In the Spotlight April 2004

Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create.

Roche-Hansoh, Merck KGaA-Silence, and Lilly-METiS deals show how ADCs, siRNA, and lipid nanoparticles reshape demands on CMC and manufacturing teams.

Germany is home to several prominent pharma companies and more than 1000 innovative biotechs.

Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.

The deadline to comment on FDA's generative AI paper is Oct 19, 2026. We explain why professionals in pharma manufacturing should weigh in.

The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.

AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.

Ishani Maharaj of Ingredients + Specialties from Univar Solutions explains how to stabilize GLP-1 multi-agonists, weigh delivery formats, and qualify novel excipients and suppliers.