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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.

Trump’s tax bill could reshape drug R&D, manufacturing, Medicaid access, clinical trials, and biotech funding, impacting strategy across the bio/pharmaceutical industry.

As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.

Once limited to experimental vaccine platforms, messenger RNA (mRNA) is now taking center stage across the entire biotech landscape.

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.

Regulatory shift reflects maturation of CAR-T field and impacts biopharm manufacturing, development, and discovery.

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.

The biotech company urges government action to support newborn genome screening, emphasizing the need for rare disease care, testing, and family resources.

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.

Lilly expands into genetic medicines with Verve's in vivo gene-editing therapies, aiming to replace chronic cardiovascular treatments with single-dose care.

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.