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A federal appeals court has affirmed Shire Pharmaceuticals’ patents for Vyvanse, blocking efforts by five drugmakers to market generic versions of the attention deficit hyperactivity disorder drug. Read More
An interim report shows that the FDA has conducted nearly 90 meetings with more than 50 drug companies interested in producing biosimilar products since 2013 at a cost of $65.9 million. Read More
The FDA awarded a three-year contract to the American Society of Health-System Pharmacists to develop and implement standardized concentrations for intravenous and oral liquid medicines as part of the agency’s Safe Use Initiative. Read More
The FDA has awarded research grants totaling more than $19 million to boost the development of products to treat 17 different rare diseases, many of which have little or no available treatment options. Read More
The U.S. government is awarding $62 million to Regeneron Pharmaceuticals and Inovio Pharmaceuticals to support their ongoing development of novel Ebola virus treatments. Read More
Drugmakers making changes to analytical methods over the lifecycle of a drug should retain samples to permit comparative studies of the new and old methods, the FDA says. Read More
Drugmakers in the EU have less than seven months to conduct risk assessments of all the excipients they use under good manufacturing practices guidelines imposed by the European Commission. Read More
CDER Director Janet Woodcock came under fire Thursday from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars. Read More