Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.
Northway Biotech will develop and scale production of AATec’s ATL-105 for the treatment of non-CF bronchiectasis.
Scientists at MIT and other institutions have discovered compounds that activate a defense pathway inside host cells that could be used as antiviral drugs.
FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.
The consortium will focus on the delivery of a fully automated robotics cell and gene therapy manufacturing platform.
Stoboclo and Osenvelt (both denosumab-bmwo) reference Amgen’s Prolia and Xgeva, respectively.
Increased capacity will help Circio progress development of circVec AAV gene therapy and in-vivo cell therapy, with the company setting a goal of selecting its first therapeutic candidate in 2026.
Biocon said that, according to clinical data, both Vevzuo and Evfraxy demonstrated a safety and efficacy profile comparable to that of the reference product.
As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.
Linvoseltamab-gcpt, marketed as Lynozyfic, is a bispecific antibody designed to facilitate T cell activation and cancer cell killing.
The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.
The new building will create 150 new jobs and expands total production area to nearly 12,000 square meters.
Using its proprietary Optimer delivery vehicle, the company said it uncovered a previously unexploited protein marker expressed on activated hepatic stellate cells.
In contrast to earlier conferences in 2025, experts interviewed as part of the BIO conference in Boston did not come to a consensus about lasting impacts of recent changes in US government policy.
The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.
In this episode of the Ask the Expert video series, Simona Guidi, Associate Director, Cell and Gene Therapies at ProPharma, discusses the options available for controlling adventitious contamination in cell processing and the use of closed processing systems for cell therapy production.
EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.
In preclinical trials in mice, the vaccine delivery system provided protection against malaria that was strong enough to stand up to the efficacy of traditional multi-dose regimens.
A key property included in the acquisition is farabursen, an investigational next-generation oligonucleotide targeting the microRNA miR-17 with preferential kidney exposure, intended to treat people with autosomal dominant polycystic kidney disease.
Amyotrophic lateral sclerosis, or Lou Gehrig’s disease, is the most common form of motor neurone disease (MND), with more than 5000 people in the United States being diagnosed with MND annually.
Matthew Stober and Campbell Bunce of Abzena talk about the CDMO’s role in accelerating the path of newer and more effective modalities to market.
The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).
The department’s newly announced partnerships were part of a weeklong visit that included discussions held at BIO 2025.
Some of the companies that received American samples, FDA said, are partially owned or controlled by the Communist Party in China.
FUJIFILM representatives talked about the rebrand of the company’s life sciences businesses, partnerships with Regeneron and other companies, and the importance of having a presence at conferences like BIO 2025.
Bartłomiej Czubek, director of Business Development at Mabion, discussed what’s working, and the challenges set forth by what isn’t working, in the relationships built within the present biologics CDMO market.
The Purolite AP+50 affinity chromatography resin has a 50-micron bead size that offers dynamic binding capacity of the AP resin platform while providing durability for monoclonal antibody capture.
Korro Bio CEO and president Ram Aiyar, PhD, delves into his company’s partnership with Novo Nordisk as a means of reaching a larger patient population with new ideas and approaches.
With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.
BioPharm International® spoke with Robert Cornog, senior director, Product Development, at Quotient Sciences about how commercial manufacturing and tech transfer impact biopharmaceuticals at the development stage.
