News

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

The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.

David Dodd, GeoVax Labs, opines on why vaccine platform diversity is critical in the United States.

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.

Five bio/pharma sector leaders dissect FDA’s CNPV pilot program.

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.

Sapient said the workflow will allow for direct measurement of more than 10,000 protein groups in a single, 5-µm slide.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how CDMOs can best handle regulatory inspections and client expectations.

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

The CNPV demands parallel launch execution, requiring sponsors to pre-submit flawless CMC, align pricing with affordability goals, and use enhanced communication.

The new strategic collaboration seeks to develop up to four first-in-class myeloid cell engagers offering broad and safe treatment for blood and solid cancers.

Industry experts weigh in on the potential impacts of FDA’s CNPV pilot on safety trade-offs, resource strain, and unclear incentives for sponsors.

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.

With artificial intelligence and digital technologies transforming the CDMO space, industry leaders at CPHI Frankfurt shared their successes and identified pitfalls.

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.

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.

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 agreement centers on a worldwide, exclusive license to develop and commercialize enzyme replacement therapies using the proprietary platform technology.