Lipocine Reports Encouraging Progress Post Second Interim Safety Review in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the completion of ...
The New England Journal of Medicine

Don't Mess with the DSMB

If the lyrics of the popular Jim Croce song from the early 1970s were adapted for a clinical trialist anthem, the refrain would likely be You don't tug on Superman's cape You don't spit into the wind ...
News Medical

DSMB recommends continuation of Phase 2/3 study of opaganib for severe COVID-19

RedHill Biopharma Ltd. ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of ...
Yahoo Finance

Medera Receives DSMB Clearance to Initiate Phase 2 Portion of MUSIC-HFrEF Phase 1b/2 Trial for SRD-001 Gene Therapy in Heart Failure with Reduced Ejection Fraction

BOSTON, March 20, 2025 (GLOBE NEWSWIRE) -- Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on cardiovascular diseases with high unmet need by developing a range of ...
Business Wire

Annovis Bio Receives Positive Recommendation to Continue Phase 2/3 Trial of Buntanetap for Alzheimer’s Disease Patients From the Independent Data and Safety Monitoring Board ...

BERWYN, Pa.--(BUSINESS WIRE)--Annovis Bio, Inc. (NYSE: ANVS), announces the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase 2/3 trial of buntanetap, a drug ...
CNN

The secretive group at the center of the nation’s largest vaccine trials

Still, downstream from the DSMB, Ellenberg acknowledges “we’re in uncharted territory.” Last week, President Trump claimed the White House can overrule the FDA’s attempt to toughen its Covid-19 ...
CNN

BIOCARDIA ANNOUNCES POSITIVE DSMB RECOMMENDATION TO CONTINUE PHASE III PIVOTAL CARDIAMP HEART FAILURE STUDY, AS PLANNED

SAN CARLOS, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that ...
Nasdaq

Enlivex Announces Positive DSMB Recommendation to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis

Nes-Ziona, Israel, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the ...
News Medical

COVID-19 Vaccine DSMB can serve as model for future situations

Clinical evaluation of three COVID-19 vaccine candidates in 2020-21 during a worldwide pandemic that killed or sickened millions was unprecedented in terms of urgency and scope. Responsibility for the ...
CNN

The secretive group at the center of the nation’s largest vaccine trials

A group you’ve probably never heard of holds powerful sway over which coronavirus vaccines will end up on the market. It’s known as the DSMB. Members of a Data and Safety Monitoring Board are the only ...