Regulatory
Pure Sunfarms’ large-scale facility with 16 grow rooms is optimized for year-round production and expected to yield more than 80 harvests annually
FDA accepts study protocol, providing green light for GENFIT to initiate Phase 2 clinical trial in pediatric NASH
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It blocks interactions with both PD-1 and B7.1 receptors.
The next couple of weeks look to be busy for the FDA, with a string of target action dates scheduled. This week marks three scheduled approvals, two for extra indications for already-approved biologics, and the third for a combination treatment for glaucoma. Here’s a look.
Sanofi has been hoping to secure approval from the U.S. Food and Drug Administration for its dengue vaccine, but a mixed review from a panel of experts could sink the chances of a green light for the medication.
The U.S. Food and Drug Administration (FDA) and some biosimilar and generic drug advocates were concerned that the naming for biosimilars—the branded drug’s name and a unique, four-letter suffix—made the drugs sound inferior to consumers than their branded counterparts.
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*.
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