US FDA is understandably feeling vindicated about the decision to use beta amyloid as a surrogate marker in Alzheimer’s. But the agency needs to be careful because critics of its landmark accelerated approval decision for Aduhelm are not arguing about the science.
When it comes to the role of beta amyloid as a surrogate marker for disease progression in Alzheimer’s, it is very understandable if US Food & Drug Administration officials are tempted to say, “I told you so.”
The agency’s 2021 decision to grant accelerated approval to Biogen, Inc.’s Aduhelm (aducanumab-avwa) based on that biomarker prompted a...
Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .
Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
