US FDA kicks 'moderate' out of ER/LA opioid pain indication, adds postmarket studies requirement
This article was originally published in SRA
Executive Summary
US regulators have ordered makers of extended-release (ER) and long-acting (LA) opioids, such as morphine, oxycodone and fentanyl, to add new warnings to the labeling of their products and revise the indications of the medicines as part of an effort to help curb the abuse and misuse of the drugs1,2.
You may also be interested in...
Long-Term Opioid Efficacy Studies Will Take Years, Gottlieb Says
Trials will be mandated as part of new authority granted by SUPPORT Act and are intended to determine whether opioid efficacy decreases with long-term use.
Moderna's Valera Takes mRNA Approach To Combat Zika
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan's Price Reform Pledge: Will Others Follow?
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.