Feliza Mirasol

This week’s news highlights biopharma R&D’s focus on new biologics and CGT innovation, with growth fueled by AI adoption and significant investments into market expansion.

ARM board member Miguel Forte highlights education programs, innovation hubs, and hands-on training to foster workforce expertise in the biopharma industry.

Maximizing value in advanced therapies requires the use of proven approaches, expert logistics, and tailored distribution, says Miguel Forte, board member of ARM.

Groundbreaking gene delivery, scalable IPSC approaches, and advanced production solutions will impact future CGT development, according to ARM board member, Miguel Forte.

ARM Board Member Miguel Forte highlights CGT investment shifts, sector resilience, and alternative funding strategies during Meeting on the Mesa.

Cellevate’s nanofiber technology enables higher viral vaccine titers in adherent cell cultures, advancing efficiency in large-scale biomanufacturing.

Scaling biopharma innovation demands advanced manufacturing, global market expansion, and solving patient access barriers.

Industry leaders at Meeting on the Mesa discussed big biopharma’s role in next-step CGT scale, focusing on manufacturing quality and patient access.

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 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.

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.

Naobios and Olon France create custom HCP ELISA to advance vaccine trials and strengthen global biopharmaceutical manufacturing capacity.

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.

This new draft guidance mandates efficient, long-term CGT postapproval monitoring using real-world evidence, registries, and decentralized models, all critical for biopharma.

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

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

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

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.

Pfizer will expand its obesity drug pipeline with Metsera’s clinical incretin and amylin programs, highlighting advances in biopharma development and manufacturing.

New GS knockout CHO-K1 systems accelerate biologics manufacturing by improving yields, scalability, and flexibility for biopharma development programs.

Regulatory crackdowns on risk disclosure rise, policy instability affects public health, and drug innovation focuses on advanced therapies and AI-driven discovery.

ACIP votes to separate MMR and varicella vaccines (MMRV) for children to cut febrile seizure rates.

CPHI Pharma Awards 2025 highlight breakthroughs in bio/pharma technology, sustainable manufacturing, and industry leadership.

The Phase IIa trial will further explore the EP4 antagonist HTL0039732 in combination with immunotherapy to improve outcomes in resistant solid tumors and expand treatment options.

SynaptixBio CEO Dan Williams discusses how small biotechs drive rare disease innovation with genetic research, partnerships, and patient advocacy in a third interview installment.

CSL will fund Phase III clinical development of VMX-C001 with an option to acquire VarmX.