Panel agrees with agency that Genzyme’s pivotal trials for MS drug don’t meet FDA approval standards, then casts conflicting votes supporting drug.
FDA’s Peripheral and Central Nervous System cast a potentially fatal vote Nov. 13, agreeing with the agency that Genzyme Corp./Sanofi’s pivotal trials for multiple sclerosis candidate Lemtrada (alemtuzumab) were not adequate and well-controlled – necessary qualifications for drug approval.
But the panel quickly followed that vote with a supportive vote on the drug’s efficacy and later a vote that safety concerns associated with the biologic didn’t preclude approval, offering...
Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.
The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
