Charleston Laboratories, Inc.
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Latest From Charleston Laboratories, Inc.
Will Amylyx’s ALS Drug Benefit From US FDA’s Aduhelm Experience?
A rare second advisory committee meeting is scheduled for Amylyx’s ALS drug to discuss additional analyses that the company submitted, allowing another glimpse into the FDA’s pre-decision thinking.
PDUFA VII Could Increase Transparency Of REMS Release Process
Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.
Closing The Books On Purdue – And US FDA’s Policies To Control Opioids
A massive settlement of opioid litigation is intended to end the era of opioid marketing defined by OxyContin. It also like closes the books on efforts to rely on the US FDA to control the prescription abuse crisis.
Discomfort With REMS Highlighted At Negative Hydexor Advisory Committee
US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.
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