Only 12% of new drug candidates that enter phase 1 clinical development ultimately receive FDA approval. This dismal success rate leaves millions of patients with unmet medical needs and drives up the costs for the small number of drugs that make it to market. More frustratingly, it leaves untold numbers of potentially transformative therapies back-burnered…
BIOiSIM assigns ‘credit scores’ to drug candidates
VeriSIM Life, a San Francisco-based startup, has created BIOiSIM, an AI-powered platform that simulates drug compound behavior in the human body by acting like a virtual laboratory. It assigns each a predictive “credit score” predicting its viability for drug development. “It’s like a FICO score for drug development,” founder and CEO Dr. Jo Varshney said.…
Bridging the gap: How resource sheets translate complex clinical trial data into patient empowerment
As patients take a more active role in managing their health, they can find navigating the complexities of clinical trial results daunting. Having access to clear, accurate information is crucial for informed decision-making. This is where patient-reported data from clinical trials has real value, offering key insights into the real world experiences of participants, both…
GLP-1 drugs could open a new frontier in NASH treatment
This morning, Eli Lilly reported positive phase 2 results for its dual GLP-1 and GIP receptor agonist tirzepatide in patients with nonalcoholic steatohepatitis (NASH). In the SYNERGY-NASH trial, the therapy achieved NASH resolution without worsening fibrosis in 61.3% of patients. That is considerably higher than data for semaglutide. Picturing tirzepatide’s NASH resolution in a phase…
After withdrawal, GSK’s Blenrep shows promise in phase 3 DREAMM-7 study
In November 2022, GSK began the process of withdrawing Blenrep’s U.S. marketing authorization after the phase 3 DREAMM-3 trial failed to show an overall survival benefit compared to standard therapy. But GSK has signaled its hope that the B-cell maturation antigen (BCMA) antibody-drug conjugate could have a new lease on life with new data from…
Fixed-dose macitentan-tadalafil polypill outperforms monotherapies in PAH
Pulmonary arterial hypertension (PAH) is a relatively rare disorder, affecting roughly 15 to 50 people per million within the U.S. and Europe. Treating it with a single therapy can be challenging, and medication adherence often presents a common hurdle for the condition. Combination therapy has thus become a widely used option in the treatment of…
Fauna Bio CEO on tapping extreme mammals for human disease breakthroughs
Could the genetic secrets of “extreme mammals” help unlock treatments for myriad human diseases? The Emeryville, California–based startup Fauna Bio is betting on that premise. One of the animals the firm is studying include the 13-lined ground squirrel, which can double its body weight in fat accumulation in summer before entering hibernation in an obese…
Alliance with Google Cloud the latest to help Atropos Health bridge the evidence gap in medicine
The Stanford spinout Atropos Health, which taps real-world data to analyze patient outcomes, disease trajectories, treatment effectiveness, is joining forces with Google Cloud. The company had already forged an alliance with AWS to offer its real-world evidence offerings on the AWS Marketplace and join the AWS Partner Network. The company’s core aim is to give…
How digital pathology can transform the value of clinical trial information
The field of pathology is gradually going digital, marking a pronounced shift from the traditional use of glass slides, a practice that dates back to the Victorian era. Digital pathology uptake reached an “exponential” pace in the wake of the pandemic, noted Dr. Monika Lamba Saini, pathologist-scientist, director of digital innovation at Q2 Solutions, an…
Inside Amgen’s ATOMIC strategy to use ML to accelerate clinical trials
Amgen has developed a machine learning platform to slash clinical trial times through smarter site selection. Known as ATOMIC, short for Analytical Trial Optimization Module, the system crunches disparate datasets to predict optimal trial locations, expedite enrollment and trial processes. Early results indicate more than a two times increase in enrollment speed at ATOMIC sites.…
Biotech bounces back at JPM 2024 on optimism, breakthroughs and calculated bets, but uncertainties persist
At the dawn of 2024, there’s a sense of renewed optimism in the biotech sector despite recent sector-specific challenges. This week, the JP Morgan Health Care Conference witnessed strong deal-making activity. For instance, Merck agreed to acquire cancer drug developer Harpoon Therapeutics for roughly $680 million, highlighting continued interest in oncology cancer therapies. Meanwhile, Novartis…
Medable: AI-powered platform can halve trial build times
Decentralized clinical trial pioneer Medable unveiled an intelligent automation technology at the JP Morgan Health Care Conference, claiming it can slash standard trial build timelines by at least 50%. This development hinges around electronic clinical outcomes assessment (eCOA) — a common bottleneck in trial startups. “We’ve used AI to essentially take a protocol and translate…
Zai Lab’s unified approach to tackling cancer, autoimmune, and neurological diseases
