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A U.S. court has ruled in favor of the FDA in a case filed by Vanda Pharmaceuticals alleging the agency didn’t provide an adequate scientific reason for a partial clinical hold issued in December 2018 for the company’s long-term study of tradipitant. Read More
In the wake of declaring the coronavirus a global emergency, the World Health Organization (WHO) has issued a new procedure for drugmakers that wish to submit unapproved drug products for public health crises. Read More
The vendor was charged with receiving $1 million from an unnamed opioid drugmaker to create an alert aimed at pushing doctors to prescribe more extended-release opioids. Read More
Sponsors of biologics and biosimilars should carefully consider how they present safety and efficacy information in their promotional materials, the FDA said in a draft guidance released yesterday. Read More
The European Medicines Agency issued a draft paper to clarify the responsibilities of marketing authorization holders (MAHs) under the EU’s GMP regulations, which the EMA conceded can be confusing. Read More
The Institute for Clinical and Economic Review (ICER) has updated its drug value assessment process for 2020 to include more real-world evidence, a one-year reevaluation and other new elements. Read More
The Trump administration last week unveiled a pilot Medicaid program that would allow participating states to negotiate drug prices by choosing the drugs covered for certain adults under age 65 — an approach that PhRMA strongly opposes. Read More