Phase III
Over 52-Weeks, Bempedoic Acid was Observed to be Safe, Well-Tolerated, and Adverse Event Profile was Similar to that of Placebo
The FDA, as part of efforts to update clinical trial eligibility criteria, published four draft guidance documents on cancer clinical trial criteria and one final draft on adolescents in adult oncology trials.
While the primary endpoint of disease-free survival was not met, Celgene said overall survival, which was a secondary endpoint, was improved by the combination treatment.
Sterna biologicals GmbH & Co. KG announced that the company held two Scientific Advisory Board (SAB) meetings to evaluate the phase IIb clinical development program for SB010 in asthma.
The U.S. Food and Drug Administration has been busy approving new treatments for various diseases. Two days into the new week and the regulatory agency has green lit two therapeutics, while other companies are planning to file for potential approval.
Auris Medical Holding AG announced the publication of an article that presents and discusses in detail the outcomes from the HEALOS Phase 3 trial with AM-111, Auris Medical’s investigational treatment for acute inner ear hearing loss.
Shares of AMAG Pharmaceuticals plunged more than 17 percent Friday after the company said its Phase III PROLONG trial of Makena failed to demonstrate a statistically significant difference from placebo in preventing preterm births.
Takeda Pharmaceutical’s Entyvio outperformed AbbVie’s Humira in a head-to-head comparison in treating ulcerative colitis during a late-stage study, the company said.
In a phase 3 clinical trial, tenapanor significantly lowered elevated blood phosphate in patients receiving maintenance hemodialysis, resulting in an average reduction of 1.0–1.2 mg/dL over 8 weeks.
Often, patients prefer oral medications over receiving an injection or infusion, but daily pills sometimes result in compliance problems. In the case of this combination injection, it would, if approved, require patients to visit a clinic or physician once a month for the shot.
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