Compounding Drug Development Drug Pricing Immunity 
Pharmacy Times
JUNE 23, 2025
CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.
pharmaphorum
AUGUST 27, 2020
Regulatory pressures, lengthy drug development times, and the fact that drug prices have become politicised have raised risks and cut revenue projections, leading to the biotech sector falling out of fashion. The first is that the development of vaccines is utilising cutting edge technologies.
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