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The panel concluded that the absence of in vitro neutralization activity strongly suggests absence of clinical effectiveness of these monoclonal antibodies. Read More
There are only twelve days until Sept. 30, the end of the fiscal year — the point at which the FDA faces potentially laying off thousands of employees if user fee legislation isn’t reauthorized by Congress — and yet Congress still has not completed the vital legislation. Read More
An expert panel of the European Medicines Agency (EMA) recommended 12 new drugs and embraced therapeutic extensions for 11 medicines already authorized in the EU at its latest monthly meeting held from September 12 to 15. Read More
Clarifying how government- and sponsor-paid experts can sometimes aid sponsors in meetings with FDA, the agency updated its Manual of Policies and Procedures (MAPP) concerning special government employees (SGEs) who represent sponsors before the agency’s Center for Drug Evaluation and Research (CDER). Read More
Novartis released a statement Thursday saying it was the target of a dawn raid by the Swiss Competition Commission (COMCO) regarding misuse of a patent for a dermatology drug. Read More
“Quiet quitting” is not for everyone. Nearly 20 percent of regulatory affairs professionals switched jobs in 2021 seeking better pay, work/life balance, and a more diverse workplace, according to the Global Compensation and Scope of Practice Survey, conducted by the Regulatory Affairs Professionals Society (RAPS) and released during the group’s annual meeting in Phoenix earlier this week. Read More
In a pair of new reports, nonprofit research group the Institute for Clinical and Economic Review (ICER) assessed the cost benefit analyses for oral therapies treating amyotrophic lateral sclerosis (ALS) and gene therapies for use against hemophilia. Read More