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…
Revitalizing the brain’s ‘housekeepers’ to combat Alzheimer’s
A potential new strategy against Alzheimer’s disease is taking shape in the brain’s own defense system. By boosting a specific enzyme in the brain’s immune cells, researchers at Cedars-Sinai have dramatically reduced the hallmark plaques of Alzheimer’s and reversed cognitive decline in mice. The news opens the door to potential cellular therapies for a disease…
AI agents are proliferating in pharma, but taming them may be the next frontier
AI agents have moved from pilots to practice: 14% of large enterprises report partial or full deployments and 23% are piloting, according to the “Rise of agentic AI” report from Capgemini. But as adoption ticks up, trust in fully autonomous agents slid from 43% to 27% over the past year. What does that mix mean…
J&J bets on nipocalimab and oral peptides in immunology
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,…
Eli Lilly acquires Verve Therapeutics in $1.3 billion deal, validating gene editing for heart disease
Eli Lilly and Co. has agreed to buy Verve Therapeutics Inc. for up to $1.3 billion, in a move that bolsters Lilly’s push into gene editing for cardiovascular conditions and signals renewed confidence in the sector. The all-cash tender offer values Verve at $10.50 per share upfront. That’s a 113% premium over the company’s 30-day…
Sai Life Sciences exec: GLP-1 boom has ‘exploded the peptide field’ as firm opens new center
Demand for next-generation GLP-1 drugs is fueling a boom in peptide research, prompting companies like Sai Life Sciences to expand capabilities amid a hot market for obesity and diabetes treatments. “The GLP-1 agonists have exploded the peptide field,” said Maneesh Pingle, Ph.D., executive vice president and head of discovery services at Sai Life Sciences, in…
Columbia-CZ team develops 10.3M parameter model that outperforms 100M parameter rivals on cell type classification
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…
NIH announces end to funding for animal-only studies
The National Institutes of Health announced on Monday that the biomedical agency would no longer award funding to new grant proposals solely relying on animal testing. The policy was unveiled at the FDA & NIH Workshop on Reducing Animal Testing in comments from Dr. Nicole Kleinstreuer, Acting NIH Deputy Director for Program Coordination, Planning and…
Korean team reports all-in-one cancer nanomedicine in pre-clinical studies
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…
Why Regeneron’s Lynozyfic FDA approval validates its extreme R&D thesis
KEY TAKEAWAYS: Regeneron (#20 by revenue in FY2024) became the third company to launch a BCMAxCD3 bispecific for myeloma, following J&J (#3) and Pfizer (#2). Company spends 36.1% of revenue on R&D—highest in pharma—growing at 19.5% annually Patent portfolio shows 652 antibody patents (50.3% of total) with 31 bispecific-specific filings Tarrytown, New York–based Regeneron may…
Why Cybin’s CEO sees RFK Jr. and J&J’s ketamine clinics as keys to clinical psilocybin’s mainstream moment
From the Grateful Dead’s tour bus to the FDA’s approval queue, from “turn on, tune in, drop out” to potentially “take two doses and see me in a year,” this is the improbable journey of psychedelics in 2025. We now live in a world where a ketamine analog marketed by Johnson & Johnson could provide…
OS Therapies announces favorable FDA feedback on external control arm strategy for osteosarcoma drug
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…
Nektar’s Phase 2b atopic dermatitis win triggers 1,746% analyst target surge, but legal tussle with ex-partner Lilly could complicate path forward
Nektar Therapeutics’ (NKTR) stock has skyrocketed 287% over the past five days to $33.20 after its experimental drug rezpegaldesleukin hit all primary endpoints in a Phase 2b atopic dermatitis trial, prompting H.C. Wainwright to raise its price target to $120 from $6.50, a 1,746% increase. This represents one of the largest single-day gains in the…
FDA expands Vizamyl label to include quantification and therapy monitoring, creating new competitive edge
GE HealthCare’s amyloid PET imaging agent Vizamyl (flutemetamol) has won an FDA nod for expanded indications on June 24, 2025. The specific update adds quantification and therapy monitoring capabilities that competing products currently lack, positioning the diagnostic as an enabler for the rapidly growing anti-amyloid therapy market. At present, there are two disease-modifying anti-amyloid therapies…
