Feliza Mirasol

Priority review, RMAT, and breakthrough status were key regulatory actions intensely accelerating advanced next-gen therapy development in 2025.

FDA’s new-indication approval for lisocabtagene maraleucel in marginal zone lymphoma boosts engineered T-cell treatment for relapsed lymphoma.

Under the expanded agreement, the companies are targeting amyloid removal strategies to address unmet needs in rare diseases.

siRNA-based cell reprogramming shows potential to improve metabolic health with durable effects, signaling a notable development for future therapeutic strategies.

Engineered exosomes could reshape therapeutic development by redefining delivery, manufacturing models, and regulatory standards.

FDA outlines reduced primate testing for monoclonal antibodies, signaling a shift toward modern evaluation tools that may influence drug development practices.

The new collaboration will aim to streamline formulation-to-manufacturing workflows and de-risk development.

FDA’s internal findings raise new concerns over pediatric vaccine safety and signal potential regulatory shifts affecting future COVID-19 vaccine development.

How is the biopharma industry solving manufacturing and scale-up bottlenecks for cell and gene therapies? Read on to find out.

The discussion in this Drug Digest video focuses on optimizing biopharmaceutical manufacturing and supply chain efficiency through the mastering of AI capabilities, data integration, and critical validation challenges.

ADC oncology platforms, FDA CNPV rapid review, and significant investment into US biologics manufacturing capacity led this week’s news.

Samsung Life Science Fund’s investment in Phrontline Biopharma highlights growing industry momentum behind dual-payload ADCs.

AstraZeneca’s $2 billion investment in its Maryland facilities will expand domestic biologics and rare disease manufacturing and strengthen US drug supply chains.

Progress in vaccine development is closely tied to advancements in biopharmaceutical technologies, regulatory landscapes, and quality assurance methodologies.

News in the week shows biopharma development being redefined by programmable biology and accelerated FDA review, stressing quality compliance and market efficiency.

Regulators and manufacturers face new uncertainty as shifting CDC vaccine language raises concerns for evidence-based oversight and biopharma compliance.

Microfluidic rapid-testing advances enhance real-time QC, strengthen compliance, and speed contamination detection across modern biomanufacturing.

RxCelerate and Constructive Bio will combine programmable biology with integrated discovery tools to speed engineered biologics for hard-to-treat diseases.

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.

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

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.

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.

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