oncology

On Monday, Citius Oncology announced the U.S. launch of Lymphir (denileukin diftitox-cxdl), the first FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) since 2018.  Lymphir is an IL-2 receptor-directed fusion protein that kills cancer cells by binding to the IL-2 receptors found on the regulatory T-cells and releasing a toxin that inhibits protein…

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…

COVID-19’s grip may have loosened, but its effects on pregnancies linger in data showing higher preterm birth risks for infected mothers. A new analysis from Panalgo, a Norstella company, presented at ICPE 2025, used linked U.S. claims data to match COVID-positive pregnant women against controls. The data revealed a statistically significant increase in preterm deliveries;…

Bispecific antibodies (BsAbs) are redefining the landscape of therapeutic design, offering dual-target precision that conventional antibodies can’t match. These specially engineered antibodies bind to either two different antigens or two distinct sites on the same antigen. BsAbs form a powerful new class of therapy which has caused excitement among the drug development community due to…

As in previous years, the 2025 ASCO Annual Meeting showcased a strong portfolio of practice-changing data across a wide range of tumor types. Combination therapies remain a central theme, continuing to drive meaningful improvements in clinical outcomes. These benefits are increasingly balanced by evolving strategies for managing adverse events, underscoring the field’s commitment to both…

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…

A new study, published in the Journal of Clinical Investigation, suggests that identifying distinct immune “signatures” in patients may help oncologists predict and prevent adverse events associated with immunotherapy. This observational study, reportedly the largest of its kind, prospectively enrolled 111 patients with solid tumors receiving immune checkpoint inhibitor (ICI) therapy at Johns Hopkins. Researchers…

Immunotherapies, including cellular immunotherapies, have dramatically impacted the treatment of cancer. Recent advances in the field, such as autologous (patient-derived) chimeric antigen receptor (CAR)-T cell therapies, have yielded remarkable results in relatively rare blood-based cancers. These results have driven an explosion in the research and development of different cellular products, including both autologous and allogeneic…

Imagine tripling or quadrupling the speed at which eligible patients are matched to potentially life-saving cancer trials. That’s the promise of ConcertAI’s AI-powered screening technology, which demonstrated a 3 to 4 times efficiency gain over traditional EMR-based methods in a recent study presented at the American Society of Clinical Oncology (ASCO) conference. Focusing on relapsed…

[Updated May 21, 2024.] 2023 may not go down as the brightest year for the pharma sector, but the entry of Novo Nordisk’s Ozempic (semaglutide) into the ranks of top-selling drugs like Keytruda, Dupixent, and Eliquis signals a new era in the treatment of metabolic disease. Novo Nordisk’s sales jumped by more than one-third in…

Which major pharmaceutical company leads the way in research and development? Data reveals that the top R&D spender in 2023 was Merck & Co., by a wide margin. While Pfizer had almost as much revenue as Merck ($60.1 billion vs. $58.5 billion), its R&D ratio was on the lower end at 18.29%, or $10.7 billion.…

The top 20 healthcare-focused biotech companies collectively raised $2.9 billion in the first quarter of 2024, according to data sourced from Crunchbase. That represents a 161% increase compared to the $1.1 billion raised by the 20 largest funding rounds involving healthcare-focused biotech companies in Q1 2023, indicating more confident bets on the market viability of…

Lantern Pharma’s AI-powered sprint  Lantern Pharma (NASDAQ: LTRN), a publicly traded clinical-stage biotech company with a market cap of around $79 million as of mid-March 2024, is shooting for developing $200 million drugs with a machine learning-based platform. The oncology-focused firm Lantern Pharma, profiled last year, has advanced its new drug (LP-284) to a Phase…

Debiopharm, an independent Swiss biopharmaceutical company based in Lausanne, seeks to carve a niche in the competitive oncology and infectious disease markets. Its business model focuses on in-licensing promising drug candidates from universities and smaller biotechs, aiming to add value through development. (The company is also partnering with AI-focused firms like VeriSIM Life.) Sandra von…

In episode 3 of AI Meets Life Sci, DeviceTalks Managing Editor Kayleen Brown and Pharma and Biotech Editor Brian Buntz sit down with GE HealthCare GM of Oncology Ben Newton and Haley Schwartz of Catalyze Healthcare to discuss the impacts of AI to screen, diagnose, prognose, and treat cure disease while addressing real-world implementation issues from regulation and liability to clinician trust and adoption. They review the AI…

At the dawn of 2024, there’s a sense of renewed optimism in the biotech sector despite recent sector-specific challenges. This week, the JP Morgan Health Care Conference witnessed strong deal-making activity. For instance, Merck agreed to acquire cancer drug developer Harpoon Therapeutics for roughly $680 million, highlighting continued interest in oncology cancer therapies. Meanwhile, Novartis…

Oncology may continue be one of the hottest sectors across the pharma sector, but other therapeutic areas are catching up in terms of innovation and investment. While oncology and hematology jointly accounted for about one-third of the new FDA approvals in 2023, investors are increasingly betting on precision medicine, advanced drug delivery systems and the use of…

2023 was a big year for hematology, neurology and oncology, with the medical specialties seeing the most FDA approvals. In terms of sponsors, Pfizer had the most approvals with six total, followed by UCB and Chiesi, each with three apiece. When looking at commercial prospects, AstraZeneca’s respiratory syncytial virus antibody Beyfortus could be the biggest…

Despite challenging interest rates and regulatory environment, pharma M&A activity surged in 2023 with deal volume up more than 30% from the prior year based on a review of more than 200 acquisitions since 2018. The total disclosed deal value in 2023 also more than doubled the prior year’s tally to surpass $100 billion. While…

As the year draws to a close, it is clear that molecular science and diagnostics is the hottest funding area in the biotech industry. In an analysis of 50 of the best-funded biotechs of 2023 focused on human health, molecular and science and diagnostics startups collectively attracting roughly $945 million, dwarfing the figures in other…

A vision for data-driven drug development in oncology When Peter Carr, principal software architect of Lantern Pharma, stepped into his full-time role in September 2020, the company was on the cusp of a transformation. While AI had been a focus for a number of years, a fresh infusion of cash provided a possibility of expanding…

San Francisco-based oncology startup, Shasqi, announced an expansion of its research collaboration with Johnson & Johnson Enterprise Innovation. The partnership centers on Shasqi‘s CAPAC platform, which is an abbreviation for Click-Activated Protodrugs Against Cancer. The platform separates tumor-targeting from the actual drug payload with the aim of maximizing potency while minimizing toxic side effects.  Shasqi’s…

Global pharma and medical device giant Johnson & Johnson (J&J) has ditched its iconic cursive logo that dates back to the late 19th century, and rebranded its Janssen pharma division as Johnson & Johnson Innovative Medicine. The move underscores the company’s push to prioritize higher-margin prescription drugs. This strategic move comes amidst a backdrop of…