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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.
Ascendis Pharma, based in Copenhagen, Denmark, announced that its once-weekly TransCon Growth Hormone (hGH) hit its primary endpoints in its Phase III height Trial in children with pediatric growth hormone deficiency (GHD).
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.
MorphoSys AG announced that its licensee Janssen Research & Development, LLC, has reported that the U.S. Food and Drug Administration has approved Tremfya One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis.
BioSpace gathered together a roundup of global biopharma news from the past week. Bayer and Orion Corporation, Themis Bioscience, Axonics Modulation Technologies, and more are mentioned in this edition.
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