Zai Lab is a global biopharmaceutical company founded in 2014 and based in China and the U.S.. Led by Chairperson and CEO Dr. Samantha Du, the company now has more than 2,000 employees internationally. Focusing on developing novel therapies for oncology, autoimmune disorders, infectious diseases, and neurological disorders, it has built a broad pipeline of…
Integrated bioanalysis strategies in nonclinical early in-vivo PK studies of siRNAs
In molecular biology, small interfering RNAs (siRNAs) have emerged as pivotal tools for regulating gene expression through RNA interference (RNAi). These double-stranded RNA molecules, consisting of 19-23 base pairs, play a crucial role in research and drug development by inducing the degradation of target mRNA and inhibiting gene expression. This article explores the complex world…
Using AI to unlock new uses for existing cancer medicines
Repurposing is a drug development strategy that has been widely applied in cancer. This strategy, sometimes called label expansion, involves obtaining FDA approval to market a drug for the treatment of new indications, alone or in combination with other drugs. Not only can this approach extend the window of patent protection for a commercialized drug,…
How a J&J exec found her calling in autoantibody drug development
Dr. Katie Abouzahr’s career, which began in the wards of the UK’s National Health Service (NHS) before extending into management consulting, paved the way for her leadership of autoantibody and maternal fetal medicine programs at Johnson & Johnson. “It’s not a typical pharma executive’s straight line path,” she acknowledged. “Careers can often be jungle gyms…
LSD shows promise as standalone anxiety treatment in trial
Phase 2b data from MindMed’s LSD-based therapy adds to the mounting evidence that psychedelic-assisted therapies could treat mental health conditions like anxiety, depression and PTSD. In particular, the study found statistically significant dose-dependent improvements in the Hamilton Anxiety rating scale (HAM-A) at the 100 and 200 μg dose levels in the four-week study. Similarly, recent…
Delix’s psychedelic-inspired DLX-001 appears to pose no safety or hallucinogenic risks in early testing
Biotech startup Delix Therapeutics has unveiled promising interim phase 1 safety data for its lead neuroplasticity drug candidate DLX-001 at a leading neuroscience conference, marking the first clinical validation of its “psychoplastogen” pipeline. In essence, the company is developing psychedelic-inspired therapies that can prompt neuroplasticity without the hallucinogenic, psychotomimetic, or dissociative effects typical with traditional…
Zepbound helps people lose 25% of body weight on average 88 weeks, but weight regain is a concern
Lilly’s hot weight loss drug Zepbound (tirzepatide) may be one of the most effective drug therapies for weight loss. In an open-label 36-week study, participants lost an average of 20.9% of their body weight in 36 weeks. With an average weight of 107.3 kg (236.5 lbs), that equates to about 22.4 kg (49.4 lbs) on average.…
Pfizer hemophilia drug marstacimab accepted for FDA, EU review
U.S. and European regulators have accepted applications for Pfizer’s marstacimab, an investigational treatment for hemophilia A and B. The FDA set a decision date in late 2024 while the EMA set the stage for a possible approval in early 2025. The applications are based on positive data from the phase 3 BASIS trial, presented over…
EDC fading in prominence as AI and cloud gain ground
In a year or two, the clinical trial industry may move beyond electronic data capture (EDC), a technology that has been the cornerstone of clinical data management for decades, projects Raj Indupuri, CEO of eClinical Solutions. Given the potential of electronic medical records (EMR) to feed directly into data infrastructure, the need for EDC may…
AWS-NVIDIA gen-AI alliance epitomizes Big Tech’s growing interest in drug discovery
The allure of healthcare has long captivated Big Tech giants. Over the past fifteen years or so, several prominent companies in the sector have ventured into the life sciences sector with ambitious projects, only to often find themselves retreating. The dynamic appears to be changing, particularly in drug discovery, thanks in part to burgeoning data…
At AWS re:Invent, Pfizer exec frames digital as a core business strategy
In the midst of a global pandemic, Pfizer, under the leadership of its chief digital and technology officer Lidia Fonseca, achieved what was once thought impossible. The company, with the partnership of BioNTech, developed a COVID-19 vaccine in only 269 days, a process that traditionally would have taken 8 to 10 years. While prior research…
Merck, Amgen back Culmination Bio’s quest to transform healthcare data analytics
In the same week that Merck and Amgen revealed expanded alliances with AWS, the bioinformatics startup Culmination Bio revealed that it has received $10 million in funding from the venture arms of those companies, Merck Global Health Innovation Fund and Amgen Ventures. Culmination Bio, a spinoff from Intermountain Health, has developed a vast data lake…
Can AI ‘move fast and cure things’ in healthcare?
The entry of AI into healthcare is starkly different from the accepted adage of “move fast and break things” in consumerism. In episode 1 of AI Meets Life Sci, Kayleen Brown, managing editor at DeviceTalks, and Brian Buntz, pharma and biotech editor, discuss the opportunities, limitations, and direct impact of Ai in healthcare fields including…