Abstract Despite a wealth of case studies and recent FDA guidance highlighting the advantages of community-level engagement in clinical trials, local clinics and research sites with access, trust, and experience in treating diverse patient populations are frequently overlooked and under-resourced in the drug development process. Lloryn Hubbard and Zoé Felicié, patient diversity experts at the PPD Clinical…
Q&A: Oracle launches new cloud service to analyze global oncology treatment trends
Traditionally, only a small fraction of oncology drugs make it from phase 1 to commercialization. And biopharmaceutical companies continue to face significant challenges in understanding how new oncology drug approvals affect treatment patterns and market share. To deal with such hurdles, Oracle has recently launched CancerMPact Treatment Architecture Trends (PDF overview here), a resource that…
Scorpion’s STX-478 shows promising efficacy and tolerability in early cancer trial
Scorpion Therapeutics’ new oral cancer drug, STX-478, showed promising anti-tumor activity as a monotherapy in a Phase 1/2 trial, achieving an overall response rate (ORR) of 23% in breast cancer and 21% across all tumor types studied. The data were unveiled at the European Society for Medical Oncology (ESMO) Congress 2024, held 13–17 September 2024.…
Kisqali slashes recurrence risk by 28.5% in early breast cancer
Updated results from the Phase 3 NATALEE trial reveal that Kisqali (ribociclib) significantly cut the risk of recurrence in patients with HR+/HER2- early breast cancer. Adding Kisqali to standard endocrine therapy (ET) resulted in a 28.5% reduction in invasive disease-free survival (iDFS) events compared to ET alone (HR=0.715; 95% CI: 0.609–0.840; P<0.0001), Novartis announced in…
Important ERP considerations for biotech manufacturers
Manufacturers in the biotech sector face unique challenges ranging from stringent regulatory requirements to complex production processes. Implementing an ERP (enterprise resource planning) system tailored to their needs is crucial for ensuring compliance, efficiency, and scalability. Whether you are a life sciences CMO (contract manufacturing organization), a pharmaceutical manufacturer with an R&D department, or a…
How Fovus enabled a biotech to accelerate high-throughput screening by up to 96x with cloud HPC
Let’s face it: Cloud-based High-Performance Computing (HPC) offers unprecedented computational power. These systems can perform quadrillions of calculations per second. But that computational horsepower comes at a price – not just financially, but in the form of a steep learning curve and a constant battle against configuration headaches, unpredictable costs, and delays. For researchers working…
From Bayer’s regulatory streamlining to Superluminal’s protein modeling, Google Cloud’s AI gaining biotech momentum
Google Cloud’s Shweta Maniar is on a mission to revamp drug discovery with the power of generative AI, the trendy type of AI that can create new content. The tech is well-suited for a range of applications in drug discovery and across the life sciences. Whether it’s supporting organizations in their drug discovery efforts or…
QuantHealth’s AI simulates 100+ clinical trials with 85% accuracy
QuantHealth, an AI-focused clinical trial design company based out of Tel Aviv, has announced the completion of more than 100 simulated clinical trials, reporting an 85% accuracy rate. The company, which received $17 million in a Series A funding round with backing from Accenture, aims to chip away at the steep costs and stubborn timelines…
Lilly’s tirzepatide cuts diabetes risk by 94% in those facing obesity
Eli Lilly’s hit drug tirzepatide has demonstrated a 94% reduction in the risk of developing type 2 diabetes among overweight and obese prediabetic adults, according to new findings from a 176-week Phase 3 trial. The SURMOUNT-1 study, the longest completed trial of tirzepatide to date, also showed sustained weight loss through the treatment period, with…
See how much Medicare plans to cut drug prices for Eliquis, Jardiance and more
Medicare is taking its scalpel to drug prices, excising billions in costs for popular medications like Eliquis and Jardiance. The Biden-Harris Administration announced significant agreements with drug makers that would cut list prices by up to 79% for the first 10 drugs selected under the new Medicare drug price negotiation program. CMS announced last year…
FDA rejection of MDMA and journal retractions jolt psychedelic therapy research
In a double-blow to psychedelic therapy, the FDA has rejected an application for MDMA-assisted treatment of PTSD, while a prominent medical journal has retracted three key papers on the subject. The agency, which had granted Breakthrough Therapy Designation to MDMA in 2017, signaled it may be open to changing its mind if presented with data…
Liraglutide shows promise in lessening Alzheimer’s symptoms in phase 2b trial
Liraglutide, a GLP-1 receptor agonist medication that first won FDA approval in 2010, may reduce cognitive impairment in Alzheimer’s patients. At this year’s Alzheimer’s Association International Conference, data from a Phase 2b clinical trial with 204 mild AD patients serving as participants was revealed, showing that the drug lowered decline in cognition by up to…
How adaptive trials can enable seamless phase 2b/3 studies
