Regulatory
Eisai Co., Ltd. has announced that a marketing authorization application has been submitted in Japan for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for use in the treatment of insomnia disorder.
Perhaps the biggest mover and shaker announcement this week was the unexpected resignation of Scott Gottlieb, commissioner of the U.S. Food and Drug Administration. Gottlieb will leave his post later this month to spend more time with his family.
Gottlieb announced his intention to leave the FDA earlier this week. The Trump administration will have a list of candidates to choose from as it moves forward.
The European Patent Office has granted a patent for Sangui’s proposed technology/treatment (SBT 102) for septic shock patients, effective March, 6, 2019*.
Biotech and pharma companies from across the globe share data and news in a weekly roundup.
Janssen believes the treatment works by restoring synaptic connections in brain cells in individuals with major depressive disorder.
Scott Gottlieb, the proactive commissioner of the U.S. Food and Drug Administration has resigned, according to reports. Gottlieb will leave the regulatory agency in about a month.
The U.S. Food and Drug Administration (FDA) accepted Celgene’s New Drug Application (NDA) for fedratinib for myelofibrosis. It also granted it a Priority Review, with a target action date of September 3, 2019.
Intrinsic Imaging, a global medical imaging core lab for clinical trials, announces that it recently underwent an extensive 5-day high priority Bioresearch Monitoring Program inspection by the U.S. Food and Drug Administration Center for Drug Evaluation and Research.
On Friday, the FDA raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals.
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