Government
The FDA advisory committee canceled the meeting after Intra-Cellular provided the regulatory agency with additional data. No new meeting date has been scheduled.
Braeburn has been fighting the FDA over its award of Orphan Drug Designation to another opioid use disorder treatment that will prevent competition through November 2020. More than 2 million people in the U.S. have been diagnosed with the disease.
FDA’s Sharpless Outlines Agency’s 4 Top Priorities: Tech, Hiring, Modernization and Increased Safety
In terms of modernizing frameworks, Sharpless focused on the agency’s efforts to approve generic drugs and biosimilars more quickly in order to lower drug prices. He also said the FDA needed to help the biopharma industry with “the most expensive part of drug discovery and development,” referring to clinical testing.
It is approved for adults with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.
Despite the approval, Samsung Bioepis’ Hadlima will not be available in the U.S. until 2023, due to licensing deals with AbbVie, the maker of Humira.
Myxredlin is intended for use only in acute care settings under medical supervision.
The drug is approved for use for management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for partial-onset seizures in patients 17 years of age and older, fibromyalgia, and neuropathic pain associated with spinal cord injury.
The FDA approval marks the first for oral ulcers associated with Behçet’s Disease and the third for Otezla.
Here’s a look at the top clinical trial news from last week, with updates from Neon, GSK, Biohaven, and more.
A federal judge ordered that information on sales of opioids up to the year 2013 could be released.
PRESS RELEASES