Phase III
Avenue Therapeutics, announced its Phase III clinical trial of IV tramadol hit its primary endpoint of statistically significant improvement.
There are several companies facing decisions by the U.S. Food and Drug Administration (FDA) this upcoming week. However, it should be noted that because the upcoming weekend is the Memorial Day holiday in the United States, some of these decisions may be made before their dates to avoid the holiday. Here’s a look.
Johnson & Johnson’s Janssen division has decided to end its trials of atabacestat, a BACE inhibitor, for Alzheimer’s disease.
Danish company Novo Nordisk is a leader in diabetes treatment, but this week announced it was upping its commitment to stem-cell-based therapies and expanding its focus.
Amgen and Novartis scored a big win in the migraine market late Thursday when the U.S. Food and Drug Administration approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults.
Genentech, released follow-up data from its Phase III ALEX trial comparing its Alecensa (alectinib) to Pfizer’s Xalkori (crizotinib) in late-stage non-small cell lung cancer (NSCLC).
Regeneron Pharmaceuticals and its developmental partner Sanofi are eying the third quarter of this year to seek regulatory approval for Dupixent (dupilumab) as a potential monotherapy treatment for moderate-to-severe atopic dermatitis in adolescents.
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Evolus for its Biologics License Application (BLA) for DWP-450 (prabotulinumtoxinA), a drug to treat frown lines similar to Allergan’s Botox.
Eleven Biotherapeutics is rebranding itself as Sesen Bio and investors are pleased. This morning shares of Eleven are up more than 4 percent in premarket trading.
Eli Lilly continues to see positive news in its efforts to combat migraine headaches.
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