News

Jon Ellis, CEO, shares his thoughts on Trenchant BioSystems’ new technology, its reception within the cell and gene therapy sector, and the future nature of industry partnerships.

Comparing our survey results with recent headlines uncovered biopharma’s digital transformation paradox: high potential vs. low adoption.

To increase CAR-T patient access, healthcare professionals must standardize high-quality delivery, shift to outpatient settings, and overcome current logistical barriers, industry leaders said at a session during the Cell and Gene Meeting on the Mesa.

In a session at the Cell and Gene Meeting on the Mesa, Prime Medicine CEO Allan Reine discussed how prime editing offers versatile, safe gene correction, but that delivery to target cells remains a major hurdle.

A growing demand for liquid medicines is driven by patient groups' unique needs, improving compliance through flexible and palatable dosing options.

The company is expanding its footprint in Japan and South Korea, deepening regional partnerships and aligning focus on biologics manufacturing.

A panel at the Cell and Gene Meeting on the Mesa discussed how advanced therapy production demands modular platforms, automation, and data governance to drastically improve patient access and affordability.

By licensing Talicia to priority markets, RedHill targets growing antibiotic resistance to the cancer-associated H. pylori bacteria with an FDA-approved, fixed-dose therapy

In this week’s news, industry shifts are marked by new FDA draft guidances, Pfizer’s agreement to MFN pricing, Novartis’ launch of DTP distribution, and AI-driven protein design.

The regulatory progress for AAVantgarde’s AAVB-039 underscores advances in dual-vector gene therapy, as well as scalable manufacturing and efficient rare-disease clinical development.

The study by Integra Therapeutics and partners reveals how AI-engineered proteins could expand gene-editing tools and streamline development of advanced therapies.

Pfizer re-balances weight loss portfolio with Metsera, Bristol Myers Squibb and Roche make breast cancer progress, and Keytruda gets under your skin.

This new draft guidance mandates efficient, long-term CGT postapproval monitoring using real-world evidence, registries, and decentralized models, all critical for biopharma.

On July 31, President Donald Trump said the federal government would “deploy every tool in our arsenal to protect American families from continued abusive drug pricing practices” should companies fail to comply.

This innovative trial guidance accelerates cell and gene therapy development for rare diseases, boosting biopharma efficiency and data maximization.

FDA's Center for Biologics Evaluation and Research has released updated draft recommendations for sponsors of cell therapies, gene therapies, and tissue products.

Novartis expands its immunology pipeline with the Tourmaline acquisition and tests direct-to-patient model to reshape drug manufacturing strategies.

The inaugural BioPharma By the Numbers provides a data-driven look at how automation in bioprocessing is driving efficiency, reducing errors, and addressing capacity challenges.

Formulation and analytics are combining to advance drug development synergistically, with evolving tools and related strategies shaping quality, scalability, and innovation.

This week’s roundup highlights US manufacturing localization via tariffs, Pfizer’s $4.9 billion deal, and new tech in CRISPR, RNA, and continuous processing.

The 100% tariff on imported drugs will pressure biopharma companies to build manufacturing sites in the US or face significant costs.

The new protein-based HDR enhancer aims to improve CRISPR precision for advancing cell and gene therapy development workflows.

Quantoom will leverage its proprietary LNP formulation technology, and MSK will have the option to expand the license agreement if there are future developments in Quantoom’s library.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.

BIO-Europe 2025 in Vienna will gather global biopharma leaders to explore investment, manufacturing, and rare disease innovation.

RION partners with Lonza for CGMP manufacturing of PEP, advancing exosome drug development and scalable biopharma production.

The company’s mission to be “continuously innovative” has resulted in the creation of this novel acronym.

Alvin Jogasuria, ProBio; Matthew Lunning, University of Nebraska Medical Center; and Carl Schoellhammer, DeciBio, go behind the headlines to discuss the need for doing more with less.