Development

Biogen reports CHMP support for an enhanced nusinersen regimen, signaling potential shifts in SMA treatment strategies and global regulatory decisions.

Experts at AAPS PharmSci 360 discuss industry-wide transformation from AI implementation and the ripple effect on workforce development.

Government and academic leaders say that to prevent catastrophic loss of expertise and investment, coordinated policy and significant investment in workforce talent are urgently needed in the UK.

Help shape industry insights. Take our survey on the biopharma impacts of the FDA Commissioner’s National Priority Vouchers program.

Webinar Date/Time: Tue, Dec 9, 2025 2:00 PM EST

FDA’s newly introduced review route enables faster clearance of custom genetic and cell treatments, reshaping rare-disease development and manufacturing strategies.

The company demonstrates advances in glioma hydrogel, high-concentration biologics, and nanoencorafenib licensing, impacting drug delivery strategies.

At AAPS PharmSci 360, Kelly Donovan says tailored analytical strategies are necessary for reducing development delay risks.

Webinar Date/Time: Thu, Nov 20, 2025 12:30 PM EST

Financing strategies for new modalities and AI will be central at PharmSci 360, shaping how advanced therapeutics move toward global patient access.

A new Cue Biopharma–ImmunoScape partnership seeks to advance targeted TCR-T expansion for solid tumors, supporting broader access and improved clinical durability.

The second installment of the monthly BioPharma By the Numbers infographic series details the hiring and retention challenges faced by US biopharma.

Codexis and Nitto Denko Avecia aim to advance next-gen siRNA production methods for improving scalability of RNA therapeutics.

In the conclusion of a two-part conversation, Viktoria Enkmann of RNAnalytics says she had a hard time understanding the United States’ mRNA decision in August 2025.

Silvia Scaglione of React4Life explores how organ-on-chip systems, AI, and multi-organ models are revolutionizing preclinical testing and advancing personalized therapeutics.

In the first of two parts, Viktoria Enkmann addresses problems with quality control for personalized medicines in the context of lipid nanoparticles and RNA therapeutics overall.

Enzyme engineering holds promise, but Marina Cañellas of Zymvol Biomodeling says the enzymes themselves need to be improved through increased discovery and investigation to be able to achieve a greater amount of chemical reactions.

Webinar Date/Time: Wed, Nov 19, 2025 11:00 AM EST

Organ-on-chip platforms and AI integration are revolutionizing drug development, personalizing medicine, and advancing pharma research, says React4Life’s Silvia Scaglione.

Novartis’ acquisition accelerates RNA drug innovation, expanding genetic therapy pipelines and reshaping biomanufacturing strategies for neuromuscular disease.

Webinar Date/Time: Tue, Nov 18, 2025 11:00 AM EST

Non-parenteral alternatives for biologics remain a clinical imperative and a formidable challenge.

CHMP’s positive opinion for a subcutaneous form of anifrolumab paves the way for a once-weekly at-home lupus treatment option in Europe.

Michael Ritchie, chief commercial officer at Champions Oncology, explains what makes radiopharmaceuticals unique in the treatment of cancer.