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Regulatory NEWS
BOGOTA, Colombia – Biosimilar makers and distributors are looking at the small but growing markets in Latin America to not only reach new consumers, but also pave the way for entry into more developed markets.
Biosimilar sponsors are looking to put their best foot forward now that the Federal Circuit has agreed with a lower court that they don't have to dance to the tune of the Biologic Price Competition and Innovation Act's (BPCIA) intricate patent information exchange.
LONDON - The EMA is making moves to increase the number of drugs approved for use in children, revoking eight of the 32 class waivers currently in force, which free companies of any obligation to develop products for pediatric use, and revising 15 others.
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