Merck announced that remigromig, a tri-specific antibody acquired in a $1.3 billion buyout, achieved its primary endpoint in the pivotal Phase 2b/3 BRUNELLO trial for diabetic macular edema. However, language regarding the drug's safety profile has raised concerns among analysts.
A nationwide Danish study found that oral menopausal hormone therapy is associated with elevated risk of venous thromboembolism regardless of dose, while high-dose oral forms also increased stroke and heart attack risk. Transdermal treatments showed no overall increase in thrombotic risk.
Celldex Therapeutics' barzolvolimab achieved what analysts called best-in-class efficacy results in two Phase 3 trials for chronic spontaneous urticaria, meeting all primary and key secondary endpoints. However, the trials also reported two life-threatening anaphylaxis cases, causing shares to drop 13-15% despite the positive efficacy data.
The European Medicines Agency has launched an investigation into injectable iron medicines after reports of severe hypophosphatemia leading to osteomalacia, including cases occurring after just one or two doses in patients without recognized risk factors.
The FDA halted testing of Regenxbio's gene therapy for Hunter Syndrome after spinal MRI scans detected abnormalities in five trial participants. This is the second clinical hold placed on a Regenxbio gene therapy program.
Two Republican members of the House of Representatives are urging the FDA to reject clinical data from China unless trial sites have been recently audited by the agency, following reports of three patient deaths in separate gene therapy clinical trials conducted in China.
Medical experts specializing in Prader-Willi syndrome flagged serious adverse events in patients taking Neurocrine Biosciences' drug Vykat XR, raising safety concerns about the treatment for the rare genetic disorder.
Vistagen announced topline results from a repeat dose study of fasedienol for acute treatment of social anxiety disorder, showing favorable safety and tolerability profiles along with efficacy signals across primary and secondary endpoints in both repeat and single dose administrations.
India's drug regulator has taken enforcement action against approximately 90% of inspected pharmaceutical facilities identified as high-risk under a nationwide quality initiative, as authorities intensify oversight amid increased global scrutiny of Indian-made drugs.
Lawsuits over vision loss risks from Saxenda (liraglutide) emerge as Medicare begins covering GLP-1 medications for seniors over 65, raising questions about proper usage and safety in older populations.
The New England Journal of Medicine retracted the main clinical trial used to approve Amgen's $500 million drug Tavneos, following allegations of data manipulation. The European Medicines Agency had previously recommended revoking the drug's approval over data integrity concerns.
ADC Therapeutics shares plunged 53% in premarket trading after a late-stage study of its blood cancer drug showed more deaths among treated patients, despite meeting its main goal. The safety signal represents a significant setback for the company's development program.
Swiss drugmaker Roche presented latest clinical trial data for its experimental multiple sclerosis drug at a major conference, setting the stage for regulatory approval submissions, though safety questions remain under scrutiny.
