Drug Development
Sales of Johnson & Johnson’s esketamine-based nasal spray jumped in the fourth quarter last year, priming the pump for a suite of other pharmas, including AbbVie, champing at the bit with their own psychedelics.
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After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
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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.
EmpowerDX, a Eurofins subsidiary, just launched its direct-to-consumer COVID-19 Home Collection Kit in the U.S. through Amazon, making it one of a miniscule number of at-home and over-the-counter kits that are putting detection of the SARS-CoV-2 virus in the hands of patients.
Shares of GenMark Diagnostics are soaring in premarket trading after Roche announced it was acquiring the California-based company in a $1.8 billion deal to bolster its own diagnostics pipeline.
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.
This morning, the World Health Organization issued a statement that there is no reason to stop using the vaccine because, as of this time, “no causal link has been established.”
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.