Biopharma News

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

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

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.

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

At AAPS PharmSci 360, Siddhant Sojitra defines a scientifically justified agitation model for the early-stage development of high-concentration biologics.

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

In Episode 28, Miroslav Gasparek, Sensible; Lizzy Lawrence, STAT; and Joe Lewis, Deloitte, go behind the headlines.

As pharmaceutical tariffs reshape costs and global supply chains, it’s essential for industry professionals to be informed about their core impacts and underlying mechanisms.

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

Toni Manzano, PhD, discusses his CPHI Europe presentation, stating that AI is essential for managing complex drug and biologics manufacturing.

Toni Manzano, PhD, Azion, says AI integration in drug manufacturing necessitates regulatory risk assessment, cloud infrastructure for big data, and strict data integrity compliance.

According to a CPHI Frankfurt keynote panel, Europe's biopharma sector must accelerate adaptation to new regulations to stay competitive with the US and China.

Toni Manzano, PhD, Aizon, says AI adoption in biopharma, supported by new GXP guidelines, is challenged by poor data quality and the complexity of industrializing many specific models.

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

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

In episode 27, Christopher Hopkins, PhD; Omkar Kawalekar, PhD; Barnaby Pickering; and Jerry Rosenbaum, MD, go behind the headlines.

The BioPharm International biopharma industry report on digital transformation uncovers an adoption paradox. This video summarizes our findings.

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.

As cell and gene therapy is poised to play a major role in the future of medicine, it’s important to know the basics.

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

Comparing our survey results with recent headlines uncovered biopharma’s digital transformation paradox: high potential vs. low adoption.

By licensing Talicia to priority markets, RedHill targets growing antibiotic resistance to the cancer-associated H. pylori bacteria with an FDA-approved, fixed-dose therapy

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.

Pfizer re-balances weight loss portfolio with Metsera, Bristol Myers Squibb and Roche make breast cancer progress, and Keytruda gets under your skin.

The inaugural BioPharma By the Numbers provides a data-driven look at how automation in bioprocessing is driving efficiency, reducing errors, and addressing capacity challenges.

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.