Clinical trials are drowning in data. In a TransCelerate/Tufts analysis published in late 2025, phase 3 protocols averaged more than 5.9 million data points, up 67% since 2020. The researchers found that nearly one-third of procedures and associated data were non-core or non-essential. In other words, a good portion of this data does not directly…
STEERLife’s FragMelt platform manufactures drugs with heat sensitive active ingredient
Bionpharma announced Wednesday the FDA approval of its etravirine tablets, an HIV therapy developed in partnership with STEERLife. The therapy was developed using STEERLife’s proprietary FragMelt continuous processing platform, which enables a sustainable, solvent-free manufacturing process. Precise control: how FragMelt works with heat-sensitive drugs Etravirine is extremely sensitive to heat and shear forces, meaning traditional…
S&P report highlights Big Pharma’s concentration risk amid pre-JPM deal flurry
Merck is an A+ credit, a global oncology powerhouse, and still, about half its 2024 pharma revenue came from a single product: Keytruda, a product whose loss of exclusivity will hit around 2028 in the U.S. S&P Global Ratings calls that kind of concentration a “material weakness.” Merck isn’t alone. A new S&P analysis of…
Lilly Phase 3b trial shows roughly 40-fold higher combined arthritis and weight-loss response
Treating obesity may directly improve psoriatic arthritis outcomes, according to Phase 3b data released Wednesday by Eli Lilly. In the TOGETHER-PsA trial, patients receiving both Zepbound (tirzepatide) and Taltz (ixekizumab) showed a 64% relative improvement in arthritis disease activity compared to those on Taltz alone. The findings suggest obesity treatment directly improves psoriatic arthritis disease…
Drug companies sign “Most Favored Nation” deals, then raise prices anyway
Drug prices are one of the rare points of overlap between President Joe Biden and President Donald Trump: both have said Americans pay too much. And they do. U.S. patients pay more than three times what people in other developed nations pay for brand-name drugs, even after accounting for rebates, according to a 2024 RAND…
New gonorrhea antibiotic could treat resistant infections
Neisseria gonorrhoeae, the bacterium that causes the sexually transmitted disease (STD) gonorrhea, has developed resistance to many of the antibiotics that are used to treat it. Most patients with gonorrhea take a drug called ceftriaxone, a third-generation cephalosporin antibiotic, but resistance to that is growing. Recently, doctors have found two potential antibiotics that could treat…
Why Schedule III cannabis could be a win for Big Pharma
Fifty years of restricted research may be coming to an end. Reports that President Trump plans to direct cannabis rescheduling would finally open federally-funded clinical trials for cannabinoid therapeutics, and force the industry to answer questions it’s long avoided. Pharma companies like Jazz (Epidiolex) and AbbVie already have cannabinoid programs. This could accelerate M&A or…
Platelet-inspired nanoparticle delivers drugs directly where they are needed
Researchers at Case Western Reserve University and Haima Therapeutics used a “platelet-inspired nanoparticle” to deliver an anti-inflammatory drug. The drug was designed to improve the performance of electrodes in brain-computer interface (BCI) technology, which allows people to control devices with their thoughts. The nanoparticle allowed the scientists to deliver the drug directly to where the…
Lilly’s triple agonist delivers up to 71.2 lbs of weight loss in Phase 3 trial
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.…
China’s biopharma sector enters ‘innovation 2.0’ era
Western drug executives long treated China as little more than a sales target. Think more than a billion potential customers, a gold mine for revenue, but nothing special in terms of fresh ideas. Lately, that thinking has changed fast. China now ranks as the world’s second-biggest pharmaceutical market. The country’s sales hit $112.8 billion in…
The FDA’s AI ambitions depend on better data practices
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…
Outpatient clinics are becoming critical Infrastructure for drug trials
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…
SAS launches clinical trial analytics software built on its Viya cloud native analytics platform
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…
Bayer’s Lynkuet approved by FDA for menopausal hot flashes
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…
How stereo-correct data can de-risk AI-driven drug discovery
In drug discovery, the difference between a breakthrough and a breakdown can be as small as the twist of a bond. Stereochemistry, the three-dimensional arrangement of atoms, governs how otherwise identical molecules behave in the body: whether they bind the intended target, trigger off-targets, or get cleared in minutes rather than hours. “Shape really does…
eConsent as the digital foundation for modern clinical trials
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…
Q&A: Thermo Fisher’s Luke Wilson on hitting 100% dose delivery with patient-centric supply
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…
Lilly launches TuneLab, sharing AI drug-discovery models with biotechs
Eli Lilly launched “TuneLab,” an AI/ML platform that gives selected biotechs access to drug-discovery models trained on years of Lilly research data. Initial public partners include Circle Pharma and insitro. Lilly says the first release reflects more than $1B worth of internal data investment. Lilly says biotechs run its models locally on their own infrastructure…
Real-world data ties COVID-19 to preterm birth risks, spotlights gaps in lung cancer treatment
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;…
Finding signals in the storm: Automation in biomarker discovery
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…
Early-phase study design considerations for long-term follow-up in vaccine clinical trials
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…
Q2 net sales reach $100M for Tarsus’ XDEMVY, with pipeline potential for Lyme rooted in animal health
The one-drug-many-indications model has steadily grown in popularity since the early 2000s. But Irvine, California–headquartered Tarsus Pharmaceuticals is aiming to bring the model to XDEMVY (lotilaner), an antiparasitic drug that first won FDA-approval in dogs. After licensing lotilaner from Elanco, Tarsus won FDA approval for the drug, under the trade name XDEMVY, for the treatment…
This pill makes blood deadly to mosquitoes and reduced malaria by 26%
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…
Sai Life Sciences exec: GLP-1 boom has ‘exploded the peptide field’ as firm opens new center
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 approves first malaria treatment for infants
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…























