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Resolving allegations that it violated the False Claims Act, generic drugmaker Akorn has entered into a settlement to pay $7.9 million for causing Medicare to be billed for three over-the-counter (OTC) drugs that were no longer eligible for Medicare coverage. Read More
Vanda Pharmaceuticals is suing the FDA for the third time in 2022 — this time over what the company claims is FDA’s “unlawful” delay in granting a public hearing to Vanda regarding expanding the approval of the company’s sleep disorder drug Hetlioz (tasimelteon) to also include the treatment of jet lag disorder. Read More
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