Clinical research
Sanofi and Regeneron Pharmaceuticals’ checkpoint inhibitor Libtayo performed so well that the regulators anticipate that the trials may need to be halt early.
Many drugs for Alzheimer’s disease have demonstrated promise in early and mid-stage clinical trials, but then go on to fail in larger late-stage trials. It’s too early to know if that will be the case with Eli Lilly’s donanemab, but it showed unusually good primary results in a Phase II trial, with decidedly mixed secondary endpoint results.
The second half of March is a busy month for the U.S. Food and Drug Administration (FDA), with quite a few PDUFA dates scheduled. Here’s a look at this week’s target action dates.
It was another busy week for clinical trial announcements. Here’s a look including trials for COVID-19, migraine, Parkinson’s disease, Alzheimer’s, HIV and more.
The European Medicines Agency has launched a safety review of bluebird bio’s thalassaemia drug Zynteglo, a conditionally licensed gene therapy in Europe.
Today, AVEO Oncology announced it had inked a clinical trial collaboration and supply deal with Bristol Myers Squibb to study Fotivda in combination with BMS’s checkpoint inhibitor Opdivo in advanced r/r RCC after previous immunotherapy exposure.
While existing vaccines are being rolled out worldwide, Novavax’s is demonstrating effectiveness in late-stage trials and the partnership of Sanofi and Translate Bio is beginning early-stage trials for their mRNA vaccine.
Patients in a Phase II trial have begun receiving Moderna’s vaccine against the SARS-CoV-2 variant first identified in South Africa, the company announced.
Genentech reported its rheumatoid arthritis drug Actemra failed to hit its primary endpoint in a COVID-19 trial, while Vir and GlaxoSmithKline’s antibody against COVID-19 demonstrated 85% efficacy.
Preliminary findings of LentiGlobin suggested that the BB305 LVV vector was present in the AML blast cells, but there was not sufficient information to determine causality.
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