might appear that medical and pharmaceutical companies are retreating from real estate. Central business district towers are struggling with high…

Cary, North Carolina–based analytics stalwart SAS has launched SAS Clinical Acceleration, a cloud based software platform designed to help manage clinical trial data, analyze results and prepare regulatory submissions. The modular system combines a content repository with a statistical computing environment so clinical development teams can manage, analyze, report and review clinical and medical data…

The FDA approved Lynkuet (elinzanetant) 60 mg capsules for the treatment of moderate to severe hot flashes due to menopause last week. Lynkuet is reportedly the first and only dual neurokinin (NK) targeted therapy, as it is both a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist.  Filling the gap of nonhormonal treatment options…

Traditionally, clinical trials have relied on paper-based consent forms to obtain participant approval. But this approach creates significant challenges. Administrative staff may misplace forms or spend unnecessary time on repetitive consent procedures, and participants often struggle to understand complex medical terminology. As clinical trial models continue to evolve, particularly with the growth of decentralized and…

Static, one-size-fits-all clinical supply chains create waste, delay trial milestones and heighten compliance risk, pressures now intensified by the EU Clinical Trials Regulation. In response, biotechs are shifting from large safety stocks to flexible, data-driven, patient-centric models that pair real-time enrollment forecasting with agile labeling and regional depots. “The most critical KPI in a clinical…

COVID-19’s grip may have loosened, but its effects on pregnancies linger in data showing higher preterm birth risks for infected mothers. A new analysis from Panalgo, a Norstella company, presented at ICPE 2025, used linked U.S. claims data to match COVID-positive pregnant women against controls. The data revealed a statistically significant increase in preterm deliveries;…

Biomarkers are strategic assets for biopharma companies, significantly improving the success rate of clinical trials1. Yet, discovering them often feels like navigating through a blizzard of unstructured information, searching for the one true signal that can guide the way. While laboratory automation has eased benchwork, the real storm rages in the data, obscuring access to…

Healthcare is one of the largest sources of “big data,” accounting for upwards of 30% of all data produced globally.1 Early on, the potential benefits of this data for healthcare outcomes were immediately evident. As that promise has begun to materialize, with the advent of AI and machine learning, real signals of improvement in therapeutic…

A study from the Barcelona Institute for Global Health revealed that ivermectin, usually used to treat river blindness and scabies, can reduce malaria transmission. The BOHEMIA trial is the largest study on ivermectin for malaria, and results revealed that the pill reduced malaria by 26%.  As mosquitoes become more resistant to insect repellent and other…

Demand for next-generation GLP-1 drugs is fueling a boom in peptide research, prompting companies like Sai Life Sciences to expand capabilities amid a hot market for obesity and diabetes treatments. “The GLP-1 agonists have exploded the peptide field,” said Maneesh Pingle, Ph.D., executive vice president and head of discovery services at Sai Life Sciences, in…

Swissmedic has approved Novartis’ Coartem Baby as the first malaria medicine for newborns and young infants, the company announced on Tuesday. The treatment was developed in collaboration with the Medicines for Malaria Venture (MMV).  Novartis plans to distribute the treatment on a not-for-profit basis to areas where malaria is endemic. This includes the eight African…

Nektar Therapeutics’ (NKTR) stock has skyrocketed 287% over the past five days to $33.20 after its experimental drug rezpegaldesleukin hit all primary endpoints in a Phase 2b atopic dermatitis trial, prompting H.C. Wainwright to raise its price target to $120 from $6.50, a 1,746% increase. This represents one of the largest single-day gains in the…

Dupixent (dupilumab) has been approved by the FDA for the treatment of adult patients with bullous pemphigoid (BP), a chronic autoimmune skin disorder, Sanofi announced Friday. Dupixent is now approved to treat eight diseases with underlying type 2 inflammation and is the only targeted medicine for the treatment of BP.  FDA approval based on clinical…

Earlier this year, at the JP Morgan Healthcare conference, Regeneron CEO Leonard Schleifer referred to Dupixent (dupilumab), the fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, as “a pipeline in a single product.”  The drug, co-developed by Sanofi and Regeneron, is following a similar course to AbbVie’s…

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…

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…

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 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…

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,…

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,…

​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…

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…

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…