Drug Discovery and 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…

New CMC Process R&D center will add peptide and oligo-intermediate capabilities, expand analytical and formulation labs and target completion by September 2026. Sai Life Sciences plans to build a 100,000-sq-ft CMC Process R&D center at its integrated R&D campus in Hyderabad, aiming to double its process R&D capacity by September 2026. The project adds dedicated…

In drug discovery, the difference between a breakthrough and a breakdown can be as small as the twist of a bond. Stereochemistry, the three-dimensional arrangement of atoms, governs how otherwise identical molecules behave in the body: whether they bind the intended target, trigger off-targets, or get cleared in minutes rather than hours. “Shape really does…

Pfizer reached a voluntary agreement with the Trump administration on September 30, 2025, to cut prescription drug costs for American patients by matching prices in other developed countries and offering discounts up to 85% via a forthcoming federal platform, TrumpRx.gov, while committing $70 billion to U.S.-based R&D and manufacturing in exchange for a three-year tariff…

Pharma plants are awash in data. There are myriad sources: MES for execution status, LIMS (QC results), process historians (equipment conditions), QMS (quality/deviations) to name just a few, but release decisions still stall when those sources disagree or lack an owner. To deal with the chaos, eschbach’s visual factory centers daily work on SQDCP boards…

AUTOMA+ 2025 is the fifth edition of the Pharmaceutical Automation and Digitalisation Congress, a closed-door, pre-registered meeting expected to draw 300+ participants in Vösendorf, Austria (Nov. 24–25). The 2025 program focuses on implementations in automation, data integrity/validation (CSA/CSV), AI in operations, and integration across MES/LIMS/ERP/QMS. Launched virtually in 2021 and convened in Zurich in 2024,…

In the dynamic world of facility planning and expansion, the initial pre-stages are critical to a project’s success. In advance of diving into feasibility studies, project teams aim to engage in thorough pre-planning discussions to establish clear goals, address logistical challenges, and align design requirements with business needs. Pre-planning is crucial for the success of…

Modern medicine and vaccines have saved millions of lives, but this comes with an environmental cost. A 2019 report by Health Care Without Harm found that the broader health care sector contributes 4.4% of the global total net emissions. This is equivalent to two gigatons of carbon dioxide, the annual greenhouse gas (GHG) emissions from…

The one-drug-many-indications model has steadily grown in popularity since the early 2000s. But Irvine, California–headquartered Tarsus Pharmaceuticals is aiming to bring the model to XDEMVY (lotilaner), an antiparasitic drug that first won FDA-approval in dogs. After licensing lotilaner from Elanco, Tarsus won FDA approval for the drug, under the trade name XDEMVY, for the treatment…

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…

A new foundation model called GREmLN from a Columbia and Chan Zuckerberg Biohub team, delivers superior cell-type classification with only 10.3 million parameters, outpacing rivals like the 100-million-parameter scFoundation. Released July 9 on bioRxiv, it taps gene regulatory networks to achieve a 0.929 macro F1 score on immune cell data. “Instead of using large language…

Let’s say there’s a Black female patient with an aggressive form of breast cancer. She meets with her oncologist to discuss a promising targeted therapy that recently won FDA approval. The drug showed strong efficacy in clinical trials, with a 65% response rate. Yet when she asks about efficacy data specific to Black women, she…

Press release: Southampton, PA – NewAge Industries, Inc., parent company of AdvantaPure™ and NewAge Performance Products, a global leader in fluid transfer systems solutions for the biopharma and industrial markets, is pleased to announce the appointment of Mary Marcus to the position of CEO. “Since her arrival in 2008, Mary has been a vital part…

In 2025, genetic validation is poised to emerge as a high-stakes litmus test in cardiovascular R&D, investors will continue to get better at funneling cash into proven science, and patients will continue their evolution to become more-active partners shaping their healthcare. To hear more about each of these trends, we considered feedback from three industry…

Randomized controlled trials (RCTs) are the gold standard design for studies supporting drug approvals, but they are not always feasible, due to factors such as ethical concerns or very small patient populations.  When an RCT is not possible, researchers may opt for a single-arm trial (SAT), which does not include an internal control group, but…

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…

Xaira Therapeutics, an AI-driven biotechnology startup that emerged earlier this year with a $1 billion funding round, continues to demonstrate its ambitions and staying power. Despite recent biotech industry turbulence, with some AI-focused biotech firms announcing layoffs and restructuring, Xaira has doubled down on growth. The firm is bolstering its leadership roster while announcing a…

Beckman Coulter Life Sciences has announced a new automated clone screening platform for biologic drug development. The Cydem VT system integrates several established technologies — microbioreactor arrays, liquid handling, and analytical measurements — into a single platform capable of monitoring up to 96 parallel bioreactors. The system provides continuous monitoring of pH, dissolved oxygen, and…

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…

Almirall’s MES/MOM director Francesc Luque is spearheading a digital transformation of the company’s pharmaceutical manufacturing, shifting from paper-based and disconnected systems to a fully integrated, “smart plant” model. In a role he assumed in early 2023, the main shift has been consolidating the company’s “Integrated Factory” program and finalizing the definition of its Manufacturing Execution…

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…

Generative artificial intelligence (GAI) has captivated the world, and for good reason. Platforms like ChatGPT have demonstrated capabilities that gave the general public a deeper understanding of AI’s capabilities. AI, too, is showing potential in drug discovery. From designing novel drug molecules to predicting protein structures, AI is offering a new path forward, potentially accelerating…

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…

In some ways, machine learning is nothing new. The term itself dates back to 1958 when the computer scientist Arthur Lee Samuel coined it. “The pharmaceutical industry has been using data science, machine learning, and AI in some form for at least 25 years, if not longer,” said Kailash Swarna, a managing director and Accenture…

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…