In drug development, time lost is literally money lost and every day of delay can potentially cost millions. People in the industry are exploring new strategies to get drugs to market faster with potentially fewer patients, as Pina D’Angelo, VP of Biometrics at Innovaderm, pointed out. Adaptive clinical trial designs can be a notable tool…
ChatRWD outperforms tech giants in medical question-answering
When it comes to medical AI, the biggest names aren’t necessarily delivering the best results. While tech giants race to build ever-larger language models, a new preprint reveals that when it comes to clinical accuracy and physician trust, a smaller player is outperforming the industry heavyweights. Putting large language model-based systems to the test Researchers…
4 waves of NLP techniques and how to stitch them together
While clinical trials and regulatory filings offer a semi-structured view of drug safety, a large amount of insights lie in sources ranging from patient support programs (PSPs) to social media posts. As Natural Language Processing (NLP) evolves, a growing number of tools are becoming available to unlock this potential. Deepanshu Saini, Director of Program Management…
From social media to safety signals: How AI and NLP are transforming drug safety monitoring
The pandemic, the rise of decentralized trials and a wave of technological advances have each played a role in reshaping clinical trials and safety reporting. While these events have been changing the industry, the internet’s growing convenience and accessibility has also empowered and transformed the patient experience. Patients are increasingly turning to online platforms, particularly…
Phesi’s digital twin study uses 2,000+ patient records to model cGvHD treatment outcomes
Phesi, a Connecticut-based clinical development analytics company, has published research in Bone Marrow Transplantation showing the potential of digital twins to replace standard-of-care control arms in clinical trials. The study focused on chronic graft versus host disease (cGvHD), a serious complication affecting 30–50% of the 50,000 cancer patients who receive hematopoietic cell transplantation (HCT) each…
What if AI makes good on its promise to reshape the pharma productivity?
One of the top promises of artificial intelligence/machine learning in drug discovery is reversing decades of dwindling productivity. But imagine if the technology makes good on its promise. And perhaps six or seven years from now, in which productivity is doubled, leaving pharma firms to have, theoretically, early stage pipelines that are twice as large.…
NVIDIA and Recursion’s candid conversation on AI’s next big leap in drug discovery
NVIDIA was founded in 1993 when Jensen Huang, Chris Malachowsky, and Curtis Priem met at a Denny’s restaurant near San Jose. With just $40,000 in starting capital, they sketched out their vision for the company over diner food. In its early days, the silicon chip industry was laboratory-based, empirical-based. Since then, the industry has shifted…
Boehringer Ingelheim launches phase 1 trial for triple-action obesity drug
Boehringer Ingelheim has partnered with Gubra, a specialized biotech company and preclinical CRO that specializes in peptide-based drug discovery for metabolic diseases, to launch phase 1 clinical trials for BI 3034701. This drug candidate is a long-acting peptide designed to target three different receptors associated with weight loss, offering a potential new avenue for tackling…
6 signs AI momentum in drug discovery is building
As pharma giants like Darmstadt, Germany–based Merck KGaA announce new pacts with AI companies, the drug development landscape is witnessing a familiar pattern of emerging tech adoption. AI’s promise of faster, more efficient drug discovery has captured the industry’s imagination, leading Big Pharma to ramp up investment in AI startups and partnerships. Yet, the technology’s…
Tirzepatide cut sleep apnea index by up to 63% in phase 3 trials
Today, Lilly announced promising data for the SURMOUNT-OSA phase 3 clinical trials testing tirzepatide in adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. The company shared the data at the American Diabetes Association’s (ADA) 84th Scientific Sessions while publishing them in The New England Journal of Medicine (NEJM). The SURMOUNT-OSA phase 3 trial consists…
How BMS aims to close the LGBTQ+ data gap in clinical trials
In terms of treatment outcomes, the LGBTQ+ community continues to face significant disparities. For instance, a recent study in JAMA on breast cancer outcomes reported that those from sexual and gender minority groups were more likely to face delays in diagnosis. LGBTQ+ patients were also more likely to decline oncologist-recommended therapies while experiencing a three-fold…
Why Empress Therapeutics is mining the human metagenome for novel therapies
Empress Therapeutics, which exited stealth mode a year ago, has already discovered 15 drug leads across multiple diseases and target classes. Launched in 2020, the Flagship Pioneering startup is now driving towards filing multiple IND applications within the next 24 months. While AI has played a role in compressing those timelines, the company is focusing…
Iambic and NVIDIA: Using AI to chart a faster course for drug discovery
Featured on the cover of Nature Machine Intelligence, one of Iambic Therapeutics‘ AI platforms, known as NeuralPLexer, can accurately predict protein-ligand complex structures. The platform excels at predicting the complex 3D structures formed when proteins bind with drug-like molecules. In a benchmark study featured in the publication, NeuralPLexer outperformed other systems, including AlphaFold2, in its…