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…
Human study tracks brain’s glymphatic flow in real time, opening Alzheimer’s drug avenues
Applied Cognition, a clinical-stage platform therapeutic company, and academic partners have published the first continuous, non-invasive measurements of the human glymphatic system in Nature Biomedical Engineering. The glymphatic system is a brain-wide waste-clearance network that removes toxic proteins including amyloid-β and tau during sleep. Dysfunction of the system is implicated in Alzheimer’s disease and other neurodegenerative…
Xaira and Verily co-founder ponders low-hanging fruit and blue-sky potential in FDA’s genAI rollout
The FDA is betting big on genAI to transform tedious workflows, setting a June 30 deadline for agency-wide deployment. While details of its plans are scarce at present, using genAI to reduce FDA’s paperwork burden seems inevitable. The broader goal doesn’t qualify as “a high-order AI problem today,” said Vik Bajaj, founder and CEO of…
Sanofi opens $130M corporate hub in New Jersey as part of $20B U.S. investment push
Sanofi has officially opened its new $130 million flagship corporate offices in Morristown, New Jersey. The move consolidates nearly 2,000 employees in a 260,000-square-foot facility designed to accelerate the company’s commercial operations and strategic decision-making in its largest market. The facility replaces Sanofi’s older Bridgewater operations about 19 miles away. The opening of the new…
GSK’s Nucala wins U.S. nod as first IL-5 biologic for COPD
The FDA on May 22 cleared GSK’s interleukin-5 antibody Nucala (mepolizumab) as an add-on to inhaled triple therapy for adults whose chronic obstructive pulmonary disease keeps flaring despite treatment and whose blood-eosinophil count starts at 150 cells/µL. The approval is on the basis of the MATINEE and METREX phase 3 trials. The MATINEE study, which…
Capgemini’s life-sciences lead says ROI and data security, not algorithms, will decide pharma’s AI future
Pharma executives, observing peers in retail and banking tout GenAI payoffs “in weeks and months,” increasingly ask why their own firms can’t match that pace. This pressure for a ROI for an industry that has seen productivity gradually stall since the 1950s. So, when pharma executives ask Sheetal Chawla, Capgemini’s head of life sciences: “When…
As FDA pushes agency-wide generative AI, pharma experience show similar tools can cut clinical study-report drafting time by 30% or more
Jinzhong (Jin) Liu, a deputy director within FDA’s Center for Drug Evaluation and Research (CDER), recently had a “game-changer” experience. New generative AI tools enabled him to “perform scientific review tasks in minutes that used to take three days,” he quipped in an announcement. This success wasn’t isolated; FDA Commissioner Martin A. Makary, “blown away”…
FDA COVID booster pullback jolts vaccine stocks before gains cool
The FDA is scaling back COVID-19 booster approvals to high-risk groups. New rules demand randomized trials for healthy under-65s while preserving annual shots for seniors and people with chronic conditions. Dr. Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), and FDA Commissioner Dr. Martin A. Makary, called for a more evidenced-based…
Austrian researchers find IgA-tagged vesicles turn gut’s own antibodies against it, worsening ulcerative colitis
Understanding the foundations of ulcerative colitis, a condition affection millions worldwide, has proven elusive. Now, researchers at the Medical University of Graz and the University of Graz have shed light on the role of gut bacteria and their antibody-coated vesicles (extracellular sacs) in spiking the chronic inflammation in the colon linked to the condition. Analyzing…
How Thermo Fisher’s KingFisher PlasmidPro crunches hours of plasmid prep to 5 minutes hands-on
Five minutes of hands-on bench time now separates researchers from purified plasmid DNA using a new automated system from Thermo Fisher Scientific. The company’s cartridge-based KingFisher PlasmidPro automates the traditionally hours-long maxi-prep process. The KingFisher PlasmidPro benchtop instrument offers walk-away operation. Kevin Lowitz, vice president and general manager for sample prep at Thermo Fisher Scientific,…
Trump slams ‘global free ride’ on drug pricing in executive order, orders match to lowest global prices
Branding U.S. drug pricing an “egregious imbalance” in which a nation with “less than five percent of the world’s population … funds around three‑quarters of global pharmaceutical profits,” President Donald Trump on 12 May signed the Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients order. The executive order describes the current dynamic as one in…
Intrepid Labs raises $7 million to expand AI-driven formulation platform
Toronto-based Intrepid Labs, which we profiled a year ago, has closed an Avant Bio-backed $7 million seed round, bringing its total financing to over $11 million. The company’s Valiant platform is an autonomous lab technology that pairs machine-learning algorithms with robotics to potentially explore up to 1 billion possible formulations. It aims to cut drug-product design…
FDA’s genAI push could save CDER hundreds of thousands of review hours annually
Determined to slash bureaucratic drag on drug approvals, FDA chief Dr. Martin Makary is ordering every center to plug generative-AI tools into its review pipeline by June 30, an agency-wide gamble that, he says, will turn days of paperwork into minutes of analysis. Multiple independent studies, including from McKinsey, Bain, Capgemini, the Federal Bar Association,…
AI agents could shoulder 55% of biopharma work, Accenture/Wharton study finds
Are AI agents more substance or hype in biopharma? A new report from Accenture and Wharton suggests they are the real deal in biopharma. The two organizations found AI agents, essentially software and physical bots working with minimal oversight, can impact approximately 55% of total workforce hours within a typical biopharma firm. By mapping 300…
Elsevier plugs 500,000 ClinicalTrials.gov records into Embase
Elsevier has pushed roughly half a million ClinicalTrials.gov entries into Embase, its subscription biomedical database. The May 6 update lets R&D teams run a single search that pulls trial data from 200‑plus countries and matches it with Embase’s peer‑reviewed papers, in‑press manuscripts and conference abstracts. Elsevier notes that traditional approaches to synthesizing data from multiple sources…
Can space help heal hearts? ISS study charts new path for stem cell therapy
Emory University stem-cell biologist Chunhui Xu is looking to space for a new way to mend damaged hearts on Earth. Her team is using the International Space Station (ISS) National Lab to test if the near-weightless environment of microgravity can make heart cells divide faster and survive longer, a novel approach borrowed from cancer researchers…
From 1.5% to 5.9%: Deloitte digs into what’s fueling Big Pharma’s R&D IRR climb
Pharma’s long winter of diminishing R&D returns may be thawing. Despite decades of increased spending yielding less bang for the buck, the industry is regaining ground. Deloitte’s closely watched annual analysis charted the slide, with average forecast IRR falling from just over 10% in Deloitte’s inaugural 2010 analysis to a trough of just 1.5% by 2019, a…
Thermo Fisher’s Jane Li on syncing drugs and diagnostics for precision oncology
Precision medicine promises the “right drug, right patient” mantra. One piece that sometimes goes missing? A test approved on day one. Jane Li has spent two decades making sure that gap closes on schedule. As senior director of pharma CDx and CRO partnerships at Thermo Fisher Scientific, she has an important role in this complex…