Feliza Mirasol

The EC approves the world's first liquid IV infliximab biosimilar, which cuts preparation time by 51% and offers up to €2.6 million (US$3.0 million) in potential annual savings.

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

Eric Hill, Chief Scientific Officer, BA Sciences, discusses the how E&L testing principles can be adapted to biologic products and the unique challenges biologic drugs face regarding E&Ls.

This week’s biopharma news highlights formulation stability testing, automation in analytics, and achieving regulatory compliance.

Eric Hill, Chief Scientific Officer, BA Sciences, discusses the analytical challenges involved in conducting E&L testing for biologic drug products.

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

Reliable bioanalysis and regulatory-compliant study design enhance drug development, says Alturas’s Sara Underwood at AAPS PharmSci 360.

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

At AAPS PharmSci 360, Ely Porter, PhD, says automated platforms enhance drug production velocity and assay excellence.

At AAPS PharmSci 360 2025, Siddhant Sojitra, Alexion, defines an agitation model to reliably test stability for early-stage biologics.

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

Novel biologics, from ADCs to in-vivo cell therapy, drive AI-enhanced quality control and supply chain flexibility in global biopharma innovation.

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

AI, gene therapy, top research breakthroughs, and more will be highlighted at this year’s AAPS PharmSci 360, according to programming chair, Mei He.

Shilpa Biologicals CEO Sridevi Khambhampaty addresses funding pressures, regional supply strategies, and expanding ADC development.

Biologics output improves via planning and automation as digitalization predicts batch outcomes, requiring strong data and worker expertise, KBI Biopharma’s Sigma Mostafa explains.

AI and innovative technology platforms are revolutionizing biopharma R&D and manufacturing, but success requires high data quality and next-gen solutions.

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

Digital platforms, automation, and new tech are driving efficiency, innovation, and advanced skill building in biomanufacturing, according to Sigma Mostafa of KBI Biopharma.

Biopharma innovators were recognized at CPHI 2025 for advances in drug delivery, continuous bioprocessing, and supply chain capabilities shaping global therapies.

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

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.

News from the week emphasizes improvement of patient access and supply-chain resilience through AI-driven manufacturing and digital traceability.

Abzena’s antibody platform enables Orion to streamline biologics development, showcasing trends in scalable, risk-reduced manufacturing for the industry.

SK pharmteco expands US peptide production capacity, strengthening domestic API manufacturing and accelerating biopharma process development.

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

A new leadership summit and expert tracks explore AI, sustainability, and next-gen manufacturing shaping the future of global biopharmaceutical development.

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.