Regulatory
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.
Esperion announced that the company has successfully completed important and key global marketing applications including the submission of two New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet to the U.S. Food and Drug Administration.
PRESS RELEASES