drug development

Oxford Nanoimaging (ONI) recently launched the Aplo Scope super-resolution microscope that pushes imaging precision to 20 nm. The Aplo Scope integrates lasers, optics, chemistry, and software in a compact footprint, helping researchers capture and analyze molecular interactions at the nanoscale. With its user-friendly design and portability, ONI aims to simplify super-resolution microscopy and potentially reduce…

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…

Building on existing integrations with cloud leaders AWS and Google Cloud and collaborations with Arcadia and TD2, Atropos Health is now partnering with Merck. This new collaboration will tap Atropos Health’s GENEVA OS (Generative Evidence Acceleration Operating System) and related tools with the aim of speeding the generation of real-world evidence. Under the agreement, Merck’s…

The understanding that there is a connection between breath and diseases can date back to over two thousand years ago, when Hippocrates described fetor oris and fetor hepaticus in his report on breath aroma (1). Since then, research into volatile organic compounds (VOCs) exhaled in breath and their involvement in disease physiology has led to…

The U.S. Food and Drug Administration (FDA) recently released a draft guidance titled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” This 40-page document, while not legally binding, offers insights into best practices for common questions received by the Office of Therapeutic Products (OTP). While each question is answered in brief, the…

The global AI drug discovery market, valued around $1 to $1.7 billion in 2023, will be worth a multiple of that by the decade’s end. Analysts project the sector could be worth $9 billion or more. 2024 Nobel Prize in Chemistry Recipients: David Baker Demis Hassabis John Jumper Achievement: Computational protein design and structure prediction…

In 2024, we saw the expanded use of synthetic data and natural language processing transform drug discovery and development. In a batch of predictions published in December of 2023, one expert predicted that synthetic data was set to “take off” in drug research. In 2025, the pendulum could begin swinging back the other way, according…

The digital pathology firm PathAI has released PathExplore Fibrosis, an AI-based tool that analyzes fibrosis and collagen structures from H&E-stained whole-slide tissue images. The software quantifies fibrotic areas and collagen fibers from standard pathology slides, replacing specialized staining techniques and microscopy equipment. The tool processes large datasets of tissue images, designed to work with existing…

Swiss pharma giants Novartis and Roche consistently rank among the top pharma companies in terms of revenue. In 2024, the two companies are also leading in total international patent volume. Meanwhile, smaller firms like Incyte and Vertex Pharma are punching above their weight in market impact. For instance, Incyte, with a market cap of just…

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…

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…

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…

Small-molecule drugs have been a mainstay of medicine for over a century, including many of the most impactful pharmaceuticals in human history, such as aspirin and penicillin. Recently, though, biologics—or large-molecule drugs—have become more popular. In fact, in 2016, eight out of 10 of the best-selling drugs globally were biologics. However, small-molecule drugs are experiencing…

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…

It’s something of a truism that about nine out of ten drug candidates in clinical trials fail to reach the market. While some amount of guess-work is unavoidable in drug development, Dr. Ali Pashazadeh, co-founder and CEO of Treehill Partners sees faulty decision-making and poor communication as chief factors contributing to high failure rate. While…

The FDA’s Center for Drug Evaluation and Research (CDER) recently unveiled the launch of the CDER Center for Clinical Trial Innovation (C3TI), which aims to drive clinical trial innovation. When asked to assess the potential impact of the center, Charles Fisher, founder and CEO of Unlearn, said: “The truth is, I don’t know. I’m sort…

A recent review of financial data from 25 major pharmaceutical companies reveals an inconsistent relationship between R&D spending, revenue, and stock returns. The analysis, which included industry giants such as Merck, Pfizer, Johnson & Johnson, and AbbVie, among others, aimed to uncover potential correlations between these key performance indicators. The companies with the highest highest…

In the rapidly evolving landscape of drug development, real-world evidence (RWE) is making significant strides, finding its way into the early stages of the process. No longer confined to just the peri- and post-approval phases, RWE is now being tapped for external control arms (ECAs), aiding in health technology assessment (HTA), and informing payer discussions.…

Over the past decade, the use of deeper sources of real-world data across all stages of the drug development life cycle has become increasingly important to guide disease understanding, trial designs, clinical guidelines, regulatory submissions and post-market studies. The advent of these deeper sources was prompted by the HITECH Act, which had the effect of…

Digital pathology is disrupting the drug development process, replacing traditional microscopy rooted in Victorian Era approaches with high-resolution images and AI-powered analysis tools. In a recent editorial webinar, industry experts Nathan Buchbinder (chief strategy officer at Proscia), Dr. John Cochran (chief medical officer and chief pathologist at Q² Solutions, an IQVIA subsidiary), and Dr. Monika…

PathAI and Roche Tissue Diagnostics (RTD) have inked an exclusive collaboration to develop AI-enabled companion diagnostics that builds on their initial partnership announced in October 2021. To date, PathAI and Roche have commercially launched four algorithms through the partnership. The new partnership will provide biopharma sponsors with integrated technology for developing companion diagnostics incorporating AI-based…

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…

When reviewing R&D spending trends for 2023, Merck & Co. is a clear outlier given its decision to count its $10.3 billion Prometheus acquisition as an R&D charge. In all, the company committed more than half of its revenue to R&D. But Swiss giants Roche and Novartis remain frontrunners in terms of their pipeline of…

A once-controversial psychedelic substance could potentially be a promising treatment for generalized anxiety disorder (GAD). That’s the view of Dr. Rakesh Jain, a psychiatrist with extensive experience in clinical practice, research, and education, affiliated with Texas Tech University School of Medicine. Jain expressed optimism in LSD-based therapy while acknowledging the challenges inherent in such a…

While annual reports show broadly similar R&D strategies among Merck & Co., Pfizer, Johnson & Johnson and AbbVie, their 2020–2023 financial metrics reveal a concerning trend. Merck & Co. may be the new top dog of Big Pharma, but the firm’s 1.4% revenue growth in 2023 represents a significant slowdown. Pfizer’s 41.7% revenue decline from…