Bioversys’ Important BV100 Phase 2b Trial Gets Wellcome Fund
BV100 will advance to an open-label, randomized Phase 2b trial for carbapenem-resistant Acinetobacter baumannii infections, with 90 evaluable patients...
Medera Presents Promising New Heart Failure Gene Therapy Data
Interim results from Medera’s MUSIC-HFpEF Phase 1/2a study reported no gene therapy–related serious adverse events among 10 treated patients,...
Promising New Data on Wilson Disease from Monopar at AASLD
In the Phase 2 ALXN1840-WD-204 copper balance study in Wilson disease, tiomolybdate choline (ALXN1840) produced a rapid and sustained...
How Big Pharma is Rethinking Regulatory Operations in the Digital Era
At the 2025 Indegene Digital Summit, a high-level panel of regulatory executives from Pfizer, Novartis, and Boehringer Ingelheim gathered...
Pacira Finishes Enrollment for Phase 2 Knee Drug Study
Pacira has completed enrollment in Part A of its Phase 2 ASCEND trial of PCRX-201, a locally administered IL‑1Ra...
Replimune Spotlights Late-Breaking RP1 Data at SITC 2025
The objective response rate was 33.6%, with a median duration of response of 24.8 months, in anti–PD-1–refractory advanced melanoma...
Adarx’s siRNA for CFB Shows Positive Phase 1 Clinical Data
A single subcutaneous 6 mg/kg dose of ADX-038 achieved near-complete alternative pathway inhibition—up to 99.6%—sustained through Day 180 in...
InflaRx Announces Topline Phase 2a Data for INF904 Trial
InflaRx will report topline results on November 10 from a Phase 2a study of INF904, its oral C5a receptor...
IO Biotech Presents Pre-Clinical Cancer Vaccine Data at SITC
Preclinical posters from IO Biotech’s pipeline reported tumor growth inhibition and, in a lung metastasis model, reduced metastatic burden....
Coherus Presents Biomarker Data for anti-CCR8 Antibody CHS-114
CHS-114, a cytolytic anti-CCR8 antibody, reduced intratumoral CCR8+ Tregs by 74% and total FOXP3+ Tregs by 43%, while increasing...