Merck announced yesterday that the FDA has approved ENFLONSIA (clesrovimab-cfor), a preventive monoclonal antibody, for the prevention of RSV lower respiratory tract disease in newborns and infants entering their first RSV season.  ENFLONSIA is the only RSV preventative option that is administered with the same 105 mg dose regardless of the patient’s weight. It is…

Oncology tops $84B, Mounjaro surges 124%: Your guide to the 2025 pharma landscape. FY2024 reset the competitive landscape in pharma. While oncology held its top sales standing, the rapid ascent of GLP-1s, market erosion from Humira biosimilars, and the advance of new modalities revised the new biopharma hierarchy. This deep-dive report builds on the Pharma…

Respiratory syncytial virus (RSV) already represents a blockbuster business with Sanofi reporting that Beyfortus (nirsevimab) hit global sales of €1.7 billion (roughly $1.77 billion) in its first full year on the market in 2024. Beyfortus protects infants from lung infections caused by RSV Beyfortus can help prevent a serious lung disease associated with RSV in…

Just over three-quarters, 76%, of patients receiving Sanofi and Regeneron’s Dupixent (dupilumab) achieved at least a 75% improvement in overall disease severity (EASI-75), the primary endpoint of the DISCOVER Phase 4 study.   The study, presented at the Revolutionizing Atopic Dermatitis Conference in Nashville, focused on patients with moderate-to-severe atopic dermatitis with skin of color.  Unmet…

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,…

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 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…

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…

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 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…

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…

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…

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”…

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…

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…

Machine learning (ML) has become a cornerstone of modern drug discovery. Today, many companies are taking ML developments a step further using generative AI (GenAI) to search for molecules under specific constraints, such as solubility and patent status, and to optimize for desired properties like potential therapeutic success. In doing so, GenAI can enhance the efficiency, speed…

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,…

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…

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…

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,…

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…

N-acetyl-L-leucine (NALL), an FDA-approved drug for Niemann-Pick disease Type C from IntraBio may hold promise for Parkinson’s disease (PD). A pre-print manuscript posted on Research Square (currently under review at a Nature Portfolio journal) details the relevant preclinical research of the mode of action. It indicates that NALL directly reduces pathological alpha-synuclein, upregulates protective proteins like…

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…

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…

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…