Small molecule drug development has changed substantially
in recent years. With the heightened focus on molecularly
targeted therapies, small molecule active pharmaceutical
ingredients (APIs) and drug products are more complex
and potent than ever, requiring increasingly specialized
manufacturing processes and drug delivery solutions. At
the same time, the competitive demand for rapid entry into
clinical development—combined with accelerated review
pathways—translate into compressed manufacturing and
delivery timelines.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.