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April 9, 2014
05:16 EDTZGNXZogenix requested order staying the ban of Zohydro in MA
Today Zogenix presented its case in U.S. District Court in Boston requesting an immediate order staying the ban on the FDA-approved prescription drug product, Zohydro ER extended-release capsules, entered on March 27, by Massachusetts Governor Deval Patrick. A follow-up hearing has been scheduled for Monday, April 14. The company will continue to monitor, evaluate and take appropriate actions in all states specific to Zohydro ER to ensure that all FDA-approved Schedule II prescription opioids covered by the FDA mandated Risk Evaluation Mitigation Strategy for extended-release and long-acting opioid analgesics receive equal treatment for any rules that impact patient access and prescribing.
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July 14, 2014
08:36 EDTZGNXZogenix announces patent for DosePro Needle-free Delivery System
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July 9, 2014
08:33 EDTZGNXZogenix reports positive development on U.S. District Court ruling
Zogenix commented on the order issued by the U.S. District Court in Massachusetts upholding its prior decision that imposing regulations to restrict access to Zohydro ER Extended-Release Capsules, CII, violates Constitutional law. The court's decision supports the importance of upholding the principle at the heart of this case, which is that the FDA is the only regulatory body that is authorized to determine the approval and access of medicines for all Americans. On October 25, 2013, the FDA approved Zohydro ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, and today's decision preserves access for those in Massachusetts who may benefit from its medical attributes and sets a precedent for other states seeking to unjustly restrict access to Zohydro ER. Zogenix will continue to work to ensure patients have access to Zohydro ER in every state in a manner that is consistent with all extended-release opioids.

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