Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Research into Cold Cancers Heating Up

Activation and expansion are essential for success in both autologous and allogeneic therapies.

Development of Gamma-Delta T-Cell Therapies

Continuous manufacturing and a quality-by-design development approach are a natural fit.

QbD for Small-Molecule Continuous Process Development

Topic

Founder, Kolter AI | Managing Partner, Kamet Consulting Group | Pharma & medtech M&A integrations, divestitures, tech transfers & CMC changes | Ex-PwC

Videos

Megha Sinha, Kolter AI, talks on how orchestrator roles surged in pharma AI, but teams need computed plans, not titles, to close the skills gap.

Midyear 2026 Check-In: Megha Sinha on Pharma's AI Skills Gap

Articles

Novo Nordisk’s complaint contends that Lilly's campaigns leave out information about the most effective injectable doses of Wegovy (semaglutide) and Ozempic (semaglutide) currently on the market.

Novo Nordisk Sues Eli Lilly Over Zepbound and Mounjaro Ads, Alleging Omitted GLP-1 Dosing Data

BMS is scaling AI drug discovery with new NVIDIA infrastructure, cutting research timelines via faster, more efficient computing power.

Everything to Know about BMS & NVidia’s AI Supercomputer

Megha Sinha, Kolter AI, discusses how digital twins run pharma supply chains but  miss the regulatory execution needed to launch changes across markets.

Midyear 2026 Check-In: Agentic AI Cuts Deviation Investigations by 50%

Jeffrey C. Mocny, PhD, is vice president of Regulatory Strategy at Abzena.

Anna McMahon is director of Regulatory Affairs at Cellares.

Jeffrey C. Mocny, PhD, of Abzena, and Anna McMahon, MS, of Cellares, discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.

Using Risk-Based Quality Frameworks to Fast-Track Biopharma Development: A Q&A with Abzena’s Jeffrey C. Mocny and Cellares’ Anna McMahon

FDA proposes a hub-and-spoke manufacturing registration rule and approves three drugs for multiple myeloma, IgA nephropathy, and bladder cancer.

FDA Activity Round Up – July 2026

EMA and EISMEA have formalized their cooperation through a work program aimed at helping small biopharma and medtech innovators engage with EU regulatory requirements earlier in development, potentially reducing late-stage manufacturing and quality problems for complex modalities.

EMA and EU Innovation Agency Deepen Ties to Speed Up Drug Development

Dostarlimab monotherapy achieves sustained 12-month complete response in dMMR/MSI-H rectal cancer, potentially sparing chemo and surgery.

Can Dostarlimab Replace Surgery for dMMR/MSI-H Rectal Cancer?

FDA approves subcutaneous isatuximab-irfc for multiple myeloma, backed by trial data showing efficacy comparable to IV dosing across three regimens.

The Implications of Isatuximab-irfc’s FDA Approval for Multiple Myeloma

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.