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Despite failing to achieve both its primary and secondary phase 2 endpoints, an investigational oral solution of gold nanocrystals will go forward into open-label extension studies after a subanalysis found a strong survival benefit in the 30 mg dosing group. Read More
Zealand Pharma’s investigational glucagon-like peptide (GLP)-2 analog glepaglutide hit its primary phase 3 endpoint of reducing parenteral nutrition volume in patients with short bowel syndrome, but only when given twice a week. Read More
Verdiperstat, Biohaven’s investigational drug for amyotrophic lateral sclerosis (ALS), didn’t pass its phase 3 muster, failing to slow progression of the fatal muscle-wasting disease. Read More
Biogen and developmental partner Esai are touting positive phase 3 data for their antiamyloid antibody lecanemab, saying the drug slowed cognitive decline by 27 percent among 1,795 patients with early Alzheimer’s disease. Read More
The FDA has placed a partial clinical hold on Avidity Biosciences’ phase 1/2 MARINA study after one person treated with AOC 1001, an investigational gene therapy for myotonic dystrophy type 1 (DM1), experienced a serious adverse event. Read More
Biogen’s investigational drug for SOD1 amyotrophic lateral sclerosis (ALS), tofersen, has delivered more promising results in an extension study published in the New England Journal of Medicine. Read More
Merck has found a way forward for its stalled oral antiretroviral islatravir, using a lower, 0.75 mg dose in three newly launched phase 3 trials and in a previously paused phase 2 trial that has been languishing under a clinical hold after patients developed decreases in total lymphocyte and CD4+ T-cells. Read More
After a series of rejections, the FDA has finally approved Mallinckrodt’s Terlivaz (terlipressin) for treating adults suffering from hepatorenal syndrome (HRS), a life-threatening condition involving rapid reduction in kidney function. Read More
A spate of phase 3 data hit the wires this week. Here’s a brief look at the numbers from Alexion, Merck, AstraZeneca and Bristol Myers Squibb. Read More