drug development

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…

The U.S. Senate on Dec. 16 passed the FDA Modernization Act 3.0 (S.355) by unanimous consent, sending legislation to the House that would require the FDA to update its regulations to reflect changes Congress enacted in 2022. The bill instructs HHS, acting through the FDA commissioner, to publish an interim final rule no later than…

Okava Pharmaceuticals, a clinical-stage company developing medicines for cats and dogs, announced a new clinical trial testing a GLP-1 implant for cats on Tuesday. The trial is appropriately named MEOW-1 (ManagEment of Over Weight cats).  OKV-119 is Okava’s long-release GLP-1 implant, designed to slowly release the drug over six months. The implant is from Vivani…

Biomarkers have moved from “nice-to-have” to the backbone of drug development, says Quanterix’s Jorge Marques Signes, who argues they now shape feasibility, timelines and even payer expectations before sponsors commit thousands of patients or years of spend. “Biomarkers are not supplemental anymore,” said Marques Signes, VP of Accelerator & Clinical Services at Quanterix. “They are…

Novo Nordisk’s $5.2 billion acquisition of Akero Therapeutics sits at the center of 2025’s hottest M&A space: MASH/metabolic disease. The deal, announced October 9, represents the largest of three major Fibroblast Growth Factor 21 (FGF21) analog acquisitions in five months. Across the broader landscape, 2025 pharma M&A activity reached approximately $70 billion in upfront consideration…

It turns out that AI really is doing the work. At least a growing chunk of it. Artificial intelligence is spreading through the global workforce like wildfire, dwarfing the adoption pace of the internet, with a new Anthropic report citing Gallup research that 40% of U.S. employees now use AI at work. While the field…

While diagnostic pathologists can review scanned slides remotely with AI assistance and instant global collaboration, much of the clinical trial pathology world still ships physical glass slides between labs, dealing with FedEx delays and proprietary file formats. “For exploratory assays, yes, it’s exploding. Everyone’s enjoying artificial intelligence and machine learning for various aspects, but there’s…

Dr. Katie Abouzahr, Johnson & Johnson’s new head of late-stage immunology development, draws on her NHS clinical roots and 11 years at Boston Consulting Group to tackle drug R&D’s most complex challenges. Having recently stepped into the role about a month ago, she oversees a portfolio that includes the newly FDA-approved nipocalimab for myasthenia gravis,…

Scalability is a common issue facing pharma leaders who have deployed Generative AI (GenAI) applications as a proof of concept (PoC). Many are dazzled by their promise of streamlining staid work processes. Agentic AI and other new GenAI technologies can make PoCs faster and easier to launch, advancing scalability as well as security and 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…