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…

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…

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…

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…

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…

At next week’s National Biotechnology Conference, Berlin-based clinical research firm CheckImmune GmbH will showcase how layering single-cell multi-omics provides insights into drug action and immune responses that bulk readouts (averaged measurements from a large population of cells) often miss. In rapid-fire talks on May 6, the Berlin startup will show how single-cell multiomics and spatial…

An MIT research group has unveiled a set of synthetic gene circuits designed to give scientists more  control over gene-therapy treatments, according to a recent paper. The study, appearing in the journal Cell Systems, describes genetic constructs meant to fine-tune how and when therapeutic genes are switched on inside a patient’s cells, aiming to keep…

The clinical-trial intelligence company Lokavant has debuted Spectrum, an AI-powered tool that crunches weeks of feasibility work down to minutes. Pfizer, an early adopter, now refreshes enrollment and timeline projections almost in real time. “Instead of it being five weeks to five minutes, essentially it’s a simulation every five minutes,” said Jonathan Crowther, Pfizer’s head…

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…

In an industry where each lost day can drain roughly $40,000 in direct clinical-trial costs, Lokavant says its newly launched Spectrum v15 can crunch data from 500,000 past studies and deliver enrollment forecasts in five minutes, work that typically takes study teams five weeks. The company claims that the platform boasts 80+% confidence. The company,…

On the surface, President Donald Trump’s latest drug‑pricing order looks like a populist coup. The White House says it will “put American patients first once again,” capping insulin at three cents and promising deeper Medicare savings. Yet nested in the fine print is a directive for HHS to work with Congress to delay Medicare’s power…

With the $30B Keytruda franchise leading, Oncology maintained its top position among the top 50 drugs in FY2024, but significant shifts occurred across therapeutic areas. Metabolic Diseases saw major growth, as GLP-1 agonists like Ozempic (+26%), Mounjaro (+124%), and Wegovy (+86%) reshaped the diabetes and obesity markets. Landmark trials from late 2023 to present also…

A novel gene editing tool named STITCHR, developed at Mass General Brigham and collaborating institutions, overcomes central limitations of current technologies by enabling the scarless insertion of entire genes or large DNA fragments up to 12.7 kb. Based on reprogrammed retrotransposon activity guided by a Cas9 nickase and using RNA templates, STITCHR shows potential for…

Sydney-based Recce Pharmaceuticals has secured A$5.0 million via private placement and launched a A$10.8 million entitlement offer to support Phase 3 trials of its synthetic anti-infectives for diabetic foot infections (DFI) and acute bacterial skin and skin structure infections (ABSSSI). In an April 10 announcement, the company said the combined A$15.8 million raise (before costs)…

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…

Merck & Co. has secured the top spot for pharmaceutical R&D investment again in 2024 after topping the list last year by a wide margin.  While continuing to channel resources into expanding Keytruda’s oncology indications (with a 2025 patent cliff looming), Merck is also expanding beyond oncology. In cardiovascular, it launched Winrevair for pulmonary arterial…

In 2024, Merck’s Keytruda continued its reign with nearly $29.5 billion in sales, posting solid 17.9% growth over 2023. However, the pharmaceutical landscape is shifting rapidly. The combined forces of GLP-1 receptor agonists used for diabetes and weight loss are mounting a serious challenge; Novo Nordisk’s Ozempic surged 25.8% to $17.5 billion, its sibling Wegovy…

Bo Wang, Ph.D., is a Xairanaut. That is, he’s the latest high-profile scientific leader to join the unicorn Xaira Therapeutics, taking the helm as SVP and Head of Biomedical AI. Wang has experience as Assistant Professor in the Departments of Computer Science and Laboratory Medicine & Pathobiology at the University of Toronto, Temerty Professor in…

A recent study published this week, on April 1, 2025, found that pregnant women with SARS-CoV-2 infection may have a lower risk of developing long COVID compared to non-pregnant women. This finding, detailed in Nature Communications, shed light on pregnancy’s protective effects. The large-scale retrospective study, conducted under the guidance of researchers from Weill Cornell…