BioPharm Weekly News Roundup—Week of Nov. 17, 2025

Welcome to the BioPharm International® weekly news roundup for the week of Nov. 17, 2025. In this video feature, the editors highlight each week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.

CDC’s vaccine-autism policy shift creates regulatory uncertainty, compromising public trust and the commercial viability of vaccine development as well as biopharma compliance.

GSK’s $50M investment in LTZ’s immune-engager platform will help further development of myeloid cell engagers, providing safe, next-generation immunotherapy for cancer treatment.

Programmable biology leveraging non-canonical amino acids and synthetic genomics in a new Constructive Bio–RxCelerate collaboration is expected accelerate novel biologic drug discovery.

Sapient’s mass spectrometry proteomics platform quantifies more than 10,000 protein groups in formalin-fixed, paraffin-embedded tissue, unlocking functional biology insights for biomarker discovery and drug development.

The first liquid IV infliximab biosimilar (Remsima) gained European Commission approval, cutting preparation time by 51% and achieving significant annual cost savings for hospitals.

FDA’s CNPV program accelerates drug review to two months, requiring parallel execution, flawless pre-submission for chemistry, manufacturing, and controls, and adherence to affordability and onshoring goals.

The ultra-fast CNPV program risks compromising safety and straining FDA resources as it requires flawless CMC and mature sponsor governance for participation success.