As 2024 drew to a close, the cell and gene therapy sector has witnessed a string of recent approvals and some positive clinical trial data such as Mesoblast’s Ryoncil receiving FDA authorization for pediatric graft-versus-host disease in December, Adaptimmune’s Tecelra gaining approval for synovial sarcoma in August, and the landmark clearance of Casgevy (Exagamglogene Autotemcel)…
Top 25 global leaders in cell and gene therapy patents
The cell and gene therapy (CGT) patent landscape reveals a perhaps surprising leader: the German biopharmaceutical company, Immatics Biotechnologies GmbH. As GlobalData has noted, the firm is one of the top filers of patents for CAR-T cell-based therapies. This contrasts with the broader oncology patent space, where well-known Swiss companies like Novartis and Roche have…
Mary Marcus appointed CEO of NewAge Industries
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…
By 2025, clinical research and patient care converge: Data integration, validation, and evolving markets
A growing chorus of experts agree: 2025 signals a year when AI and its generative variants (genAI) move beyond early experimentation into a period of tangible, large-scale impact — including in the life sciences. While challenges remain as EY recently noted, the future will likely be one where the focus shifts from anticipating breakthrough genAI…
FDA drug approvals holding steady at 44 YTD in 2024
YTD 2024 FDA approvals: By the numbers 44 Novel Drug Approvals As of December 5, 2024, the FDA had approved a total of 44 novel drugs, spanning a diverse array of therapeutic areas and patient populations. These new treatments address both widespread public health concerns, such as cardiovascular disease and COPD, and more narrowly defined…
Biotech in 2025: Precision medicine, smarter investments, and more emphasis on RWD in clinical trials
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…
Genomics in 2025: How $500 whole genome sequencing could democratize genomic data
As we edge closer to 2025, advances in long-read sequencing technologies, increasing biobank participation, and a growing emphasis on pharmacogenomics are all set to transform how we diagnose, treat, and prevent diseases. Below, Neil Ward, VP of Pacific Biosciences (PacBio) EMEA, offers insights on what’s happening now—and what’s next—as genomics and precision medicine finally deliver on their promise…
Xaira Therapeutics bolsters leadership team and relocates headquarters to fuel AI-powered drug discovery
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…
Tirzepatide shows 47% greater weight loss than semaglutide in 72-week phase 3b study
A phase 3b open-label randomized clinical trial (SURMOUNT-5) has shown that tirzepatide leads to greater weight reduction compared to semaglutide in adults with obesity or overweight conditions. The study from Eli Lilly demonstrated a mean weight loss of 20.2% with tirzepatide (Zepbound) versus 13.7% with semaglutide (Wegovy) over a 72-week period. Last year, a pre-print…
From biology-first AI to structured digital twin adoption, 4 shifts coming to biopharma R&D in 2025
In 2023, the composite success rate for clinical development in biopharma hit its highest level since 2018 thanks to the adoption of novel trial designs, predictive biomarkers, and digital methodologies, according to IQVIA. But waning R&D productivity is a significant industry concern. A substantial number of life science executives believe their organizations need to rethink…
Why scientific AI needs clear lines of sight — especially for fields like drug development
Today’s large language models can be as unreliable as they are eloquent. Their tendency to fabricate facts and lose the thread makes them risky tools for scientific research, especially in highly regulated industries like pharmaceuticals and chemistry. They also struggle to provide sources and will fabricate a bogus academic journal without batting an eye. Speaking…
Sanofi commits €1 billion to build new insulin site in Beijing
Sanofi announced its largest-ever investment in China, committing €1 billion ($1.04 billion) to establish a new insulin production facility in the Beijing Economic and Technological Development Zone. This strategic manufacturing expansion represents a calculated response to China’s growing diabetes crisis, with recent data indicating 140 million adults living with diabetes as of 2021. The new…
2024: The year AI drug discovery and protein structure prediction took center stage—2025 set to amplify growth
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…
Drug development in 2025: 5 expert predictions cover synthetic data, hybrid trials and more
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…
PathAI launches AI tool for analyzing fibrosis in cancer tissue samples
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…
Projecting the top 20 Big Pharma firms of FY2024
The pharmaceutical industry’s traditional hierarchy continues to face dynamic shifts among the leaders. While Merck ($63.9B) and Pfizer ($62.5B) hold the top spots, double-digit growth from AstraZeneca (~18%), Eli Lilly (~34%), Novo Nordisk (~26%), and Amgen (~18%) signals an accelerating transformation in the sector’s competitive landscape. The continued strength of the GLP-1 market continues to…
3-year study: Tirzepatide prevents diabetes in almost 99% of prediabetic adults
Although Lilly has shared the topline results of the SURMOUNT-1 trial, now, the full data from the three-year study have been published in the New England Journal of Medicine. The company also recently presented the data at ObesityWeek in San Antonio. The biggest conclusion was that 98.7% (752 of 762) of participants who received tirzepatide…
IQVIA’s AI vision is to cut pharmacovigilance costs by 50% with superhuman accuracy
Pharmaceutical companies could slash their pharmacovigilance costs by half while significantly improving accuracy through generative AI, according to IQVIA’s Global Practice Lead of Pharmacovigilance Technologies, Uwe Trinks. “The idea is: we can save 50% of the cost and get the quality to above 99%,” Trinks said. “That means when we have human verification, we only…
One scientist’s quest to teach machines to see cancer the way doctors do
The conceptual and technological underpinnings of digital pathology have been around for decades, with the virtual microscope emerging in the 1990s. But mainstream adoption remained elusive. For instance, when the digital histopathology service company HistoWiz launched in 2013, its focus was straightforward: provide faster turnaround times than traditional histology labs. Over the years, the company…
Anima Biotech aims to open the ‘black box’ of disease with large-scale cellular experiments
While many AI companies focus on analyzing existing scientific literature, this approach faces a fundamental challenge: the reliability of the source material itself. “Up to 70% of experiments described in publications cannot be replicated,” notes Yochi Slonim, CEO of Anima Biotech. “You do it once and you publish it. You do it again, it doesn’t…
AUTOMA+ 2024 talk preview: How Almirall is deploying smart manufacturing for Pharma 4.0
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…
PD-1 agonists show promise in treating rheumatoid arthritis by restoring immune balance
For millions living with rheumatoid arthritis (RA), the path to effective treatment is often a frustrating cycle of trial and error. Typically beginning with disease-modifying antirheumatic drugs (DMARDs) like methotrexate, the goal is low disease activity. Yet RA’s heterogeneity means many patients cycle through various therapies—biologic DMARDs like anti-TNF agents, JAK inhibitors, IL-6 receptor antagonists,…
Roche, Novartis lead 2024’s top 50 pharma in oncology (YTD)
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…
Can LSD break the 20-year drought in anxiety treatment?
In August 2024, MDMA, which is better known as ecstasy, faced a setback as a potential therapy for PTSD—a complete response letter from the FDA. While its developer, Lykos Therapeutics, plans on launching a new Phase 3 trial with tighter scrutiny, another psychedelic company, MindMed, is readying a pivotal study of LSD for generalized anxiety…
Lilly, Novo Nordisk battle surge in copycat weight-loss drugs amid safety concerns
Protein Data Bank Eli Lilly is suing three medical spas and online vendors for selling products purportedly containing tirzepatide—the active ingredient in its weight-loss drug Zepbound. Similarly, Novo Nordisk has pursued legal action against a string of organizations to protect its semaglutide-based drugs from unauthorized competition and potentially unsafe copycat products. The company has filed…