-
Clinical Trials & Development1 month agoCelldex sinks as safety concerns cloud immune drug results
Though barzolvolimab displayed what one analyst described as the best efficacy results to date against chronic skin hives, treatment was also associated with two life-threatening anaphylaxis cases.
-
Clinical Trials & Development1 month agoSTAT+: Novo may be getting a better deal than expected with Medicare’s Bridge program
Eli Lilly and Novo Nordisk were already benefitting a great deal from the Trump administration's pilot program covering obesity drugs for seniors at a price of...
-
Clinical Trials & Development1 month agoA Novel Stratum-Specific Trial Design Improves Statistical Power for Rare Diseases with Heterogenous Clinical Symptoms
CDER researchers developed a new stratum-specific statistical design shown to offer substantial increases in statistical power for clinical trials with small subpopulations that may be beneficial...
-
Clinical Trials & Development1 month agoCelldex monoclonal antibody rebounds with pair of phase 3 wins for chronic skin condition
Celldex touted a double phase 3 trial win in patients with treatment-refractory chronic spontaneous urticaria.
-
Clinical Trials & Development1 month ago
Vertex’s midstage data amplify kidney disease market opportunity
Vertex has reported positive phase 2b data for its kidney disease prospect inaxaplin, boosting its efforts to expand beyond the population targeted in a pivotal trial.
-
Clinical Trials & Development1 month agoEC approves Menarini and NewAmsterdam’s obicetrapib therapies
The authorisation allows both treatments to be used for patients with primary hypercholesterolaemia, including those with heterozygous familial and non-familial forms or mixed dyslipidaemia. This is...
-
Clinical Trials & Development1 month ago
Otsuka heads to FDA as Ionis-partnered ALS drug hits primary phase 3 endpoint
A phase 3 study of Otsuka and Ionis Pharmaceuticals’ amyotrophic lateral sclerosis drug candidate has hit its primary endpoint, positioning the partners to talk to regulators...
-
Clinical Trials & Development1 month ago
Roche’s GLP-1/GIP drug hits in phase 2 diabetes trial, fueling best-in-disease hopes
A phase 2 trial of Roche’s dual GLP-1/GIP receptor agonist has hit its primary endpoints, painting the drug candidate as a potential treatment for people with...
-
Clinical Trials & Development1 month ago
Positive Interim Data Shows Genentech’s Sefaxersen Significantly Reduces Proteinuria in People With IgA Nephropathy (IgAN)
South San Francisco, CA -- September 22, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today positive prespecified interim...
-
Clinical Trials & Development1 month agoBeacon edges ahead in XLRP gene therapy race with Phase III hit
BIOCENTURY | PRODUCT DEVELOPMENTBEACON EDGES AHEAD IN XLRP GENE THERAPY RACE WITH PHASE III HITBioCentury’s Clinical Report Sept. 15-21
Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
Genmab’s cancer bispecific delivers early OS win in ‘exceedingly positive’ Phase 3 readout
STAT+: HHS moves to allow compounding of some unapproved peptides
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
