Frontier EdgeWednesday, May 6, 2026

FDA Launches Real-Time Clinical Trials as Keytruda Biosimilar Shows Early Promise

Sourced from 6 publications

•The FDA initiated two proof-of-concept real-time clinical trials aimed at shortening the gap between data generation and regulatory action.
•Samsung Bioepis reported positive preliminary Phase 1 results for SB27, a proposed biosimilar to the cancer immunotherapy Keytruda.
•Northern Ireland has made injectable Pembrolizumab available at three health trusts, with Health Minister Mike Nesbitt targeting full regional coverage.
•The FDA also fast-tracked access to an experimental pancreatic cancer drug for eligible patients.
•A Lyme disease vaccine based on completed Phase III trials could be available by 2027, according to researchers.

Sources

New cancer jab available for patients at three health trusts

BBC

Daewoong Completes Enrollment for Bersiporocin IPF Phase 2

Businesskorea

Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed B...

Businesskorea

World's first vaccine for Lyme disease could be available in 2027

Refractor

Rare skin condition patients gain access to new treatment

RTE.ie

FDA announces major steps to implement real-time clinical trials

rdrnews

FDA Fast-Tracks Access to Experimental Pancreatic Drug

mychesco

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Curated from 6 sources. Every summary is reviewed for accuracy, but may still contain errors. We always link to original sources for verification.