AbbVie announces head-to-head results challenging migraine treatment status quo
For the more than one billion people worldwide living with migraine, the path to effective prevention can feel like an obstacle course. While some migraine patients struggle to find a formal diagnosis, others must navigate a lengthy trial-and-error process with outdated therapies before they can access treatments that provide real relief. Despite migraine ranking as…
GSK sees latest Nucala approval as the first shot in a long-term war to deconstruct and personalize COPD treatment
Chronic obstructive pulmonary disease, a condition CDC estimates affects about 14.2 million (6.5%) U.S. adults, can be brutal. And for patients with COPD, exacerbations are an acute risk, a sudden flare-up where breathing becomes a potentially life-threatening struggle against inflamed airways. “Anecdotally… if I reflect back on some of my experiences in… emergency medicine departments…
Lilly’s oral GLP-1 achieves up to 1.6% A1C reduction and 16 lb weight loss in late-stage diabetes trial
GLP-1s may be the hottest drug class to emerge in recent memory, but their popularity is limited, in part, by cost, lack of payer coverage and the fact that they are generally injectable. For many patients, the prospect of self-injection presents a significant psychological barrier. Studies show that needle aversion affects a substantial portion of…
Parallel Bio’s $21M in Series A will drive aim to trim $2B and 9 years from drug development timelines
Cambridge-based biotechnology company Parallel Bio has closed a $21 million Series A funding round led by AIX Ventures. The company develops a drug testing platform that uses human organoid technology as an alternative to animal testing. The funding round included new investors Amplo and Salesforce CEO Marc Benioff, along with existing backers Metaplanet, Humba Ventures,…
Inside IQVIA’s quest to build a multi-agent AI ‘dream team’ to transform clinical trials
2025 was predicted to be the “year of the agent,” referring to the AI technology that can perform autonomous tasks on behalf of a user. And the trends are lining up. “I think agents are already here,” said Raja Shankar, IQVIA’s vice president, machine learning. With adoption gaining ground in retail, financial services, customer service,…
Sanders, King target DTC pharma ads but the industry worries more about threats to its $2B R&D model
Since the late 1990s, direct-to-consumer pharma ads have become a pop culture fixture. But the practice is facing fresh threats after Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced sweeping legislation that would ban prescription drug advertising across all platforms: television, radio, print, digital, and social media. The End Prescription Drug Ads Now Act…
Dupixent bests Xolair in first head-to-head respiratory trial: 4 takeaways
On the heels of announcing positive data for Dupixent (dupilumab) in atopic dermatitis patients with darker skin tones, Sanofi and Regeneron have announced that the monoclonal antibody outperformed Xolair (omalizumab) in the phase 4 EVEREST trial. Marking the first head-to-head comparison of biologic respiratory medicines, the study focused on patients with severe chronic rhinosinusitis with…
Recursion-MIT AI screens thousands of molecules before a single FEP run completes
Free-energy perturbation (FEP) has long been pharma’s gold standard for gauging how tightly a small molecule binds its protein target, yet each simulation can take 6 to 24 hours and cost hundreds of dollars. Boltz-2, a new open-source model from MIT and Recursion available on GitHub, delivers FEP-class accuracy in about 18 seconds on a…
Insilico’s AI-designed rentosertib shows promise in first phase 2a trial results
An AI-designed drug, rentosertib, from Insilico Medicine improved lung function by 98.4 mL in a 71-patient idiopathic pulmonary fibrosis study published June 3 in Nature Medicine, marking what may be the first peer-reviewed phase 2a result for a molecule generated, with its target discovered, entirely by generative AI. In an email, Insilico CEO Alex Zhavoronkov,…
Why FDA’s Elsa AI tool was inevitable (and just the beginning)
Every month, thousands of drug-promo packages, ranging from TV spots to banner ads and updated labels, land in the FDA’s queue for 2253 review. The agency tracks “the number of required submissions of promotional communications to FDA on Form 2253 and the total number of submitted materials, as a submission may contain more than one…
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
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…