Dana M. Krueger, PhD, is Global Healthcare Sector Leader at Russell Reynolds Associates. She can be reached at [email protected] ...

The 2023 revision of Annex 1 of the European Union’s good manufacturing practice (GMP) guidelines 1 represents a fundamental shift in expectations for sterile manufacturing. Reg ...

Lilly licenses Insilico's AI drug discovery platform in a deal worth up to $2.75B, signaling a shift in how novel ...

Using patent intelligence data from the FounderNest platform, alongside funding, partnership, and deployment signals across ...

The FDA has approved a high-dose regimen of Biogen’s nusinersen (SPINRAZA) for the treatment of spinal muscular atrophy. 1 ...

During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus ...

PhD, is a senior applications scientist at Roquette in the Health and Pharma Solutions Business Unit, specializing in formulation design and excipient innovation. She holds a PhD in polymer chemistry ...

Excipient innovation is part of a broader eco-design strategy that integrates sustainability into every stage of product development. By reducing energy consumption, minimizing waste, and sourcing ...

Under Project Optimus, the FDA now expects oncology sponsors to evaluate multiple clinically relevant doses using the totality of the evidence and to identify the dosage that “m ...

FDA’s Project Optimus shifts oncology dosing from MTD to balancing efficacy and safety via metrics like Net Treatment Benefit to pick doses.

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound (s), including magnetite and hematite, on the surface of representative ...

Scale-up involves increasing pump sizes, reactor volumes, and flow rates—but the process control logic and system ...