Drug Discovery & Development

Drug Discovery & Development magazine provides valuable insights into the entire spectrum of technologies, tools, and business and regulatory approaches that assist scientists and business leaders in speeding up the process and efficiency of drug research and development. The articles are brief and focused, aimed at delivering useful information for everyday technical and business choices.

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Insilico’s rentosertib clears a phase 2a hurdle

3 weeks ago | drugdiscoverytrends.com | Brian Buntz

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.
Why FDA's Elsa AI tool was inevitable

3 weeks ago | drugdiscoverytrends.com | Brian Buntz

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.
Labcorp ramps up oncology R&D speed with advanced diagnostics and digital pathology

4 weeks ago | drugdiscoverytrends.com | Brian Buntz

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 trim traditional timelines.
Human study tracks brain’s glymphatic flow in real time

1 month ago | drugdiscoverytrends.com | Brian Buntz

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 conditions.
Xaira and Verily co-founder ponders FDA’s genAI rollout

1 month ago | drugdiscoverytrends.com | Brian Buntz

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, managing director at Foresite Capital. Bajaj envisions a low-risk, relatively easy scenario where genAI could find widespread use in “the bulk of paperwork” agency-wide.
Sanofi opens $130M hub in New Jersey as part of $20B U.S. investment push

1 month ago | drugdiscoverytrends.com | Brian Buntz

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.
GSK’s Nucala wins U.S. nod as first IL-5 biologic for COPD

1 month ago | drugdiscoverytrends.com | Brian Buntz

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 included 804 patients, found that Nucala reduced these exacerbations by 21% annually (rate ratio 0.79; 95% CI 0.66–0.94; P = 0.01).
Capgemini exec recommends reframing ROI metrics for pharma’s GenAI efforts

1 month ago | drugdiscoverytrends.com | Brian Buntz

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 . So, when pharma executives ask Sheetal Chawla, Capgemini’s head of life sciences: “When will I be able to show the ROI of these [genAI] investments?” Chawla recommended reframing the question. That is, embrace new metrics and new ways of thinking.
AI-informed workflows can help trim clinical-writing hours by 50% or more

1 month ago | drugdiscoverytrends.com | Brian Buntz

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” by such pilot results, has now mandated an “aggressive timeline” for agency-wide AI adoption by June 30, 2025.
FDA COVID booster pullback drives slight vaccine stock gains

1 month ago | drugdiscoverytrends.com | Brian Buntz

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 approach to COVID vaccination in an editorial in NEJM. In their NEJM editorial, Drs.