FDA slaps enrollment hold on 2 Tecentriq studies after Keytruda myeloma trial deaths
September 19, 2017
By Neozene

Keytruda’s stumble in multiple myeloma has hit another of its peers. Roche said Friday that, because of deaths in Keytruda’s combo trials with Celgene medications, the FDA put a partial hold on certain Tecentriq studies so it can assess the situation. Roche is studying Tecentriq in multiple cancers, but it’s phase 1b and phase 1/2b studies in relapsed or treatment-resistant multiple myeloma and follicular lymphoma that are now on a partial hold as the FDA checks for a potential classwide safety concern—or an issue only with certain drug combos. Back

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US FDA Launching New Premarket Approval (PMA) Pilot Program for High-risk Medical Devices
September 14, 2017
By Neozene

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to launch a new pilot program to develop a more efficient premarket approval (PMA) market pathway for some high-risk medical devices. The pilot, called the Premarket Approval Application Critical to Quality (PMA CtQ) program, will commence on September 29, 2017. Starting on that date, CDRH will choose as many as nine PMA registrants to participate in the PMA CtQ pilot. PMA CtQ program goals According to CDRH, PMA CtQ entails a “focused inspectional approach” to the

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FDA to Unveil New Regulatory Framework for Stem Cell Therapies
August 31, 2017
By Neozene

The US Food and Drug Administration’s (FDA) Commissioner Scott Gottlieb said Monday the agency will advance a new framework to better regulate stem cell therapies this fall. “This comprehensive policy will establish clearer lines around when these regenerative medicine products have sufficient complexity to fall under the agency’s current authority, and then define an efficient process for how these products should be evaluated for safety and effectiveness,” Gottlieb said. The statement was sent out alongside a warning letter for a Florida stem cell clinic, known as US Stem Cell Clinic,

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