The latest crop of glucagon-like peptide-1 (GLP-1) agonists, such as semaglutide and tirzepatide (technically, a dual GIP/GLP-1 receptor agonist), have upended the way we treat metabolic disorders, including obesity. These drugs mimic gut hormones, improving blood sugar control and often leading to significant weight loss. But as Kyasha Sri Ranjan, Ph.D., engagement manager at Lifescience…
GLP-1s overtake metformin in metabolic clinical trials by a wide margin: A visual exploration
A recent review of more than 2,000 studies related at least indirectly to obesity on clinicaltrials.gov highlights the pronounced significant shift in research focus toward GLP-1 receptor agonists for a range of indications with at least some involvement of metabolic disorders. The site, which provides a robust but not-exhaustive snapshot of clinical trial activity, cites…
Unlearn CEO: Digital twins could slash clinical trial patient enrollment by 25% or more
The startup Unlearn embodies several trendy AI characteristics. Generative AI company? Check. San Francisco headquarters? Check. Aims to disrupt drug development (specifically, clinical trials) with AI? Check. Prominent AI leadership? Check. Mira Murati, the high-profile CTO of OpenAI, joined Unlearn’s board of directors in 2023. But the company’s pedigree is unique. The firm was founded…
Iambic Therapeutics and NVIDIA partner to slash cancer drug development timelines
Using generative AI in drug discovery, Iambic Therapeutics (formerly Entos) has advanced its IAM1363 drug candidate from program launch to clinical studies in fewer than 24 months — a process that often takes several years. Iambic Therapeutics’ AI drug development milestone relied on an alliance with NVIDIA researchers and engineers and through the use of…
Q&A: How Insilico Medicine’s AI identified a new IPF drug target in record time
Idiopathic Pulmonary Fibrosis (IPF), a devastating lung disease affecting millions with increasing incidence, may have a new treatment hope thanks to a novel inhibitor of TNIK, a kinase newly implicated in fibrosis, identified using generative AI drug discovery platforms in just 18 months. Researchers at Insilico Medicine, along with international collaborators, harnessed the power of…
FDA fast-tracks psilocybin-based CYB003 for depression
The FDA continues to signal openness to psychedelic-based therapies. Following its recent Breakthrough Therapy Designation (BTD) for a potential LSD-based anxiety treatment, the agency has extended the same status to Cybin Inc.‘s CYB003 for major depressive disorder (MDD). The move marks the first FDA Breakthrough Therapy Designation for an adjunctive, psychedelic-based Major Depressive Disorder treatment.…
Top pharma companies ranked by 2023 R&D spend
Which major pharmaceutical company leads the way in research and development? Data reveals that the top R&D spender in 2023 was Merck & Co., by a wide margin. While Pfizer had almost as much revenue as Merck ($60.1 billion vs. $58.5 billion), its R&D ratio was on the lower end at 18.29%, or $10.7 billion.…
Debiopharm’s multilink technology and partnerships drive oncology pipeline strategy
Debiopharm, an independent Swiss biopharmaceutical company based in Lausanne, seeks to carve a niche in the competitive oncology and infectious disease markets. Its business model focuses on in-licensing promising drug candidates from universities and smaller biotechs, aiming to add value through development. (The company is also partnering with AI-focused firms like VeriSIM Life.) Sandra von…
Biotech layoffs in 2024: Identifying common threads among affected companies
Companies across the industry have contributed to biotech layoffs in early 2024, driven by factors ranging from operational restructuring to strategic pivots and clinical trial failures, with major hubs like California and Massachusetts bearing the brunt of the impact. A recent analysis assembled with the help a machine learning technique known as clustering reveals a pattern of job…
Moving the needle on diversity in clinical trials: Where do we go from here?
Enhancing patient diversity in clinical trials has become a key priority in drug development. The main concern is that critical data that includes underrepresented patient populations is being left out as many clinical trials do not reflect all populations that may eventually take a therapy. These underrepresented groups consist of women, including those who are…
From gatekeeper to strategist: The evolution of the CISO role in drug development
There’s an old joke about chief information security officers (CISOs) being gatekeepers of new technologies and initiatives – the infamous “Department of No.” Imagine a bouncer who, strangely, doesn’t let anyone in, saying the club is already too full, even when it’s clearly empty. But that image is outdated — especially in risk-focused industries like…
Gain Therapeutics’ supercomputer-driven therapy offers potential Parkinson’s breakthrough
The Bethesda biotech Gain Therapeutics, armed with supercomputer firepower, aims to disrupt Parkinson’s disease treatment. Their GCase regulator, named GT-02287, completely restored motor function in a recent animal study. GCase, short for glucocerebrosidase, targets both lysosomal and mitochondrial dysfunction. In Parkinson’s, the failure of cellular powerhouses (mitochondria) and recycling centers (lysosomes) disrupts essential functions. This…
Beyond diabetes and obesity: Can GLP-1 therapies also transform chronic disease treatment?
Glucagon-like peptide-1 (GLP-1) receptor agonists like semaglutide and tirzepatide have cemented their status as two of the most successful drugs in recent memory. Recent projections have estimated that the drug class could fetch $44 billion by 2030 and $71 billion by 2032. But GLP-1 sales could potentially reach greater heights as these therapies move beyond…
Unifying disparate data in clinical trial management with advanced data technology
The increasing complexities in clinical trials, including expanded patient populations, decentralized trials and new technologies, are directly impacting the amount of data and information available to clinical trial sponsors. Though this provides significant value to the industry, it presents a new challenge of consolidating disparate and siloed systems, improving standardization and unifying the explosion of…
Off with the training wheels: AI-based patient characterization can improve clinical trial performance without large data sets
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…
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…
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…