Oncology

In statistics and machine learning, there’s a tradeoff between precision and recall: tune a system to be more selective and you inevitably miss more true positives. Cancer clinical trials have stumbled into a similar trap. As oncology has shifted from tumor-type-centered studies to gene-directed approaches, eligibility criteria have grown exquisitely precise. Instead of enrolling patients…

The FDA has granted simultaneous approval for HERNEXEOS (zongertinib tablets), developed and commercialized by Boehringer Ingelheim, for the treatment of adult patients with non-small cell lung cancer (NSCLC). The approval covers tumors with HER2 (ERBB2) activating mutations. It also signed off on Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to…

AstraZeneca announced a deal with the U.S. government to lower drug prices for American patients last Friday. According to the press release, AstraZeneca agreed “to a range of measures which will enable American patients to access medicines at prices that are equalized with those available in wealthy countries.” Under the agreement, AstraZeneca will provide Direct-to-Consumer (DTC)…

Are GLP-1s on the verge of becoming pharma’s biggest segment? Yes and no. It depends whether you’re watching products or categories. And in terms of individual drugs, it likely depends on the year. Oncology is still on top for now. On the product level, according to Evaluate’s 2028 projections, Keytruda will maintain its lead at…

The pharmaceutical blockbuster model is wobbling. And no single franchise is safe. While king Keytruda, Merck’s stalwart oncology drug, continues to rule the first half of 2025 with $15.2B in sales (Q1 $7.2B, Q2 $8.0B), its U.S. patent expiry in 2028 the single biggest loss of exclusivity event on the horizon. In the U.S., Medicare…

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…

Researchers at the Korea Research Institute of Standards and Science (KRISS) have created a new nanomaterial that can simultaneously detect and treat cancer using multiple approaches. In laboratory tests with mice, the gold-iron particles enabled real-time tumor imaging while delivering targeted treatment through heat, chemical reactions and immune system activation. Published in the Chemical Engineering…

Genmab, a Danish company focused on developing antibody therapies for patients with cancer, opened a new site in Plainsboro, NJ. The company was awarded $8.4 million in tax credits over seven years by the Murphy Administration to develop the new location.  Expanding presence in NJ “Our extension at the Princeton Forrestal Center will strengthen our…

OS Therapies announced it has received positive written feedback from the U.S. Food and Drug Administration (FDA) following a mid-June Type D meeting. The development supports its plan to use an external control arm to support a Biologics Licensing Application (BLA) for its lead candidate, OST-HER2, a Listeria monocytogenes-based immuno-oncology asset originally developed by Advaxis…

Labcorp says it can now move tumor slides at internet speed instead of parcel speed. The diagnostics giant today rolled out a Leica-scanner–based digital-pathology network across its central labs and paired it with new next-generation-sequencing panels and homologous-recombination-deficiency (HRD) testing, a package the company claims will dramatically accelerate biomarker screening for oncology studies, with the potential to significantly…

AP Biosciences is building the protocol around one key objective: confirm that conditional CD137 agonism, a tumor-restricted T-cell costimulation, can be delivered safely in patients whose HER2-positive solid tumors express the p95HER2 variant, a truncated, drug-resistant form of HER2. To that end, it recently dosed the first patient in the Phase 1/2 trial of its…

Cell therapies hold immense promise but, traditionally, carry a similarly large price tag often linked to complex, manual manufacturing. In its latest move to help make these life-saving  and -enhancing treatments more scalable and potentially accessible, Cellares is partnering with the University of Wisconsin School of Medicine and Public Health to automate the clinical-scale manufacturing…

Targeted Protein Degradation (TPD) has  emerged as a promising modality in drug discovery, hijacking the body’s natural disposal systems to eliminate disease-causing proteins. While bivalent degraders like PROTACs have pioneered the field, demonstrating clinical promise, attention is increasingly turning toward a new upstart — Molecular Glue Degraders (MGDs). These smaller, simpler molecules offer advantages but…

COTA Healthcare recently unveiled what it calls a major breakthrough in real-world oncology data (RWD). At the heart of this achievement is a generative AI (GenAI) platform that the company says makes large-scale curation of cancer data both accurate and profitable, marking a significant shift from previous industry attempts to automate the labor-intensive RWD abstraction…

“The era of ‘what if’ for AI in healthcare is over. Now, it’s all about ‘what is.’ ” So says Blythe Adamson, head of outcomes research and evidence generation at the real-world evidence platform Flatiron Health, a company reimagining cancer care infrastructure. “Post-ChatGPT,” she states, “the skepticism has vanished.” The proof? Flatiron is seeing data…

Immunotherapy resistance in solid tumors remains one of oncology’s most significant therapeutic challenges, with multiple cancer types showing limited response to current approaches. Microsatellite stable colorectal cancer (MSS CRC) exemplifies this challenge, with over 90% of MSS CRC cases failing to respond to checkpoint inhibitor monotherapy, while resistance patterns also emerge in many other immunologically…

Three years after demonstrating the first-ever in vivo use of click chemistry by safely delivering 12 times the standard dose of doxorubicin directly to tumors, Shasqi is again pushing boundaries. Its CAPAC platform, which initially relied on intratumoral injections, now targets CEACAM5, a cell-surface antigen overexpressed in lung, gastric, pancreatic, colorectal, esophageal/HNSCC, and cervical cancers,…

After several muted years, the 2025 J.P. Morgan Healthcare Conference signaled a return to big-ticket deals. J&J’s proposed $14.6 billion acquisition of Intra-Cellular Therapies and GSK’s $1 billion purchase of IDRx catapulted this year’s meeting to the largest M&A showing since at least 2019. But behind those high-profile acquisition announcements, JPM speakers and insiders also…

An analysis of FDA approvals across these five years shows small molecules remain central to modern therapeutics, even as complex biologics—particularly monoclonal antibodies (mAbs), antibody–drug conjugates (ADCs), and next-generation modalities—are on the rise. Steady R&D investment in these advanced approaches reflects growing clinical confidence in targeted therapies that address difficult or rare disease pathways. 1.…

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…

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…

The rationale for targeting CDK2, CDK4 and CDK6 has been solid since the discovery of these kinases almost 40 years ago. They sit at the bottom of the oncogenic signaling funnel, meaning that they are the final recipient and executioners of most of the oncogenic signals driving cancer cell proliferation. Cell surface receptors, like HER2…

Breast cancer is the most common cancer for women in the nation, with over 300,000 new cases expected to be diagnosed this year. While the narrative for breast cancer early detection centers around mammograms, the gold standard for diagnosis, clinicians have tapped into enhancing radiology and X-ray imaging using artificial intelligence (AI). This AI-enhanced approach…

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…

Researchers at the Korea Institute of Science and Technology (KIST) have announced a new discovery in the fight against melanoma. The study, published in the journal Molecular Cancer, reveals a new mechanism behind drug resistance in melanoma and proposes potential strategies to overcome it. Led by Dr. Tackhoon Kim, the research team identified that melanomas…