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News|Videos|November 21, 2025

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

Author(s)Feliza Mirasol

News in the week shows biopharma development being redefined by programmable biology and accelerated FDA review, stressing quality compliance and market efficiency.

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.

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