Healio

Data monitoring committee OKs continuation of phase 3 trial for vidofludimus calcium

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. An independent data monitoring committee has ruled that ...

Independent Safety Data Monitoring Committee Recommends Initiation of Cohort 2 at the Increased Dose of 10 mg/kg in Entrada Therapeutics’ ELEVATE-45-201 Study

Participants in Cohort 1 have progressed to the open-label, Phase 2 portion of ELEVATE-45-201 -- -- Company on track to report ELEVATE-45-201 Cohort 1 data in mid-2026 -- BOSTON, June 02, 2026 (GLOBE ...
RAPS

FDA issues new draft guidance on data monitoring committees

The US Food and Drug Administration (FDA) on Monday issued a new draft guidance advising certain product sponsors to establish data monitoring committees (DMCs) to ensure that safety signals are ...
Nature

Data Monitoring Practices in Clinical Trials

Data monitoring practices in clinical trials encompass the systematic oversight of accumulating participant data to safeguard safety, integrity and scientific validity. Core to these practices are ...
RAPS

Q&A on Data Monitoring Committees: EMA Drafts Consultation

The European Medicines Agency (EMA) last week opened a consultation on a new question and answer document on data monitoring committees. The seven questions and answers deal with whether DMC ...
FiercePharma

Doctored data, protest from trial observers: Lawsuit points to alleged misconduct at Amgen-bought biotech

ChemoCentryx, the $3.7 billion biotech bought by Amgen in 2022, allegedly ignored repeated warnings from a data monitoring committee and withheld or manipulated trial results on the firm’s ...
Nasdaq

SELLAS Life Sciences Announces Independent Data Monitoring Committee Periodic Review and Positive Recommendation to Continue Pivotal Phase 3 REGAL Trial of GPS in AML Without ...

NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of ...
National Academies of Sciences%2c Engineering%2c and Medicine

Committee on Data Needs to Monitor Evolution of SARS-CoV-2

The National Academies of Sciences, Engineering, and Medicine will establish an ad hoc committee to lay out a framework to define and describe the data needs for a system to track and correlate viral ...
Business Wire

Sensorion Receives Positive Recommendation from Data Monitoring Committee of SENS-501’s Audiogene Phase 1/2 Clinical Trial

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, ...
MPR

Sanofi Ends Phase 3 MOBILIZE Trial of Riliprubart for CIDP

Sanofi is stopping the phase 3 MOBILIZE clinical trial evaluating riliprubart in adult patients with chronic inflammatory demyelinating polyneuropathy who are refractory to standard therapies.

Entrada Therapeutics, Inc.: Independent Safety Data Monitoring Committee Recommends Initiation of Cohort 2 at the Increased Dose of 10 mg/kg in Entrada Therapeutics' ELEVATE-45 ...

Participants in Cohort 1 have progressed to the open-label, Phase 2 portion of ELEVATE-45-201 -- -- Company on track to report ELEVATE-45-201 Cohort 1 data in mid-2026 -- BOSTON, June 02, 2026 (GLOBE ...